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Background: The incidence of Mirizzi Syndrome ranges from 0.05 to 5.7 % of patients who undergo cholecystectomy. The purpose of this study is to examine the preoperative workup and postoperative outcomes for patients diagnosed with Mirizzi Syndrome. Methods: Retrospective chart review was conducted between January 2018 and January 2022 at a single institution. All adult patients who underwent cholecystectomy were included. Results: 1628 patients underwent cholecystectomy of which 47 were diagnosed with Mirizzi Syndrome. The majority of patients had type 1 Mirizzi Syndrome. Preoperative studies were often nondiagnostic and 81 % of cases were diagnosed intraoperatively. 66 % of cases were performed laparoscopically, an open approach was required for type V Mirizzi Syndrome. The complication rate was 25 %; most commonly a bile leak requiring ERCP. Conclusion: Mirizzi syndrome is more common than previously expected and related to patient's ability to seek timely medical care. Most cases can be completed laparoscopically however there is a high rate of complications. Key message: This study presents an additional cohort of patients found to have Mirizzi syndrome and supports the hypothesis that it is difficult to diagnose preoperatively. Cases should be attempted laparoscopically but there remains a high complication rate.

Background: Lumbar disc herniation (LDH) is a common condition that can be characterized with disabling pain. While most patients recover without surgery, some still require operative intervention. The epidemiology and trends of laminotomy for LDH have not been recently studied, and current practice patterns might be different from historical norms. This study aimed to investigate the trends of inpatient and outpatient laminotomies for LDH and compare complication rates between these two sites of service. Methods: A large, national database was utilized to identify patients >8 years old who underwent a laminotomy for LDH between 2009 and 2019. Two cohorts were created based on site of surgery: inpatient versus outpatient. The outpatient cohort was defined as patients who had a length of stay less than 1 day without any associated hospitalization. Epidemiologic analyses for these cohorts were performed by demographics. Patients in both groups were then 1:1 propensity-score matched based on age, sex, insurance type, geographic region, and comorbidities. Ninety-day postoperative complications were compared between cohorts utilizing multivariate logistic regressions. Results: The average incidence of laminotomy for LDH was 13.0 per 10,000 persons-years. Although the national trend in incidence had not changed from 2009 to 2019, the proportion of outpatient laminotomies significantly increased in this time period (p=.02). Outpatient laminotomies were more common among younger and healthier patients. Patients with inpatient laminotomies had significantly higher rates of surgical site infections (odds ratio [OR] 1.61, p

Background: The data for primary triage via telemedicine for spine related conditions are sparse but has potential to improve access, quality of care, and offer significant cost savings for Medicaid insured patients who have very limited access to care. The purpose of this study was to evaluate the feasibility and acceptability of implementing a telehealth triage framework using synchronous video conferencing appointments. Methods: This is a prospective cohort feasibility study conducted within an academic spine center in the United States. Participants include Medicaid insured patients referred to an academic spine center for low back pain. We collected demographic information, a spine red flag survey, a patient satisfaction survey and demand and implementation feasibility metrics. Participants completed a demographic and red-flag survey followed by a telehealth spine appointment with a physiatrist. Immediately after the appointment, the participant completed a satisfaction survey. Results: Nineteen patients met inclusion criteria but declined telehealth either due to preference for in-person appointment or lack of comfort with technology. Thirty-three participants enrolled and attended their initial telehealth appointment. Few participants reporting 1 or more red flag symptom also screened positive during their subsequent telehealth evaluation with the physician (n=7/28). Participant satisfaction was high across all domains including ease of scheduling, efficiency of virtual check in, ability to report their symptoms fully and accurately to the provider, imaging review, explanation of diagnosis and treatment plan. Most participants (n=19/20, 95%) would recommend an initial telehealth appointment. Conclusions: The telehealth framework used was feasible and provided an acceptable form of care for Medicaid patients who were interested and able to participate in this form of care. Our acceptability results are promising but should be interpreted with caution given the proportion of patients who declined to participate.

At some point as the on-call trauma surgeon, you may need to operate on a bleeding lung. This concise review addresses preoperative and intraoperative considerations for traumatic lung injuries, including how to deal with specific findings at the time of surgery.

Background: A recent feasibility assessment of quality indicators for nonvalvular atrial fibrillation/atrial flutter (NVAF/AFL) identified the Canadian Primary Care Sentinel Surveillance Network, a national outpatient electronic medical record (EMR) system, as a data source for measurement. As a first step, we adapted and validated an existing EMR case definition. Methods: A diagnosis of NVAF/AFL was defined using International Classification of Disease, 9th Revision, Clinical Modification codes (427.3) in either the physician billing, encounter diagnosis, or health condition fields. We identified all presumed cases in a single clinical site with the algorithm and selected a random sample of those who were presumed NVAF/AFL negative with the same algorithm. A chart audit diagnosis of “definite” NVAF/AFL was confirmed by electrocardiogram and nonvalvular diagnosis confirmed after echocardiogram, attending physician, or specialist letter review. To demonstrate face validity, clinical characteristics were compared for patients with and without NVAF/AFL. Results: The case definition identified a possible 184 patients with and 184 without NVAF/AFL. The case validation resulted in a sensitivity of 100% (95% confidence interval [CI], 100-100), specificity of 84.3% (95% CI, 78.8-89.9), and positive and negative predictive value of 74.7% (95% CI, 66.4-83.2) and 100% (95% CI 100-100), respectively. Patients with NVAF/AFL were older (63 vs 42 years) and had a higher proportion of cardiovascular comorbidities and relevant medications. Conclusions: We think it is possible that with further validation work, NVAF/AFL can be accurately identified using this large pan-Canadian EMR system and used as a future tool to measure quality of care in the outpatient setting. Résumé: Contexte: Dans le cadre d’une étude récente visant à déterminer s’il est possible d’utiliser des indicateurs de qualité pour évaluer les soins prodigués en cas de fibrillation auriculaire (FA) non valvulaire/flutter auriculaire, le Réseau canadien de surveillance sentinelle en soins primaires, un système national regroupant des données provenant des dossiers médicaux électroniques (DME) de patients vus en contexte de soins ambulatoires, a été retenu comme source de données pour une telle évaluation. Dans un premier temps, nous avons adapté et validé une définition de cas existante dans les DME. Méthodologie: On considérait qu’il y avait diagnostic de FA non valvulaire/flutter auriculaire si le code de la Classification internationale des maladies (9e révision, Modification clinique) correspondant (code 427.3) figurait dans un des champs de facturation des actes médicaux, des diagnostics de consultation ou des problèmes de santé du DME. Nous avons relevé tous les cas de FA non valvulaire/flutter auriculaire présumés d’une même clinique à l’aide de l’algorithme établi et constitué un échantillon aléatoire de patients qui, selon le même algorithme, ne présentaient pas de FA non valvulaire/flutter auriculaire. On a ensuite vérifié les dossiers pour confirmer le diagnostic; le cas de FA non valvulaire/flutter auriculaire était « certain » si le dossier comprenait un électrocardiogramme positif et un diagnostic confirmé par échocardiographie, ou une note du médecin traitant ou d’un spécialiste confirmant le diagnostic. Pour démontrer la validité apparente de l’algorithme, les caractéristiques cliniques des patients atteints de FA non valvulaire/flutter auriculaire ont été comparées à celles des patients sans FA non valvulaire/flutter auriculaire. Résultats: La définition de cas a permis de repérer 184 patients ayant possiblement une FA non valvulaire/flutter auriculaire, et 184 autres patients sans FA non valvulaire/flutter auriculaire. À l’issue de la validation, la sensibilité de la définition de cas s’établissait à 100 % (intervalle de confiance [IC] à 95 % : 100 à 100), sa spécificité, à 84,3 % (IC à 95 % : 78,8 à 89,9), et ses valeurs prédictives positive et négative, à respectivement 74,7 % (IC à 95 % : 66,4 à 83,2) et 100 % (IC à 95 % : 100 à 100). Les patients atteints de FA non valvulaire/flutter auriculaire étaient plus âgés (63 vs 42 ans) et recevaient un traitement pour des affections cardiovasculaires concomitantes dans une plus forte proportion. Conclusions: Nous croyons qu’en approfondissant les travaux de validation, il serait possible de repérer avec précision les cas de FA non valvulaire/flutter auriculaire à partir des données de ce système pancanadien de surveillance des DME et de les utiliser pour évaluer la qualité des soins aux patients vus en contexte ambulatoire.

