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Model and compare estimated health system costs and gynecologic practice revenues when hysteroscopic surgery is performed in the office or institutional setting, either an ambulatory surgical center (ASC) or a traditional operating room (OR).Economic modeling exercise.Nonclinical.An economic model was developed that included US reimbursement rates for the office and institutional settings and the inherent expenses required for office hysteroscopic surgery. For Current Procedural Terminology code 58558, hysteroscopic biopsy and/or polypectomy, total health system costs were estimated as follows: office, $1382.48; ASC, $1655.31; OR $2918.10. In the modeled office setting, costs for the same procedure were estimated from instrumentation and supply list prices obtained from vendors and staffing costs from national databases. Revenue and cost modeling were performed and compared both for 1 to 10 monthly procedure volumes and by hysteroscopic systems, whereas other elements of the procedure were standardized, including technique, staffing, generic supplies, and the use of local anesthesia. Four vendors provided system price information: 1 purpose built, 1 electromechanical, and 2 traditional. The projected office-based, per case net revenue with the purpose-built system was always greater than in the ASC or OR and relatively independent of monthly procedure volume (1 per month $743.59; 10 per month $876.17). For the traditional and electromechanical systems, it took from 2 to 5 monthly procedures to realize a net revenue greater than $239.39. Using 3 sets of vendor matched instruments, at 10 cases per month, the per case net revenue for the electromechanical system was $514.00, and for the 2 traditional systems $564.02 and $693.72.Performance of office-based hysteroscopic surgery is associated with reduced health system costs compared with the institutional environment. The net revenue for the practice was dependent on both the volume of procedures performed and the hysteroscopic system and technique selected.

Iron deficiency is a common cause of morbidity and can arise as a consequence or complication from many diseases. The use of intravenous iron has increased significantly in the last decade, but concerns remain about indications and administration. Modern intravenous iron preparations can facilitate rapid iron repletion in one or two doses, both for absolute iron deficiency and, in the presence of inflammation, functional iron deficiency, where oral iron therapy is ineffective or has not worked. A multidisciplinary team of experts experienced in iron deficiency undertook a consensus review to support healthcare professionals with practical advice on managing iron deficiency in gastrointestinal, renal and cardiac disease, as well as; pregnancy, heavy menstrual bleeding, and surgery. We explain how intravenous iron may work where oral iron has not. We provide context on how and when intravenous iron should be administered, and informed opinion on potential benefits balanced with potential side-effects. We propose how intravenous iron side-effects can be anticipated in terms of what they may be and when they may occur. The aim of this consensus is to provide a practical basis for educating and preparing staff and patients on when and how iron infusions can be administered safely and efficiently.Key messagesIron deficiency treatment selection is driven by several factors, including the presence of inflammation, the time available for iron replenishment, and the anticipated risk of side-effects or intolerance.Intravenous iron preparations are indicated for the treatment of iron deficiency when oral preparations are ineffective or cannot be used, and therefore have applicability in a wide range of clinical contexts, including chronic inflammatory conditions, perioperative settings, and disorders associated with chronic blood loss.Adverse events occurring with intravenous iron can be anticipated according to when they typically occur, which provides a basis for educating and preparing staff and patients on how iron infusions can be administered safely and efficiently.

To synthesize the published literature to better understand the association between cesarean scar defects (CSDs) and abnormal uterine bleeding (AUB). In particular, we aimed to evaluate the risk and pattern(s) of CSD-associated AUB in addition to exploring the relationship between defect morphology with bleeding symptoms.Systematic review and meta-analysis.Not applicable.Patients with CSD and reports of uterine bleeding as an outcome were identified in 60 studies from database searches.Studies that investigated CSD (as defined by investigators) and reported uterine bleeding, menstrual bleeding, or AUB as an outcome were included.The prevalence and risk of AUB (intermenstrual, postmenstrual, and unscheduled bleeding) in patients with confirmed CSD.Nine studies reported on the prevalence of AUB in patients with a confirmed CSD. Patients with CSD were more likely to experience AUB, compared with those without CSD (relative risk, 3.47; 95% confidence interval [CI], 2.02-5.97; 6 studies, 1,385 patients; IThere is a strong and consistent association between patients with CSD and AUB. These patients experience a unique bleeding pattern, namely prolonged menstruation and early-cycle intermenstrual bleeding. These data should provide impetus for including CSD as a distinct entity in AUB classification systems. High heterogeneity in our results calls for standardization of nomenclature and outcome reporting for this condition.

Structured laparoscopic and hysteroscopic manual skills testing distinguished novice from mid-level residents, and board-certified obstetrician–gynecologists from fellowship-trained minimally invasive gynecologic surgeons., OBJECTIVE: To establish validity evidence for the Essentials in Minimally Invasive Gynecology laparoscopic and hysteroscopic simulation systems. METHODS: A prospective cohort study was IRB approved and conducted at 15 sites in the United States and Canada. The four participant cohorts based on training status were: 1) novice (postgraduate year [PGY]-1) residents, 2) mid-level (PGY-3) residents, 3) proficient (American Board of Obstetrics and Gynecology [ABOG]–certified specialists without subspecialty training); and 4) expert (ABOG-certified obstetrician–gynecologists who had completed a 2-year fellowship in minimally invasive gynecologic surgery). Qualified participants were oriented to both systems, followed by testing with five laparoscopic exercises (L-1, sleeve-peg transfer; L-2, pattern cut; L-3, extracorporeal tie; L-4, intracorporeal tie; L-5, running suture) and two hysteroscopic exercises (H-1, targeting; H-2, polyp removal). Measured outcomes included accuracy and exercise times, including incompletion rates. RESULTS: Of 227 participants, 77 were novice, 70 were mid-level, 33 were proficient, and 47 were experts. Exercise times, in seconds (±SD), for novice compared with mid-level participants for the seven exercises were as follows, and all were significant (P

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Endometrial ablation (EA) includes a spectrum of procedures performed with or without hysteroscopic direction, designed to destroy the endometrium for the treatment of the symptom of heavy menstrual bleeding (HMB) secondary to a spectrum of causes, but most commonly those that are endometrial in origin (AUB-E) or ovulatory disorders (AUB-O). Resectoscopic endometrial ablation (REA) is often mistakenly referred to as the "first generation" technique, while proprietary devices that do not use the resectoscope (nonresectoscopic EA or NREA) are often misperceived as "second generation" devices. Indeed, the origins of NREA date back to the late 19th century with the use of steam, and the early and mid 20th century, when radiofrequency and cryotherapy based NREA techniques were published - long before the resectoscope was used and reported. The NREA devices have also been mislabeled as "global", a misleading term borrowed from the marketing departments of device manufacturers - there is no device that predictably treats the entire endometrium. Consequently, none can be construed as being "global". Instead, EA is a procedure designed for women as an alternative to hysterectomy, or, perhaps, medical therapy, when future fertility is no longer desired. Women who select EA should anticipate a relatively low risk procedure that will likely reduce their HMB to normal levels or less. This paper will review the spectrum of EA techniques and devices, their clinical outcomes and adverse events, and explore their value compared to hysterectomy and selected medical therapies.

Objective To conduct a review of the available histologic and image-based classification systems to determine which of these systems, if any, provide clinical utility for prognosis or the selection of appropriate therapeutic interventions. Data Sources PubMed in addition to the bibliographies of identified publications. Methods of Study Selection One investigator searched PubMed using Medical Subject Headings terms that included “Adenomyosis,” “Classification,” “Ultrasound Classification,” “MRI Classification,” and “Diagnosis,” Tabulation, Integration and Results Search results were tabulated in a Microsoft Excel workbook that facilitated the identification of duplicate entries. Publications were allocated into separate categories that included histopathologic, ultrasound, and MRI classifications. Identified systems associated with clinical outcomes were separately tabulated. Abstracts of 1669 articles were reviewed and 278 were identified for review of full text. Twenty-five were considered potentially relevant from the PubMed review and an additional 17 were found in bibliographies. In the 42 full-text articles that were reviewed in detail, 9 histologic classifications were identified, 4 of which were accompanied by an attempt at clinical correlation, 1 of which described a correlation with the outcome of medical, procedural, or surgical intervention. There were 9 image-based reporting or classification systems, 2 using transvaginal ultrasound and 7 using MRI, 3 of which included correlations with intervention outcomes, although these were surrogate (imaging) and not clinical outcomes. Conclusion There is inconsistency in histopathologic definitions, and there is no uniformly accepted or validated system of image-based reporting or classification that can inform clinical decision making. There exists a need for harmonized classification systems for both ultrasound and MRI that agree with the histopathologic features of the disorder.