Background: Treatment outcomes after pelvic organ prolapse surgery are often presented as dichotomous "success or failure" based on anatomic and symptom criteria. However, clinical experience suggests that some women with outcome "failures" are asymptomatic and perceive their surgery to be successful and that other women have anatomic resolution but continue to report symptoms. Characterizing failure types could be a useful step to clarify definitions of success, understand mechanisms of failure, and identify individuals who may benefit from specific therapies., Objective: This study aimed to identify clusters of women with similar failure patterns over time and assess associations among clusters and the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, Patient Global Impression of Improvement, patient satisfaction item questionnaire, and quality-adjusted life-year., Study Design: Outcomes were evaluated for up to 5 years in a cohort of participants (N=709) with stage ≥2 pelvic organ prolapse who underwent surgical pelvic organ prolapse repair and had sufficient follow-up in 1 of 4 multicenter surgical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical success was defined as a composite measure requiring anatomic success (Pelvic Organ Prolapse Quantification system points Ba, Bp, and C of ≤0), subjective success (absence of bothersome vaginal bulge symptoms), and absence of retreatment for pelvic organ prolapse. Participants who experienced surgical failure and attended ≥4 visits from baseline to 60 months after surgery were longitudinally clustered, accounting for similar trajectories in Ba, Bp, and C and degree of vaginal bulge bother; moreover, missing data were imputed. Participants with surgical success were grouped into a separate cluster., Results: Surgical failure was reported in 276 of 709 women (39%) included in the analysis. Failures clustered into the following 4 mutually exclusive subgroups: (1) asymptomatic intermittent anterior wall failures, (2) symptomatic intermittent anterior wall failures, (3) asymptomatic intermittent anterior and posterior wall failures, and (4) symptomatic all-compartment failures. Each cluster had different bulge symptoms, anatomy, and retreatment associations with quality of life outcomes. Asymptomatic intermittent anterior wall failures (n=150) were similar to surgical successes with Ba values that averaged around -1 cm but fluctuated between anatomic success (Ba≤0) and failure (Ba>0) over time. Symptomatic intermittent anterior wall failures (n=82) were anatomically similar to asymptomatic intermittent anterior failures, but women in this cluster persistently reported bothersome bulge symptoms and the lowest quality of life, Short-Form Six-Dimension health index scores, and perceived success. Women with asymptomatic intermittent anterior and posterior wall failures (n=28) had the most severe preoperative pelvic organ prolapse but the lowest symptomatic failure rate and retreatment rate. Participants with symptomatic all-compartment failures (n=16) had symptomatic and anatomic failure early after surgery and the highest retreatment of any cluster., Conclusion: In particular, the following 4 clusters of pelvic organ prolapse surgical failure were identified in participants up to 5 years after pelvic organ prolapse surgery: asymptomatic intermittent anterior wall failures, symptomatic intermittent anterior wall failures, asymptomatic intermittent anterior and posterior wall failures, and symptomatic all-compartment failures. These groups provide granularity about the nature of surgical failures after pelvic organ prolapse surgery. Future work is planned for predicting these distinct outcomes using patient characteristics that can be used for counseling women individually., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: The ideal measure of success after surgery for pelvic organ prolapse has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes is equally or more important when comparing the success of various prolapse surgeries. Understanding the limitations of existing outcome definitions will guide surgical outcome reporting and comparisons of pelvic organ prolapse surgeries., Objective: This study aimed to describe the relationships and overlap among the participants who met the anatomic, subjective, and retreatment definitions of success or failure after pelvic organ prolapse surgery; demonstrate rates of transition between success and failure over time; and compare scores from the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years among these definitions., Study Design: Definitions of surgical success were evaluated at 3 or 6, 12, 24, 36, 48, and 60 months after surgery for ≥stage II pelvic organ prolapse in a cohort of women (N=1250) from 4 randomized clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical failure was defined by a composite measure requiring 1 or more of (1) anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of >0), (2) subjective failure (presence of bothersome vaginal bulge symptoms), or (3) pessary or surgical retreatment for pelvic organ prolapse. Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years were compared among participants who met a variety of definitions of success and failure including novel "intermittent" success and failure over time., Results: Among the 433 of 1250 women (34.6%) who had surgical failure outcomes at ≥1 time point, 85.5% (370 of 433) met only 1 component of the composite outcome at the assessment of initial failure (anatomic failure, 46.7% [202 of 433]; subjective failure, 36.7% [159 of 433]; retreatment, 2.1% [9 of 433]). Only 12.9% (56 of 433) met the criteria for both for anatomic and subjective failure. Despite meeting the criteria for failure in primary study reporting, 24.2% of these (105 of 433) transitioned between success and failure during follow-up, of whom 83.8% (88 of 105) met the criteria for success at their last follow-up. There were associations between success or failure classification and the 1- and 2-year quality-adjusted life years and a time-varying group effect on Pelvic Organ Prolapse Distress Inventory and Short-Form Six-Dimension health index scores., Conclusion: True failure rates after prolapse surgery may be overestimated in the current literature. Only 13% of clinical trial subjects initially met both subjective and objective criteria for failure. Approximately one-quarter of failures were intermittent and transitioned between success and failure over time, with most intermittent failures being in a state of "surgical success" at their last follow-up. Current composite definitions of success or failure may result in the overestimation of surgical failure rates, potentially explaining, in part, the discordance with low retreatment rates after pelvic organ prolapse surgery., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Little is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse., Objective: The objectives of the study were to describe postoperative pain and functional activity after transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling and to compare these outcomes between patients receiving 2 common transvaginal prolapse repairs, uterosacral ligament, and sacrospinous ligament vaginal vault suspension., Study Design: This planned secondary analysis of a 2 × 2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2-4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers. Participants were also randomized to receive perioperative pelvic muscle therapy or usual care. All patients received transvaginal native tissue repairs and a midurethral sling. Participants completed the Surgical Pain Scales (0-10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0-100; higher score = higher activity) prior to surgery and at 2 weeks, 4-6 weeks, and 3 months postoperatively. The MOS 36-item Short-Form Health Survey was completed at baseline and 6, 12, and 24 months after surgery; the bodily pain, physical functioning, and role-physical subscales were used for this analysis (higher scores = less disability). Self-reported pain medication use was also collected., Results: Before surgery, average pain at rest and during normal activity were (adjusted mean ± SE) 2.24 ± 0.23 and 2.76 ± 0.25; both increased slightly from baseline at 2 weeks (+0.65, P = .004, and +0.74, P = .007, respectively) and then decreased below baseline at 3 months (-0.87 and -1.14, respectively, P < .001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4-6 weeks (-1.26, P = .014, and -0.95, P = .002) and 3 months (-1.97 and -1.50, P < .001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4-6 weeks (+9.24, P < .001) and 3 months (+13.79, P < .001). The MOS 36-item Short-Form Health Survey Bodily Pain, Physical Functioning, and Role-Physical Scales demonstrated significant improvements from baseline at 6, 12, and 24 months (24 months: +5.62, +5.79, and +4.72, respectively, P < .001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery and 53.7% at 2 and 26.1% at 4-6 weeks postoperatively; thereafter use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of nonnarcotic pain medication was reported by 48.1% of participants prior to surgery, 68.7% at 2 weeks, and similar to baseline at 3 months; thereafter use dropped steadily to 26.6% at 2 years. Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4-6 weeks postoperatively (4.6% vs 10.5%, P = .043) but no difference in groin or thigh pain., Conclusion: Pain and functional activity improve for up to 2 years after native tissue reconstructive surgery with uterosacral or sacrospinous vaginal vault suspension and midurethral sling for stages 2-4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4-6 weeks., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Utility preference scores are standardized, generic, health-related quality of life (HRQOL) measures that quantify disease severity and burden and summarize morbidity on a scale from 0 (death) to 1 (optimal health). Utility scores are widely used to measure HRQOL and in cost-effectiveness research., Objective: To determine the responsiveness, validity properties, and minimal important difference (MID) of utility scores, as measured by the Short Form 6D (SF-6D) and EuroQol (EQ-5D), in women undergoing surgery for pelvic organ prolapse (POP)., Materials and Methods: This study combined data from 4 large, U.S., multicenter surgical trials enrolling 1321 women with pelvic organ prolapse. We collected condition-specific quality of life data using the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). A subset of women completed the SF6D; women in 2 trials also completed the EQ5D. Mean utility scores were compared from baseline to 12 months after surgery. Responsiveness was assessed using effect size (ES) and standardized response mean (SRM). Validity properties were assessed by (1) comparing changes in utility scores at 12 months between surgical successes and failures as defined in each study, and (2) correlating changes in utility scores with changes in the PFDI and PFIQ. MID was estimated using both anchor-based (SF-36 general health global rating scale "somewhat better" vs "no change") and distribution-based methods., Results: The mean SF-6D score improved 0.050, from 0.705 ± 0.126 at baseline to 0.761 ± 0.131 at 12 months (P < .01). The mean EQ-5D score improved 0.060, from 0.810 ± 0.15 at baseline to 0.868 ± 0.15 at 12 months (P < .01). The ES (0.13-0.61) and SRM (0.13-0.57) were in the small-to-moderate range, demonstrating the responsiveness of the SF-6D and EQ-5D similar to other conditions. SF-6D and EQ-5D scores improved more for prolapse reconstructive surgical successes than for failures. The SF-6D and