Study Objective To evaluate the Essentials in Minimally Invasive Gynecology (EMIG)- Fundamentals of Laparoscopic Surgery Laparoscopic Simulation System and the EMIG Hysteroscopy Simulation System for face validity and functionality in a pilot testing environment. Design A prospective controlled pilot study. Setting Three teaching institutions in the US Southwest. Subjects Twenty-seven residents and gynecologists, with 22 fitting who fit 1 of 4 categories of exposure to hysteroscopic and laparoscopic surgery and surgical simulation. Eleven were postgraduate year 1 and 5 postgraduate year 3, 1 was American Board of Obstetrics & Gynecology certified, and 5 were either fellows in-training or had completed a fellowship in minimally invasive gynecologic surgery. Interventions After completing a screening survey, each subject was exposed to a structured orientation to the 2 simulation systems and then tested with proctor supervision on the 5 laparoscopic and 2 hysteroscopic exercises. A short 5-point Likert questionnaire designed to determine face validation and question clarity was administered to each subject at sites 2 and 3. Measurements and Main Results Face validity was high for each of the 7 exercises (means ranged from 4.8 to 4.9 of 5), and subjects considered instructions to be clear (means from 4.7 to 4.9). The recorded exercise times generally reduced with increasing levels of training, although the sample sizes were not designed to determine significance given the pilot design. Similarly, exercise errors were generally less frequent with increasing experience. The systems, including the devices and recording mechanisms, performed well, and proctor evaluation and training were satisfactory. Conclusion The EMIG laparoscopic and hysteroscopic simulations systems were considered to have good face validity and appear to be suitable for a construct validation trial to confirm their utility in distinguishing among trainees and practitioners with a wide spectrum of endoscopic surgical experience. The recording and specimen storage mechanisms will allow for multiple proctors to rate a candidate's performance, thereby enhancing evaluation consistency and quality.

We conducted a systematic review and meta-analysis to assess the safety and effectiveness of robotic versus laparoscopic hysterectomy in women with benign uterine disease, as determined by randomized studies. We searched MEDLINE, EMBASE, the Cochrane Library, ClinicalTrials.gov, and Controlled-Trials.com from inception to October 9th, 2014, using the intersection of the themes “robotic” and “hysterectomy.” We included only randomized and quasi-randomized controlled trials of robotic versus laparoscopic hysterectomy in women for benign disease. Four trials met inclusion criteria and were included in the analyses. Data was extracted and studies were assessed for methodological quality in duplicate. For meta-analysis, we used random effects to calculate pooled risk ratios (RR) and weighted mean differences. For our primary outcome, we used a modified version of the Expanded Accordion Severity Grading System to classify perioperative complications. We identified 41 total complications among 326 patients. When comparing robotic to laparoscopic hysterectomy, we found no statistically significant differences in the rate of class 1 and 2 complications (RR=0.66, 95% Confidence Interval (CI) 0.23–1.89) or in the rate of class 3 and 4 complications (RR=0.99, 95%CI 0.22–4.40). Analyses of secondary outcomes were limited due to heterogeneity, but showed no significant benefit of robotic compared to laparoscopic technique in terms of length of hospital stay (weighted mean difference= −0.39 days, 95%CI −0.92–0.14), total operating time (weighted mean difference=9.0 minutes, 95%CI −31.27–47.26), conversions to laparotomy, or blood loss. Outcomes of cost, pain, and quality of life were inconsistently reported and not amenable to pooling. Current evidence demonstrates neither statistically significant, nor clinically meaningful differences in surgical outcomes between robotic and laparoscopic hysterectomy for benign disease. The role of robotic surgery in benign gynecology remains unclear.