EQ-5D scores correlated with each other (r = 0.41; n = 645) and with condition-specific instruments. Correlations with the PFDI and PFIQ and their prolapse subscales were in the low to moderate range (r = 0.09-0.38), similar to other studies. Using the anchor-based method, the MID was 0.026 for SF-6D and 0.025 for EQ-5D, within the range of MIDs reported in other populations and for other conditions. These findings were supported by distribution-based estimates., Conclusion: The SF-6D and EQ-5D have good validity properties and are responsive, preference-based, utility and general HRQOL measures for women undergoing surgical treatment for prolapse. The MIDs for SF-6D and EQ-5D are similar and within the range found for other medical conditions., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Little progress has been made in the prevention of pelvic floor disorders, despite their significant health and economic impact. The identification of women who are at risk remains a key element in targeting prevention and planning health resource allocation strategies. Although events around the time of childbirth are recognized clinically as important predictors, it is difficult to counsel women and to intervene around the time of childbirth because of an inability to convey a patient's risk accurately in the presence of multiple risk factors and the long time lapse, which is often decades, between obstetric events and the onset of pelvic floor disorders later in life. Prediction models and scoring systems have been used in other areas of medicine to identify patients who are at risk for chronic diseases. Models have been developed for use before delivery that predict short-term risk of pelvic floor disorders after childbirth, but no models that predict long-term risk exist., Objective: The purpose of this study was to use variables that are known before and during childbirth to develop and validate prognostic models that will estimate the risks of these disorders 12 and 20 years after delivery., Study Design: Obstetric variables were collected from 2 cohorts: (1) women who gave birth in the United Kingdom and New Zealand (n=3763) and (2) women from the Swedish Medical Birth Register (n=4991). Pelvic floor disorders were self-reported 12 years after childbirth in the United Kingdom/New Zealand cohort and 20 years after childbirth in the Swedish Register. The cohorts were split so that data during the first half of the cohort's time period were used to fit prediction models, and validation was performed from the second half (temporal validation). Because there is currently no consensus on how to best define pelvic floor disorders from a patient's perspective, we chose to fit the data for each model using multiple outcome definitions for prolapse, urinary incontinence, fecal incontinence, ≥1 pelvic floor disorder, and ≥2 pelvic floor disorders. Model accuracy was measured in the following manner: (1) by ranking an individual's risk among all subjects in the cohort (discrimination) with the use of a concordance index and (2) by observing whether the predicted probability was too high or low (calibration) at a range of predicted probabilities with the use of visual plots., Results: Models were able to discriminate between women who experienced bothersome symptoms or received treatment at 12 and 20 years, respectively, for pelvic organ prolapse (concordance indices, 0.570, 0.627), urinary incontinence (concordance indices, 0.653, 0.689), fecal incontinence (concordance indices, 0.618, 0.676), ≥1 pelvic floor disorders (concordance indices, 0.639, 0.675), and ≥2 pelvic floor disorders (concordance indices, 0.635, 0.619). Route of delivery and family history of each pelvic floor disorder were strong predictors in most models. Urinary incontinence before and during the index pregnancy was a strong predictor for the development of all pelvic floor disorders in most models 12 years after delivery. The 12- and 20-year bothersome symptoms or treatment for prolapse models were accurate when predictions were provided for risk from 0% to approximately 15%. The 12- and 20-year primiparous model began to over predict when risk rates reached 20%. When we predicted bothersome symptoms or treatment for urinary incontinence, the 12-year models were accurate when predictions ranged from approximately 5-60%; the 20-year primiparous models were accurate from 5% and 80%. For bothersome symptoms or treatment for fecal incontinence, the 12- and 20-year models were accurate from 1-15% risk and began to over predict at rates at >15% and 20%, respectively., Conclusion: Models may provide an opportunity before birth to identify women who are at low risk of the development of pelvic floor disorders and may provide institute prevention strategies such as pelvic floor muscle training, weight control, or elective cesarean section for women who are at higher risk. Models are provided at http://riskcalc.org/UR&#95;CHOICE/., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: There is growing interest in uterine conservation at the time of surgery for uterovaginal prolapse, but limited data compare different types of hysteropexy., Objective: We sought to compare 1-year efficacy and safety of laparoscopic sacral hysteropexy and vaginal mesh hysteropexy., Study Design: This multicenter, prospective parallel cohort study compared laparoscopic sacral hysteropexy to vaginal mesh hysteropexy at 8 institutions. We included women ages 35-80 years who desired uterine conservation, were done with childbearing, and were undergoing 1 of the above procedures for stage 2-4 symptomatic anterior/apical uterovaginal prolapse (anterior descent at or beyond the hymen [Aa or Ba ≥ 0] and apical descent at or below the midvagina [C ≥ -TVL/2]). We excluded women with cervical elongation, prior mesh prolapse repair, cervical dysplasia, chronic pelvic pain, uterine abnormalities, and abnormal bleeding. Cure was defined as no prolapse beyond the hymen and cervix above midvagina (anatomic), no vaginal bulge sensation (symptomatic), and no reoperations. Pelvic Organ Prolapse Quantification examination and validated questionnaires were collected at baseline and 12 months including the Pelvic Floor Distress Inventory Short Form, Female Sexual Function Index, and Patient Global Impression of Improvement. In all, 72 subjects/group were required to detect 94% vs 75% cure (80% power, 15% dropout). Intention-to-treat analysis was used with logistic regression adjusting for baseline differences., Results: We performed 74 laparoscopic sacral hysteropexy and 76 vaginal mesh hysteropexy procedures from July 2011 through May 2014. Laparoscopic patients were younger (P < .001), had lower parity (P = .006), were more likely premenopausal (P = .008), and had more severe prolapse (P = .02). Laparoscopic procedure (174 vs 64 minutes, P < .0001) and total operating time (239 vs 112 minutes, P < .0001) were longer. There were no differences in blood loss, complications, and hospital stay. One-year outcomes for the available 83% laparoscopic and 80% vaginal hysteropexy patients revealed no differences in anatomic (77% vs 80%; adjusted odds ratio, 0.48; P = .20), symptomatic (90% vs 95%; adjusted odds ratio, 0.40; P = .22), or composite (72% vs 74%; adjusted odds ratio, 0.58; P = .27) cure. Mesh exposures occurred in 2.7% laparoscopic vs 6.6% vaginal hysteropexy (P = .44). A total of 95% of each group were very much better or much better. Pelvic floor symptom and sexual function scores improved for both groups with no difference between groups., Conclusion: Laparoscopic sacral hysteropexy and vaginal mesh hysteropexy had similar 1-year cure rates and high satisfaction., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Depression has been associated with symptom amplification, functional impairment, and lower incontinence-specific quality of life in women with urinary incontinence. Although depression has been shown to impact both subjective and objective outcomes after many different surgeries, there are limited data on the effects of major depression on postoperative outcomes after antiincontinence surgery., Objective: The purpose of this study was to determine whether major depression affects urinary incontinence severity and quality of life after midurethral sling surgery., Study Design: This was a secondary analysis of the Trial of Midurethral Slings. Participants were assigned randomly either to a retropubic or transobturator sling for stress urinary incontinence. Each was classified as having major depression or not by the validated depression screening Patient Health Questionnaire-9. Pre- and postoperative urinary incontinence severity (which was assessed by the International Consultation on Incontinence Questionnaire), urinary incontinence-specific quality of life (which was assessed by the Incontinence Impact Questionnaire and the Urinary Distress Inventory), and sexual function (which was assessed by the Prolapse/Urinary Incontinence Sexual Questionnaire) was compared between groups at baseline and at 12 months., Results: Five hundred twenty-six patients were included: 79 patients (15%) had major depression before surgery; 447 patients (85%) did not. Baseline incontinence severity was higher in women with major depression than in those without (International Consultation on Incontinence Questionnaire, 14.7 ± 4.1 vs 12.9 ± 4.0; P < .001). Similarly, baseline quality of life and sexual function were worse in depressed women than in nondepressed women (Incontinence Impact Questionnaire, 235.6 ± 95.8 vs 134.8 ± 89.8; P < .001; Urinary Distress Inventory, 162.7 ± 46 vs 128.6 ± 41.3; P < .001; and Prolapse/Urinary Incontinence Sexual Questionnaire-12, 27.2 ± 7.3 vs 33.9 ± 6.4; P < .001). After adjustment for differences between groups, baseline major depression did not negatively affect 12-month incontinence severity or quality of life. However, at 12 months after surgery, despite significant improvement in sexual function scores in depressed women, the 12-month scores were still significantly worse in the major depression group (Prolapse/Urinary Incontinence Sexual Questionnaire-12, 34.1 ± 7.1 vs 37.7 ± 6.1; P < .001); multivariable analysis showed independent association of baseline major depression with 12-month sexual function. At 12 months, 83% of those women (66/79) with baseline major depression were no longer depressed., Conclusion: Women with major depression who are planning surgery for stress urinary incontinence have worse quality of life than nondepressed women. However, women with major depression improve significantly more than those without major depression such that, at 12 months postoperatively, incontinence severity and quality of life are not different between groups. Sexual function is worse before and after the operation for depressed women., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Intravenous indigo carmine has routinely been used to confirm ureteral patency after urogynecologic surgery. Recent discontinuation of the dye has altered clinical practice. In the absence of indigo carmine, we have used 10% dextrose in sterile water (D10) as cystoscopic fluid to evaluate ureteral patency. Glucosuria has been associated with urinary tract infection (UTI) in vivo and significantly enhanced bacterial growth in vitro. The concern is that the use of D10 would mimic a state of glucosuria albeit transient and increase the risk of postoperative UTI., Objectives: The objectives of this study were to compare the rates of postoperative UTI and lower urinary tract (LUT) injuries between patients who underwent instillation of D10 vs normal saline at the time of intraoperative cystoscopy after urogynecological surgery., Study Design: This was a retrospective cohort study of all women who underwent cystoscopic evaluation of ureteral patency at the time of urogynecological surgery from May through December 2014 at a tertiary care referral center. We compared patients who received D10 cystoscopy fluid vs those who used normal saline. Outcomes included UTI and diagnosis of ureteral or LUT injuries. UTI was diagnosed according to Centers for Disease Control and Prevention guidelines by symptoms alone, urine dipstick, urinalysis, or urine culture. Descriptive statistics compared the rates of UTI between the 2 groups, and a multivariable model was fit to the data to control for potential confounders and significant baseline differences between the groups., Results: A total of 303 women were included. D10 was used in 113 cases and normal saline (NS) was used in 190. The rate of UTI was higher in the D10 group than the NS group: 47.8% (95% confidence interval [CI], 38.3-57.4) vs 25.9% (95% CI, 19.8-32.8, P < .001). After adjusting for age, pelvic organ prolapse stage, use of perioperative estrogen, days of postoperative catheterization, menopausal status, diabetes mellitus, and history of recurrent UTI, the UTI rate remained significantly higher with the use of D10 (adjusted odds ratio, 3.4 [95% CI, 1.6-7.5], P = .002) compared with NS. Overall, 3 cases of transient ureteral kinking (1.0%) and one cystotomy (0.3%) were identified intraoperatively. However, ureteral and LUT injuries were not different between groups. No unidentified injuries presented postoperatively., Conclusion: Although the use of D10 cystoscopy fluid has been successful in identifying ureteral patency in the absence of indigo carmine, it is associated with an increased rate of postoperative UTI compared with NS., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to characterize the urinary microbiota in women who are planning treatment for urgency urinary incontinence and to describe clinical associations with urinary symptoms, urinary tract infection, and treatment outcomes., Study Design: Catheterized urine samples were collected from multisite randomized trial participants who had no clinical evidence of urinary tract infection; 16S ribosomal RNA gene sequencing was used to dichotomize participants as either DNA sequence-positive or sequence-negative. Associations with demographics, urinary symptoms, urinary tract infection risk, and treatment outcomes were determined. In sequence-positive samples, microbiotas were characterized on the basis of their dominant microorganisms., Results: More than one-half (51.1%; 93/182) of the participants' urine samples were sequence-positive. Sequence-positive participants were younger (55.8 vs 61.3 years old; P = .0007), had a higher body mass index (33.7 vs 30.1 kg/m(2); P = .0009), had a higher mean baseline daily urgency urinary incontinence episodes (5.7 vs 4.2 episodes; P < .0001), responded better to treatment (decrease in urgency urinary incontinence episodes, -4.4 vs -3.3; P = .0013), and were less likely to experience urinary tract infection (9% vs 27%; P = .0011). In sequence-positive samples, 8 major bacterial clusters were identified; 7 clusters were dominated not only by a single genus, most commonly Lactobacillus (45%) or Gardnerella (17%), but also by other taxa (25%). The remaining cluster had no dominant genus (13%)., Conclusion: DNA sequencing confirmed urinary bacterial DNA in many women with urgency urinary incontinence who had no signs of infection. Sequence status was associated with baseline urgency urinary incontinence episodes, treatment response, and posttreatment urinary tract infection risk., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The goals of this trial are to determine the efficacy and safety of two treatments for women experiencing fecal incontinence. First, we aim to compare the use of loperamide to placebo and second, to compare the use of anal sphincter exercises with biofeedback to usual care. The primary outcome is the change from baseline in the St. Mark's (Vaizey) Score 24weeks after treatment initiation. As a Pelvic Floor Disorders Network (PFDN) trial, subjects are enrolling from eight PFDN clinical centers across the United States. A centralized data coordinating center supervises data collection and analysis. These two first-line treatments for fecal incontinence are being investigated simultaneously using a two-by-two randomized factorial design: a medication intervention (loperamide versus placebo) and a pelvic floor strength and sensory training intervention (anal sphincter exercises with manometry-assisted biofeedback versus usual care using an educational pamphlet). Interventionists providing the anal sphincter exercise training with biofeedback have received standardized training and assessment. Symptom severity, diary, standardized anorectal manometry and health-related quality of life outcomes are assessed using validated instruments administered by researchers masked to randomized interventions. Cost effectiveness analyses will be performed using prospectively collected data on care costs and resource utilization. This article describes the rationale and design of this randomized trial, focusing on specific research concepts of interest to researchers in the field of female pelvic floor disorders and all other providers who care for patients with fecal incontinence., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to compare the backfill standard voiding trial (SVT) that relies on the assessment of voided volume to subjective patients' evaluation of their voiding based on the assessment of the force of stream (FOS) after an outpatient midurethral sling surgery., Study Design: This double-blinded randomized trial included patients undergoing an outpatient midurethral sling surgery without any other concomitant surgery. Participants were randomized to either the SVT group or to the FOS group. The primary outcome was the rate of catheterization any time up to 6 weeks after surgery. Both groups underwent the same backfill voiding trial protocol postoperatively. Measurements of the voided amount, postvoid residual, and the response to the FOS visual analog scale were collected. The criteria for passing the voiding trial in the SVT group was voiding at least two-thirds of the instilled amount; while the criteria for passing the trial in the FOS group was assessment of FOS at least 50% of the baseline, regardless of the voided volume. Participants were interviewed preoperatively and 2-4 days, 7-9 days, and 6 weeks postoperatively. All postoperative interviews included assessments of pain, tolerance of physical activity, urinary FOS, as well as satisfaction with the surgery. Validated questionnaires (Incontinence Severity Index and Urinary Distress Inventory, short form) before the surgery and 6 weeks after were used to evaluate urinary symptoms., Results: A total of 108 patients were enrolled and randomized, and 6-week follow-up data were available for 102 participants (FOS 50, SVT 52). The 2 groups were similar with respect to demographic characteristics and urinary symptoms. The incidence of catheterization was also similar between the groups (FOS 13 [26%], SVT 13 [25.5%]; P=.95). Amount voided had a moderate correlation with FOS assessment (Spearman rho 0.5; P<.001). There was no significant difference in mean catheter days, pain scores, Incontinence Severity Index, and Urinary Distress Inventory, short form scores between the 2 groups. Of the patients who were discharged home without a catheter in either group none required catheter reinsertion within 6 weeks after the surgery., Conclusion: Patient's subjective assessment of the urinary FOS correlated well with the measured voided amount and no difference in catheterization days was noted between the subjective and objective assessment of voiding. Thus subjective evaluation of the FOS is a reliable and safe method to use after outpatient midurethral surgery., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: We sought to describe perioperative and postoperative adverse events associated with uterosacral colpopexy, to describe the rate of recurrent pelvic organ prolapse (POP) associated with uterosacral colpopexy, and to determine whether surgeon technique and suture choice are associated with these rates., Study Design: This was a retrospective chart review of women who underwent uterosacral colpopexy for POP from January 2006 through December 2011 at a single tertiary care center. The electronic medical record was queried for demographic, intraoperative, and postoperative data. Strict definitions were used for all clinically relevant adverse events. Recurrent POP was defined as the following: symptomatic vaginal bulge, prolapse to or beyond the hymen, or any retreatment for POP., Results: In all, 983 subjects met study inclusion criteria. The overall adverse event rate was 31.2% (95% confidence interval [CI], 29.2-38.6), which included 20.3% (95% CI, 17.9-23.6) of subjects with postoperative urinary tract infections. Of all adverse events, 3.4% were attributed to a preexisting medical condition, while all other events were ascribed to the surgical intervention. Vaginal hysterectomy, age, and operative time were not significantly associated with any adverse event. The intraoperative bladder injury rate was 1% (95% CI, 0.6-1.9) and there were no intraoperative ureteral injuries; 4.5% (95% CI, 3.4-6.0) of cases were complicated by ureteral kinking requiring suture removal. The rates of pulmonary and cardiac complications were 2.3% (95% CI, 1.6-3.5) and 0.8% (95% CI, 0.4-1.6); and the rates of postoperative ileus and small bowel obstruction were 0.1% (95% CI, 0.02-0.6) and 0.8% (95% CI, 0.4-1.6). The composite recurrent POP rate was 14.4% (95% CI, 12.4-16.8): 10.6% (95% CI, 8.8-12.7) of patients experienced vaginal bulge symptoms, 11% (95% CI, 9.2-13.1) presented with prolapse to or beyond the hymen, and 3.4% (95% CI, 2.4-4.7) required retreatment. Number and type of suture used were not associated with a higher rate of recurrence. Of the subjects who required unilateral removal of sutures to resolve ureteral kinking, 63.6% did not undergo suture replacement; this was not associated with a higher rate of POP recurrence., Conclusion: Perioperative and postoperative complication rates associated with severe morbidity after uterosacral colpopexy appear to be low. Uterosacral colpopexy remains a safe option for the treatment of vaginal vault prolapse., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The randomized controlled trial (RCT) is designed to measure the efficacy of an intervention and is considered to be the most rigorous form of research, allowing for causal inferences to be made between treatments and outcomes. When designing an RCT, one must consider its essential methodological components including randomization, allocation, blinding, choice of outcome measures, sample size, loss to follow-up, and crossover. In contrast to RCTs of medical therapy, surgical trials face unique challenges that can affect study design, implementation, and interpretation of results. However, there are strategies that researchers can use to try to mitigate many of these challenges to improve the validity of the study. In addition, there are unique ethical considerations that must be examined when designing surgical trials, and steps must be taken to acknowledge them while maintaining the integrity of the study design. RCTs remain the best design to evaluate the efficacy of novel surgical treatments; however, researchers should be aware of and address the unique challenges inherent to surgical trials., (Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.)