Adverse events associated with hysteroscopic procedures are generally rare, but, with increasing operative complexity, it is now apparent that they are experienced more often. There exists a spectrum of complications that relate to generic components of procedures, such as patient positioning, anesthesia, and analgesia, to a number that are specific to intraluminal endoscopic surgery that largely comprise perforation and injuries to surrounding structures and blood vessels. Whereas a number of endoscopic procedures require the use of distending media, the response of premenopausal women to excessive absorption of nonionic fluids used for hysteroscopy is somewhat unique, and deserves special attention on the part the surgeon. There is also an increasing awareness of uncommon but problematic sequelae related to the use of monopolar radiofrequency uterine resectoscopes that involve thermal injury to the vulva and vagina. Furthermore, the uterus that has previously undergone hysteroscopic surgery may behave in unusual ways, at least in premenopausal women who experience menstruation or who become pregnant. Fortunately, better understanding of the mechanisms involved in these adverse events, as well as the use or development of a number of innovative devices, have collectively provided the opportunity to perform hysteroscopic and resectoscopic surgery in a manner that minimizes risk to the patient.

To evaluate the accuracy of traditional blind uterine sounding in measuring uterine cavity length (UCL), compared with measurement by hysteroscopic guidance.A cross-sectional descriptive study (Canadian Task Force classification III).Academic multispecialty medical center.Fifty-eight women undergoing elective hysteroscopic procedures.UCL measurement.UCL measurements were obtained by the traditional blind sounding technique and by hysteroscopically directed measurement. Hysteroscopic measurements were assumed to represent true uterine cavity length. Differences between the 2 measurements were calculated to analyze error and bias.Mean UCL for blind sounding and hysteroscopically directed measurements were 80.81 mm and 86.55 mm, respectively. The magnitude of error between measurements was10 mm in 36.2% of cases, with underestimation of true UCL in 55.17% of cases.True UCL is underestimated by blind sounding, and the frequency, magnitude, and direction of error may be greater than are clinically acceptable.

Adverse events due to energy device use in surgical operating rooms are a daily occurrence. These occur at a rate of approximately 1–2 per 1000 operations. Hundreds of operating room fires occur each year in the United States, some causing severe injury and even mortality. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) therefore created the first comprehensive educational curriculum on the safe use of surgical energy devices, called Fundamental Use of Surgical Energy (FUSE). This paper describes the history, development, and purpose of this important training program for all members of the operating room team. The databases of SAGES and the FUSE committee as well as personal photographs and documents of members of the FUSE task force were used to establish a brief history of the FUSE program from its inception to its current status. The authors were able to detail all aspects of the history, development, and national as well as global implementation of the third SAGES Fundamentals Program FUSE. The written documentation of the making of FUSE is an important contribution to the history and mission of SAGES and allows the reader to understand the idea, concept, realization, and implementation of the only free online educational tool for physicians on energy devices available today. FUSE is the culmination of the SAGES efforts to recognize gaps in patient safety and develop state-of-the-art educational programs to address those gaps. It is the goal of the FUSE task force to ensure that general FUSE implementation becomes multinational, involving as many countries as possible.

Operating room (OR) safety has become a major concern in patient safety since the 1990s. Improvement of team communication and behavior is a popular target for safety programming at the institutional level. Despite these efforts, essential safety gaps remain in the OR and procedure rooms. A prime example is the use of energy-based devices in ORs and procedural areas. The lack of fundamental understanding of energy device function, design, and application contributes to avoidable injury and harm at a rate of approximately 1 to 2 per 1000 patients in the US. Hundreds of OR fires occur each year in the US, some causing severe injury and even death. Most of these fires are associated with the use of energy-based surgical devices.In response to this safety issue, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) developed the Fundamental Use of Surgical Energy (FUSE) program. This program includes a standardized curriculum targeted to surgeons, other physicians, and allied health care professionals and a psychometrically designed and validated certification test. A successful FUSE certification documents acquisition of the basic knowledge needed to safely use energy-based devices in the OR. By design FUSE fills a void in the curriculum and competency assessment for surgeons and other procedural specialists in the use of energy-based devices in patients.