Introduction: The use of acellular dermal matrix (ADM) has transformed the technique of implant-based breast reconstruction. It offers the option of a one-stage procedure and is felt to have benefits in cosmetic outcome but the medium and long-term outcomes are unknown., Methods: All cases where ADM was used in a breast reconstructive procedure in the Edinburgh Breast Unit from its initial use on 7/7/2008 to 31/7/2012 were reviewed retrospectively. Follow up was completed to 30/11/2012., Results: 147 patients received 232 sheets of ADM (156 Strattice, 73 Permacol and 3 Alloderm). Mean follow up was 687 days. In 40 cases unplanned implant explantation occurred (17.2% or 27.2% of patients). 7 of 27 (25.9%) patients requiring adjuvant therapy had this delayed due to problems with the reconstruction. 30 of 80 patients (37.5%) undergoing unilateral surgery have undergone contralateral surgery. Implant loss varied significantly with smoking (34.6% loss rate in smokers vs 13.2% in non-smokers, p = 0.001), with radiotherapy (28.1% loss rate vs 13.8% with no radiotherapy, p = 0.001) and with incision type. There was no statistically significant variation by operating surgeon, type of ADM used, chemotherapy use, patient weight, breast weight or nipple preservation. Patients underwent a mean of 1.54 further operations (range 0-7)., Conclusions: While offering potential cosmetic and financial benefits, the use of ADM with implant-based reconstructions has a significant rate of implant loss, further surgery and potential delay in adjuvant therapy. These must be considered when planning treatment and consenting patients., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Objective: Our first objective was to compare peri- and postoperative adverse events between robotic-assisted laparoscopic sacrocolpopexy (RSC) and conventional laparoscopic sacrocolpopexy (LSC) in a cohort of women who underwent these procedures at a tertiary care center. Our second objective was to explore whether hysterectomy and rectopexy at the time of sacrocolpopexy were associated with these adverse events., Study Design: This was a retrospective cohort study of women who underwent either RSC or LSC with or without concomitant hysterectomy and/or rectopexy from 2006-2012. Once patients were identified as either having undergone RSC or LSC, the electronic medical record was queried for demographic, peri-, and postoperative data., Results: Four hundred six women met study inclusion criteria. Mean age and body mass index of all the women were 58 ± 10 years and 27.9 ± 4.9 kg/m(2). The women who underwent RSC were older (60 ± 9 vs 57 ± 10 years, respectively; P = .009) and more likely to be postmenopausal (90.9% vs 79.1%, respectively; P = .05). RSC cases were associated with a higher intraoperative bladder injury rate (3.3% vs 0.4%, respectively; P = .04), a higher rate of estimated blood loss of ≥500 mL (2.5% vs 0, respectively; P = .01), and reoperation rate for pelvic organ prolapse (4.9% vs 1.1%, respectively; P = .02) compared with LSC. Concomitant rectopexy was associated with a higher risk of transfusion (2.8% vs 0.3%, respectively; P = .04), pelvic/abdominal abscess formation (11.1% vs 0.8%, respectively; P < .001), and osteomyelitis (5.6% vs 0, respectively; P < .001). The mesh erosion rate for all the women was 2.7% and was not statistically different between LSC and RSC and for patients who underwent concomitant hysterectomy and those who did not., Conclusion: Peri- and postoperative outcomes after RSC and LSC are favorable, with few adverse outcomes. RSC is associated with a higher rate of bladder injury, estimated blood loss ≥500 mL, and reoperation for recurrent pelvic organ prolapse; otherwise, the rate of adverse events is similar between the 2 modalities. Concomitant rectopexy is associated with a higher rate of postoperative abscess and osteomyelitis complications., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Study Objective: To develop a valid laparoscopic sacrocolpopexy simulation model for use as an assessment and learning tool for performing this procedure., Design: Simulation study (Canadian Task Force classification II-2)., Setting: Two tertiary academic centers., Intervention: A training model was developed to simulate performance of a laparoscopic sacrocolpopexy. Construct validity was measured by comparing observed masked performances on the model between experienced Female Pelvic Medicine and Reconstructive Surgeons (experts) and upper level trainees. All videotaped performances were scored by 2 surgeons who were masked to subject identity and using the valid and reliable Global Operative Assessment of Laparoscopic Skills scale., Measurements and Main Results: The expert group included Female Pelvic Medicine and Reconstructive Surgeons (n = 5) experienced in laparoscopic sacrocolpopexy, and the trainee group (n = 15) included fourth-year gynecology residents (n = 5) and fellows in Female Pelvic Medicine and Reconstructive Surgery and in Minimally Invasive Gynecologic Surgery (n = 10). The experts performed significantly better than the trainees in total score and in every domain of the Global Operative Assessment of Laparoscopic Skills scale (median [range] score: expert group, 33 [30.5-39] vs. trainee group, 20.5 [13.5-30.5]; p = .002). Previous surgical experience had a strong association with performance on the model (rho > 0.75). Most subjects "agreed" or "strongly agreed" that the model was authentic to the live procedure and a useful training tool. There was strong agreement between masked raters (interclass correlation coefficient 0.84)., Conclusion: This simulation model is valid and reliable for assessing performance of laparoscopic sacrocolpopexy and may be used for practicing key steps of the procedure., (Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to describe the evaluation and management of synthetic mesh-related complications after surgery for stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP)., Study Design: We conducted a multicenter, retrospective analysis of women who attended 4 US tertiary referral centers for evaluation of mesh-related complications after surgery for SUI and/or POP from January 2006 to December 2010. Demographic, clinical, and surgical data were abstracted from the medical record, and complications were classified according to the Expanded Accordion Severity Classification., Results: Three hundred forty-seven patients sought management of synthetic mesh-related complications over the study period. Index surgeries were performed for the following indications: SUI (sling only), 49.9%; POP (transvaginal mesh [TVM] or sacrocolpopexy only), 25.6%; and SUI + POP (sling + TVM or sacrocolpopexy), 24.2%. Median time to evaluation was 5.8 months (range, 0-65.2). Thirty percent of the patients had dyspareunia; 42.7% of the patients had mesh erosion; and 34.6% of the patients had pelvic pain. Seventy-seven percent of the patients had a grade 3 or 4 (severe) complication. Patients with TVM or sacrocolpopexy were more likely to have mesh erosion and vaginal symptoms compared with sling only. The median number of treatments for mesh complications was 2 (range, 1-9); 60% of the women required ≥2 interventions. Initial treatment intervention was surgical for 49% of subjects. Of those treatments that initially were managed nonsurgically, 59.3% went on to surgical intervention., Conclusion: Most of the women who seek management of synthetic mesh complication after POP or SUI surgery have severe complications that require surgical intervention; a significant proportion require >1 surgical procedure. The pattern of complaints differs by index procedure., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Objective: We sought to determine the frequency of laboratory studies after female pelvic reconstructive surgery and the rate of intervention based on the results of these laboratory values at a single institution., Study Design: We conducted a retrospective review of all patients undergoing female pelvic reconstructive surgery for pelvic organ prolapse by 5 fellowship-trained pelvic reconstructive surgeons at a single institution from Jan. 1, 2010, through Dec. 31, 2010. Exclusion criteria were outpatient procedures, isolated hysterectomy, and a combined surgery with another surgical team performing a separate procedure. Interventions based on the number of laboratory studies were classified as minor (electrolyte repletion, repeat laboratory tests, initiation of antibiotics) or major (transfusion, delayed discharge)., Results: A total of 356 patients were included in the final dataset and 100% of patients had routine postoperative laboratory studies. A total of 8771 laboratory values were obtained with a mean of 25 ± 18 laboratory values (0-133) per patient. One-third of postoperative patients (n = 120) underwent a total of 207 interventions based on abnormal laboratory results. The majority of interventions were minor (96%). Of the 120 patients who had a minor intervention, electrolyte repletion was the most common (78%), followed by repeat blood collection (40%) and initiation of antibiotics (4%). The major intervention rate was 4% (n = 8) and all underwent transfusion. Of the 8 transfused patients, 7 demonstrated clinical instability before transfusion and 1 was transfused based on laboratory values and a significant cardiac history., Conclusion: Routine postoperative laboratory studies are not necessary for all patients after female pelvic reconstructive surgery and more judicious use based on clinical findings may limit unnecessary minor interventions., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Objective: The purpose of this study was to compare operative time and intra- and postoperative complications between total laparoscopic hysterectomy and robotic-assisted total laparoscopic hysterectomy., Study Design: This study was a blinded, prospective randomized controlled trial conducted at 2 institutions. Subjects consisted of women who planned laparoscopic hysterectomy for benign indications. Preoperative randomization to total laparoscopic hysterectomy or robotic-assisted total laparoscopic hysterectomy was stratified by surgeon and uterine size (> or ≤12 weeks). Validated questionnaires, activity assessment scales, and visual analogue scales were administered at baseline and during follow-up evaluation., Results: Sixty-two women gave consent and were enrolled and randomly assigned; 53 women underwent surgery (laparoscopic, 27 women; robot-assisted, 26 women). There were no demographic differences between groups. Compared with laparoscopic hysterectomy, total case time (skin incision to skin closure) was significantly longer in the robot-assisted group (mean difference, +77 minutes; 95% confidence interval, 33-121; P < .001] as was total operating room time (entry into operating room to exit; mean difference, +72 minutes; 95% confidence interval, 14-130; P = .016). Mean docking time was 6 ± 4 minutes. There were no significant differences between groups in estimated blood loss, pre- and postoperative hematocrit change, and length of stay. There were very few complications, with no difference in individual complication types or total complications between groups. Postoperative pain and return to daily activities were no different between groups., Conclusion: Although laparoscopic and robotic-assisted hysterectomies are safe approaches to hysterectomy, robotic-assisted hysterectomy requires a significantly longer operative time., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Objective: The purpose of this study was to estimate the incidence of postoperative pulmonary complications after hysterectomy for benign indications., Study Design: This was a retrospective cohort study of all women who underwent hysterectomy for benign indications at the Cleveland Clinic from Jan. 1, 2001, to Dec. 31, 2009. Exclusion criteria incorporated patients who underwent hysterectomy for premalignant or malignant conditions. Pulmonary complications were defined as postoperative pneumonia, respiratory failure, atelectasis, and pneumothorax based on International classification of diseases, ninth revision, codes., Results: In the 9-year study period, 3226 women underwent hysterectomy for benign indications (abdominal, 38.4%; vaginal, 39.3%; laparoscopic, 22.3%). Ten of the 3226 women (0.3%; 95% confidence interval, 0.17-0.57%) who underwent hysterectomy were identified with postoperative pulmonary complications. Among the different types of hysterectomy, the incidence of pulmonary complications was not different (total abdominal hysterectomy, 0.9%; vaginal hysterectomy, 0.12%; laparoscopic hysterectomy, 0.9%; P = .8)., Conclusion: The incidence of postoperative pulmonary complications after hysterectomy for benign indications is low., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Objective: The purpose of this study was to develop and test a unique, new pelvic floor surgery complication scale and compare it with an existing validated measure., Study Design: Surgeons from 2 clinical trials networks rated complications based on perceived patient bother, severity, and duration of disability to develop a pelvic floor complication scale (PFCS). PFCS scores were calculated for subjects in 2 multicenter pelvic floor surgical trials. The PFCS and modified Clavien-Dindo scores were evaluated for associations with length of hospitalization, satisfaction, and quality-of-life measures (health utilities index, short form-36, urogenital distress inventory, and incontinence impact questionnaire)., Results: We calculated PFCS scores for 977 subjects. Higher PFCS and Clavien-Dindo scores similarly were associated with longer length of hospitalization (P < .01), lower satisfaction (P < .01), lower Health Utilities Index scores (P = .02), lower short form-36 scores (P = .02), higher urogenital distress Inventory scores (P < .01), and incontinence impact questionnaire scores (P < .01) at 3 months. No associations were present at 1 year., Conclusion: The PFCS compares favorably to the validated modified Clavien-Dindo instrument., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Purpose: The purpose of the study was to develop a model that predicts an individual applicant's probability of successful placement into a surgical subspecialty fellowship program., Methods: Candidates who applied to surgical fellowships during a 3-year period were identified in a set of databases that included the electronic application materials., Results: Of the 1281 applicants who were available for analysis, 951 applicants (74%) successfully placed into a colon and rectal surgery, thoracic surgery, vascular surgery, or pediatric surgery fellowship. The optimal final prediction model, which was based on a logistic regression, included 14 variables. This model, with a c statistic of 0.74, allowed for the determination of a useful estimate of the probability of placement for an individual candidate., Conclusions: Of the factors that are available at the time of fellowship application, 14 were used to predict accurately the proportion of applicants who will successfully gain a fellowship position., (Copyright © 2012 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: We sought to assess interrater reliability of the International Continence Society (ICS)/International Urogynecological Association (IUGA) classification system of vaginal mesh-related complications and compare this with several other available complication classification systems., Study Design: This was a retrospective analysis of mesh-related complications in patients presenting after pelvic organ prolapse or incontinence surgery. The complications were classified by 2 independent reviewers using the ICS/IUGA classification system as well as 3 other available classification systems. Interrater reliability was assessed using percent agreement and the weighted κ statistic., Results: The ICS/IUGA mesh complication classification system was found to have poor interrater reliability (κ = 0.15-0.78). The other systems yielded a κ that ranged from 0.18-0.60, but were too general or could only be applied to 68% of the complications., Conclusion: The complexity of the ICS/IUGA mesh complication system, the large number of categories, and lack of clarity likely contribute to its poor interrater reliability., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Objective: To determine whether the tissue model onto which a knot is tied influences the knot's tensile strength., Study Design: Zero-gauge, nonexpired, silk, polyglactin 910, polydioxanone, and polypropylene sutures were tied on 4 different mock tissue models. The tissue models were standard metal hex head screw, uncooked chicken breast, a tube of packaged "string" cheese, and a cylinder of bubble wrap. The knots were tied without a surgeon's knot and with 4 additional square knots (1 = 1 = 1 = 1 = 1). The knots were tied by a single obstetrician/gynecologist investigator (J.M.D.) over the period of 1 week to minimize fatigue. We compared the knots when subjected to a tensiometer until the suture broke or untied. A minimum of 20 knots per group were needed to detect a moderate effect size with a power of 85% and a type I error rate of 5%., Results: A total of 407 knots were tied with 4 types of material (silk, polyglactin 910, polydioxanone, and polypropylene), using 4 different models (chicken, bubble wrap, cheese, and metal). Among the knot failures, 113 of 407 untied rather than broke (28%). No differences in the likelihood of knots coming untied between the different models (p = 0.34) or tension at failure (p = 0.81) were noted. A 4 × 4 factorial analysis of variance (ANOVA) was conducted to determine the effects of the suture material and model type on tension at failure and whether there was any interaction between the 2 factors. No significant difference was observed in the interaction between suture material and model type (p = 0.35), and no effect for model type was found (p = 0.22)., Conclusions: Tissue models that use materials more similar to human tissue do not seem to influence knot strength when compared with standard metal models. We propose that it is possible to have an accurate understanding of how knots withstand force and to simulate an in vivo environment by using low-cost, easily accessible natural and synthetic materials for the mechanism onto which the knot is tied., (Copyright © 2012 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to reanalyze the results of a previously published trial that compared 3 methods of anterior colporrhaphy according to the clinically relevant definitions of success., Study Design: A secondary analysis of a trial of 114 subjects who underwent surgery for anterior pelvic organ prolapse who were assigned randomly to standard anterior colporrhaphy, ultralateral colporrhaphy, or anterior colporrhaphy plus polyglactin 910 mesh from 1996-1999. For the current analysis, success was defined as (1) no prolapse beyond the hymen, (2) the absence of prolapse symptoms (visual analog scale ≤ 2), and (3) the absence of retreatment., Results: Eighty-eight percent of the women met our definition of success at 1 year. One subject (1%) underwent surgery for recurrence 29 months after surgery. No differences among the 3 groups were noted for any outcomes., Conclusion: Reanalysis of a trial of 3 methods of anterior colporrhaphy revealed considerably better success with the use of clinically relevant outcome criteria compared with strict anatomic criteria., (Copyright © 2011 Mosby, Inc. All rights reserved.)

Objective: The objective of the study was to compare the relative frequencies of pain in women with and without pelvic organ prolapse (POP)., Study Design: This was an ancillary analysis of a case-control study investigating functional bowel disorders in women with and without POP. Cases were defined as subjects with stage 3 or 4 POP and controls were subjects with normal pelvic support., Results: Women with POP were more likely to experience lower abdominal or pelvic pain that was significantly bothersome and interfered with daily activities (odds ratio [OR], 9.7; 95% confidence interval [CI], 4.7-20.4). After controlling for confounders, women with prolapse were more likely to report pressure in the lower abdomen (OR, 2.3; 95% CI, 1.6-3.2), heaviness in the pelvic region (OR, 3.3; 95% CI, 2.3-4.3), and pain in the lower abdomen (OR, 2.6; 95% CI, 1.8-4.1)., Conclusion: Women with prolapse are more likely to report pain, pressure, or heaviness in the lower abdomen or pelvis compared with women with normal support., (Copyright © 2011 Mosby, Inc. All rights reserved.)

Objectives: (1) To systematically collect and organize into clinical categories all outcomes reported in trials for abnormal uterine bleeding (AUB); (2) to rank the importance of outcomes for patient decision making; and (3) to improve future comparisons of effects in trials of AUB interventions., Study Design and Setting: Systematic review of English-language randomized controlled trials of AUB treatments in MEDLINE from 1950 to June 2008. All outcomes and definitions were extracted and organized into major outcome categories by an expert group. Each outcome was ranked "critically important," "important," or "not important" for informing patients' choices., Results: One hundred thirteen articles from 79 trials met the criteria. One hundred fourteen different outcomes were identified, only 15 (13%) of which were ranked as critically important and 29 (25%) as important. Outcomes were grouped into eight categories: (1) bleeding; (2) quality of life; (3) pain; (4) sexual health; (5) patient satisfaction; (6) bulk-related complaints; (7) need for subsequent surgical treatment; and (8) adverse events., Conclusion: To improve the quality, consistency, and utility of future AUB trials, we recommend assessing a limited number of clinical outcomes for bleeding, disease-specific quality of life, pain, sexual health, and bulk-related symptoms both before and after treatment and reporting satisfaction and adverse events. Further development of validated patient-based outcome measures and the standardization of outcome reporting are needed., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objective: The purpose of the study was to determine the optimal number of throws to ensure knot security., Study Design: Knots were tied with 3, 4, 5, or 6 square throws with 0-gauge coated polyester, polydioxanone, polypropylene, and polyglactin 910. The suture was soaked in 0.9% sodium chloride and subsequently transferred to a tensiometer and broken., Results: A total of 225 knots were tied. Regardless of the suture type, tension at failure for knots with 4 throws, 5 throws, and 6 throws was higher than tension at failure of knots with only 3 throws (p < 0.05 for each). We found no difference in the tensile strength between knots with 4, 5, or 6 throws (p > 0.05 for each). Knots with 4 throws were significantly more likely to come untied than knots with 5 or 6 throws (p < 0.01)., Conclusions: Under laboratory conditions, the ideal knot has 5 throws to maximize tensile strength and rate of untying. This finding does not seem to vary by type of suture material., (Copyright © 2011 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: This analysis compared 3 continuous variables as summary support loss (SL) scores with pelvic organ prolapse (POP) quantification (POPQ) ordinal stages., Study Design: We used pooled baseline data from 1141 subjects in 3 randomized trials (CARE, n = 322; OPUS, n = 380; ATLAS, n = 439) to test 3 SL measures. The relative responsiveness was assessed using the standardized response mean of 2-year outcome data from the CARE trial., Results: Each SL measure was strongly correlated with POPQ ordinal staging; the single most distal POPQ point had the strongest correlation. Improvements in anatomic support were weakly correlated with improvements in POP Distress Inventory (r = 0.17-0.24; P < .01 for each) but not with changes in POP Impact Questionnaire for all measures of SL or POPQ stage., Conclusion: While continuous, single number summary measures compared favorably to ordinal POPQ staging system, the single most distal POPQ point may be preferable to POPQ ordinal stages to summarize or compare group data., (Copyright © 2010 Mosby, Inc. All rights reserved.)