Hysterectomy remains one the most common procedures performed in North America. Because of a better understanding of a wide array of disease states and with emerging, more focused minimally invasive treatment options, a relative decline has been documented in the last several years. Although hysterectomy will ultimately eliminate all potential sources of abnormal uterine bleeding, various pharmacologic and surgical alternatives exist that may provide comparable benefit to the majority of women, especially if older than 40 years. Women experiencing chronic pelvic pain; however, should be counseled against hysterectomy until a more clear etiology has been identified.

Acute uterine bleeding unrelated to pregnancy has been defined as bleeding “sufficient in volume as to, in the opinion of the treating clinician, require urgent or emergent intervention.” The Southern California Permanente Medical Group updated its guidelines for the management of this condition on the basis of the best available evidence, as identified in a systematic review of the available literature. Given the paucity of studies evaluating this condition, the guidelines, by necessity, include recommendations largely based on opinion or other sources such as case series that are, in general, categorized as low-quality evidence. Medical interventions with single or combined gonadal steroidal agents administered parenterally or orally show promise, but more high-quality studies are needed to better define the appropriate drugs, dose, and administrative scheduling. There is also some evidence that intrauterine tamponade may be useful in at least selected cases. Special attention must be paid to both diagnosing and treating inherited disorders of hemostasis, such as von Willebrand disease, that may otherwise be underdiagnosed in both adolescent and adult women.

Almost all surgical procedures involve the use of devices that apply energy to tissue. Adverse events can occur if the devices are not used appropriately. The SAGES’ Fundamental Use of Surgical Energy™ (FUSE) program will include a curriculum and certification examination to address this safety issue. The aim of this study was to determine the self-perceived knowledge of practicing surgeons related to energy-based devices and identify areas to emphasize in the assessment component of FUSE. Psychometric experts led the test development process. During a 2-day retreat, a multidisciplinary group defined 63 test objectives assessing the knowledge and skills required to use energy-based surgical instruments safely (job task analysis). A survey was sent to a sample of 103 SAGES leaders and others in the test target audience to determine the number of items to use for the certification examination. Participants rated each objective for frequency, relevance, and importance on a 1–7 scale with the means used to create a weighted scale. The survey also included five self-assessment questions. Fifty surveys were completed; only 28 % of respondents considered themselves “experts.” The most common source of knowledge was “industry sales representative or course” (42 %). The highest weighted topic was “Prevention of Adverse Events with Electrosurgery.” The highest-rated objectives (>6 out of 7) were “Identify various mechanisms whereby electrosurgical injuries may occur,” “Identify patient protection measures for setup and settings for the electrosurgical unit,” and “Identify circumstances, mechanisms, and prevention of dispersive electrodes-related injury.” Although basic and advanced energy-based devices are commonly used, training has been largely dependent upon industry representatives or industry-sponsored courses. Few surgeons consider themselves experts in the mechanisms of action and the appropriate and safe use of energy-based surgical devices. Competencies that emphasize electrosurgical safety were viewed as most important for the FUSE certification examination.

Energy-based instrumentation has not only facilitated the rapid adoption of laparoscopic surgery, but could be considered essential for the completion of abdominal and pelvic procedures under endoscopic guidance. For decades, relatively simple and generic reusable monopolar and bipolar systems were the only options available. More recently, the available options for energy-based surgical instrumentation have become more crowded with the introduction of ultrasound-based cutting and sealing instruments and proprietary, impedance monitoring radiofrequency coagulation devices. Such instrumentation is presented as being easier to use as well as providing greater safety and efficacy. However, these new instruments typically require the expenditure of capital for proprietary energy generators and are usually designed to be for single use, a circumstance that increases per case costs, a circumstance that begs the question of value. Do the additional costs expended for the more expensive devices translate into reduced complications, faster operating time, or even wider access to minimally invasive procedures because they enable more surgeons to offer the service? Herein is explored the complex economic issues associated with the use of energy-based surgical devices as they apply to minimal access surgery in general and to laparoscopic procedures specifically.