Objective: We sought to determine the incidence of symptomatic deep venous thrombosis and pulmonary embolism, collectively referred to as venous thromboembolic events (VTE), in patients undergoing urogynecologic surgery to guide development of a VTE prophylaxis policy for this patient population., Study Design: We conducted a retrospective analysis of VTE incidence among women undergoing urogynecologic surgery over a 3-year period. All patients wore sequential compression devices intraoperatively through hospital discharge., Results: Forty of 1104 patients (3.6%) undergoing urogynecologic surgery were evaluated with chest computed tomography, lower extremity ultrasound, or both for suspicion of VTE postoperatively. The overall rate of venous thromboembolism in this population was 0.3% (95% confidence interval, 0.1-0.8)., Conclusion: Most women undergoing incontinence and reconstructive pelvic surgery are at a low risk for VTE. Sequential compression devices appear to provide adequate VTE prophylaxis in this patient population., (Copyright © 2010 Mosby, Inc. All rights reserved.)

Objective: We sought to develop a valid, reliable assessment of intraoperative judgment by residents during gynecologic surgery based on Script Concordance Theory., Study Design: This was a multicenter prospective study involving 5 obstetrics and gynecology residency programs. Surgeons from each site generated case scenarios based on common gynecologic procedures. Construct validity was evaluated by correlating scores to training level, in-service examinations, and surgical skill and experience using a Global Rating Scale of Operative Performance and case volumes., Results: A final test that included 42 case scenarios was administered to 75 residents. Internal consistency (Cronbach alpha = 0.73) and test-retest reliability (Lin correlation coefficient = 0.76) were good. There were significant differences between test scores and training levels (P = .002) and test scores correlated with in-service examination scores (r = 0.38; P = .001). There was no association between test scores and total number of cases or technical skills., Conclusion: The Script Concordance Test appears to be a reliable, valid assessment tool for intraoperative decision-making during gynecologic surgery., (Copyright 2010 Mosby, Inc. All rights reserved.)

Objective: The aim of this study was to establish minimum cutoff scores on intraoperative assessments of surgical skills to determine surgical competence for vaginal hysterectomy., Study Design: Two surgical rating scales, the Global Rating Scale of Operative Performance and the Vaginal Surgical Skills Index, were used to evaluate trainees while performing vaginal hysterectomy. Cutoff scores were determined using the Modified Angoff method., Results: Two hundred twelve evaluations were analyzed on 76 surgeries performed by 27 trainees. Trainees were considered minimally competent to perform vaginal hysterectomy if total absolute scores (95% confidence interval) on Global Rating Scale = 18 (16.5-20.3) and Vaginal Surgical Skills Index = 32 (27.7-35.5). On average, trainees met new cutoffs after performing 21 and 27 vaginal hysterectomies, respectively. With the new cutoffs applied to the same cohort of fourth-year obstetrics and gynecology trainees, all residents achieved competency in performing vaginal hysterectomy by the end of their gynecology rotations., Conclusion: Standard-setting methods using cutoff scores may be used to establish competence in vaginal surgery., (Copyright (c) 2010 Mosby, Inc. All rights reserved.)

Objective: To develop and validate an instrument to assess surgical skills during vaginal surgery., Study Design: Trainees from 2 institutions were directly assessed in the operating room by supervising surgeons while performing a vaginal hysterectomy using the new Vaginal Surgical Skills Index, global rating scale, and visual analogue scale. Trainees were assessed again by the same surgeons 4 weeks after the live surgery and by a blinded outside reviewer using a videotape of the case. Internal consistency, interrater and intrarater reliability, and construct validity were evaluated., Results: Two hundred twelve evaluations were analyzed on 76 surgeries from 27 trainees. There was good internal consistency, interrater, and intrarater reliability. Vaginal Surgical Skills Index scores correlated with global rating score and visual analog scale scores. Increasing Vaginal Surgical Skills Index scores significantly correlated with year of training and surgical volume with an estimated increase in score of 0.3 per hysterectomy performed., Conclusion: The Vaginal Surgical Skills Index is a feasible, reliable, and valid instrument to assess vaginal surgical skills., (Copyright (c) 2010 Mosby, Inc. All rights reserved.)

Objective: The aim of this study was to assess the risk of unanticipated abnormal gynecologic pathology at the time of reconstructive pelvic surgery to better understand risks of uterine conservation in the surgical treatment of uterovaginal prolapse., Study Design: This was a retrospective analysis of pathology findings at hysterectomy with reconstructive pelvic surgery over a 3.5-year period., Results: Seventeen of 644 patients had unanticipated premalignant or malignant uterine pathology (2.6%; 95% confidence interval, 1.7-4.2). Two (0.3%; 95% confidence interval, 0.09-1.1) had endometrial carcinoma. All cases of unanticipated disease were identified in postmenopausal women., Conclusion: Premenopausal women with uterovaginal prolapse and normal bleeding patterns or with negative evaluation for abnormal uterine bleeding have a minimal risk of abnormal gynecologic pathology. In postmenopausal women without bleeding, the risk of unanticipated uterine pathology is 2.6% but may be reduced by preoperative endometrial evaluation. However, in women with a history of postmenopausal bleeding, even with a negative endometrial evaluation, we do not recommend uterine preservation at the time of prolapse surgery., (Copyright (c) 2010 Mosby, Inc. All rights reserved.)

Objective: The purpose of this study was to determine the incidence and time course of postoperative neuropathy resulting from gynecologic surgery., Study Design: A single cohort of 616 female patients undergoing elective gynecologic surgery for benign or malignant conditions at a tertiary care academic medical center underwent a postoperative neurologic evaluation to identify postoperative neuropathy of the lower extremities., Results: Fourteen peripheral nerve injuries were observed in 11 patients, making the overall incidence of postoperative neuropathy 1.8% (95% confidence interval, 1.0-3.2). Injury to the lateral femoral cutaneous (5), femoral (5), common fibular (1), ilioinguinal/iliohypogastric (1), saphenous (1), and genitofemoral (1) nerves were detected. Complete resolution of neuropathic symptoms occurred in all but 1 patient (91%). Median time to resolution of symptoms was 31.5 days (range, 1 day to 6 months)., Conclusion: The incidence of lower extremity neuropathy attributable to gynecologic operations is low, and these neuropathies resolve in the great majority of cases.

Background: Although an association between obesity and urinary incontinence (UI) has been reported, the association between obesity and other PFDs is less clear. The aim of this study was to determine the prevalence of pelvic floor disorders (PFDs), including stress urinary incontinence (SUI), urge urinary incontinence (UUI), pelvic organ prolapse (POP), and anal incontinence (AI), in obese women contemplating bariatric surgery compared with nonobese subjects at a tertiary care referral hospital., Methods: From September 2006 to December 2007, obese women contemplating bariatric surgery and nonobese women from general gynecology clinic completed a validated screening questionnaire for PFDs, the Sandvik urinary incontinence severity index, and the Rockwood fecal incontinence severity index., Results: A total of 217 obese (mean body mass index of 50 +/- 10 kg/m(2)) and 210 nonobese controls (mean body mass index 23 +/- 3 kg/m(2)) were screened. The presence of any PFD occurred in 159 patients (75%) in the obese group compared with 89 nonobese patients (44%; P <.0001). More obese patients experienced SUI, UUI, and AI, but not POP. Obese patients also had more severe UI and AI. Obesity remained a significant risk factor for UI and AI, even after adjusting for baseline differences in demographics and medical conditions, with an adjusted odds ratio of 4.1 (95% confidence interval 2.3-7.8) and 2.1 (95% confidence interval 1.1-4.1), respectively., Conclusion: The prevalence of PFDs, including SUI, UUI, and all forms of AI, was greater in the obese and morbidly obese women contemplating bariatric surgery. Obesity was also associated with an increased severity of UI and AI. Obesity appears to confer a fourfold and twofold increased risk of UI and AI, respectively.

Objective: We sought to estimate the minimum important difference (MID) for the Urinary Distress Inventory (UDI), UDI-stress subscale of the Pelvic Floor Distress Inventory, and Urinary Impact Questionnaire (UIQ) of the Pelvic Floor Impact Questionnaire., Study Design: We calculated MID using anchor- and distribution-based approaches from a randomized trial for nonsurgical stress incontinence treatment. Anchors included a global impression of change, incontinence episodes from a urinary diary, and the Incontinence Severity Index. Effect size and standard error of measurement were the distribution methods used., Results: Anchor-based MIDs ranged from -22.4 to -6.4 points for the UDI, -16.5 to -4.6 points for the UDI-stress, and -17.0 to -6.5 points for the UIQ. These data were supported by 2 distribution-based estimates., Conclusion: Reasonable estimates of MID are 11, 8, and 16 points for the UDI, UDI-stress subscale, and UIQ, respectively. Statistically significant improvements that meet these thresholds should be considered clinically important.

Objective: We sought to determine the relationship of patient-centered goal achievement in pelvic floor disorder (PFD) treatment to PFD-specific quality-of-life (QOL), depression, health status, and patient satisfaction., Study Design: Ninety women with PFD identified up to 5 goals for treatment and reported their level of goal attainment (-2 to +2) at 1.5, 3, 6, and 12 months; completed the Incontinence Impact Questionnaire, Urogenital Distress Inventory, Incontinence Quality-of-Life Scale, Patient Health Questionnaire, and Short Form-12 Health Survey; and indicated their satisfaction with treatment., Results: Twelve-month mean goal attainment was moderately correlated with PFD-specific measures of QOL (r range, -0.40 to 0.55; P < .05) but less strongly with depression and general health status (r range, -0.27 to 0.28). Twelve-month goal attainment differed significantly among those who were completely satisfied (1.6 +/- 0.5), very satisfied (1.2 +/- 0.6), satisfied (0.4-1.0), or not satisfied (-0.5 +/- 0.9; F = 24.2; P < .01). Earlier follow-up results were similar., Conclusion: PFD treatment goal attainment is associated with improved condition-specific QOL and patient satisfaction.

The primary aims of this trial are: 1) to compare surgical outcomes following sacrospinous ligament fixation to uterosacral vaginal vault suspension in women undergoing vaginal surgery for apical or uterine pelvic organ prolapse and stress urinary incontinence and 2) to examine the effects of a structured perioperative program consisting of behavioral techniques and pelvic floor muscle training compared to usual care. This trial is performed through the Pelvic Floor Disorders Network (PFDN), which is funded by National Institute of Child Health and Human Development. Subjects will be enrolled from hospitals associated with seven PFDN clinical centers across the United States. A centralized biostatistical coordinating center will oversee data collection and analysis. Two approaches will be investigated simultaneously using a 2x2 randomized factorial design: a surgical intervention (sacrospinous ligament fixation versus uterosacral vaginal vault suspension) and a perioperative behavioral intervention (behavioral and pelvic floor muscle training versus usual care). Surgeons have standardized essential components of each surgical procedure and have met specific standards of expertise. Providers of the behavioral intervention have undergone standardized training. Anatomic, functional, and health-related quality of life outcomes will be assessed using validated measures by researchers blinded to all randomization assignments. Cost-effectiveness analysis will be performed using prospectively collected data on health care costs and resource utilization. The primary surgical endpoint is a composite outcome defined by anatomic recurrence, recurrence of bothersome vaginal prolapse symptoms and/or retreatment and will be assessed 2 years after the index surgery. Endpoints for the behavioral intervention include both short-term (6-month) improvement in urinary symptoms and long-term (2-year) improvement in anatomic outcomes and prolapse symptoms. This article describes the rationale and design of this randomized trial, focusing on several key design features of potential interest to researchers in the field of female pelvic floor disorders and others conducting randomized surgical trials.

Objective: The objective of the study was to identify predictors of recurrent urinary incontinence (UI) 1 year after treatment with tension-free vaginal tape (TVT) and transobturator tape (TOT)., Study Design: One hundred sixty-two women with urodynamic stress urinary incontinence (SUI) were included in a clinical trial comparing TVT with TOT with at least 1 year of follow-up were included in this analysis. Potential clinical and urodynamic predictors for development of "any recurrent UI" or "recurrent SUI" 1 year after surgery were evaluated using logistic regression models., Results: Subjects who received concurrent prolapse surgery and those taking anticholinergic medications preoperatively were more likely to develop any recurrent UI. Increasing age was independently associated with recurrent SUI. Risk factors were similar for TVT and TOT for both definitions of treatment failure., Conclusion: Concurrent prolapse surgery and preoperative anticholinergic medication use are associated with increased risk of developing recurrent UI 1 year after TVT or TOT. Increasing age is specifically associated with the recurrence of SUI symptoms.