The FIGO systems defining the nomenclature and symptoms of abnormal uterine bleeding (AUB) in the reproductive years (System 1) and the PALM-COEIN classification of causes of AUB (System 2) are designed to facilitate research, education, and the provision of optimum clinical care for affected women. Development of these systems has been the result of a collaborative effort of experts in bench and translational and clinical research from six continents aided by a spectrum of representatives from relevant medical societies, journals, and regulatory bodies. Integral to this development has been a decision to cease the use of poorly defined and inconsistently used terms such as menorrhagia, metrorrhagia, and dysfunctional uterine bleeding, to name a few, and replace them with a set of terms and definitions that are relatively easily understood and translated into the spectrum of languages used by medical providers and patients globally. The utilization of these systems requires a disciplined approach to obtaining a menstrual history, relatively simple laboratory investigations, and the appropriate use of imaging techniques accessible to most clinicians worldwide. This section describes the two systems, their crucial role in guiding investigation, and an approach to implementation, all designed to facilitate the creation of a menu of therapeutic options, considering the identified factors contributing to the problem of nongestational AUB.

There exists a spectrum of potential causes of abnormal uterine bleeding (AUB) in nonpregnant reproductive-aged women. In some instances the abnormal bleeding may emanate from definable pathologic entities in the endometrial cavity such as polyps or submucous leiomyomas (fibroids), while in others, it may occur secondary to coagulopathies or disorders of local or systemic hemostasis. If the patient is subjected to a rigorous evaluation more than one potential contributor may be identified, a circumstance that challenges the clinician since entities such as polyps, leiomyomas, and adenomyosis may frequently be asymptomatic, even in women with AUB. The bench or clinical investigator may also be influenced by the existence of the multiplicity of potential causes that could confound the results of research. This paper describes FIGO's (Fédération Internationale de Gynécologie et d'Obstétrique) new PALM-COEIN classification of causes of AUB in the reproductive years (Polyp, Adenomyosis, Leiomyoma, Malignancy and hyperplasia-Coagulopathy, Ovulatory disorder, Endometrial, Iatrogenic, Not yet classified). This system is designed to assist clinicians in the evaluation of patients, investigators in the design and interpretation of research and faculty in the education of medical students and residents/trainees. Additionally, given the longstanding existence of a confusing array of conflicting definitions, the manuscript describes the FIGO standardized terminology for both normal menstruation and AUB symptoms.

It is now clear to most stakeholders that acquisition of surgical psychomotor skills is best achieved outside of the clinical operating room, in the context of a simulated environment. Endoscopic simulation can be accomplished using simple "box" simulators or video trainers, and virtual reality simulation is now possible using microprocessor-controlled systems. Structured surgical training performed outside of the operating room environment is relatively new to health care, a circumstance different from the process of pilot training, in which simulation has been a mainstay for more than 75 years and in which virtual reality simulation is now the norm. Those charged with surgical education are faced with a dilemma as, while attempting to understand the basic goals of simulation, they are simultaneously faced with choice between relatively inexpensive video trainers and the often prohibitively expensive virtual reality systems. This article explores the history of simulation, reports the results of a modified systematic review of currently available systems and performance, and identifies the gaps in current research and development. It is apparent that available video trainers provide the opportunity for skill development that at present is not surpassed by virtual reality systems. In the future, there will likely be an increasing role for virtual reality; however, challenges remain that include determination of the appropriate metrics and system design, and the fiscal resources necessary for the required hardware and related software development.

This article describes a modern perspective on the basic investigations for abnormal uterine bleeding (AUB) in low-resource settings compared with a much more detailed approach for high-resource settings, bearing in mind issues of effectiveness and cost effectiveness. AUB includes any one or more of several symptoms, and it should be evaluated for the characteristics of the woman's specific bleeding pattern, her "complaint" and the presence of other symptoms (especially pain), the impact on several aspects of body functioning and lifestyle, and the underlying cause(s), especially cancer. Ideally, the evaluation is comprehensive, considering each of the potential etiological domains defined by the International Federation of Gynecology and Obstetrics PALM-COEIN system for the classification of causes. However, the detail of the questions and the extent of investigations will be significantly influenced by the technologies available and the time allotted for a consultation. In general, investigations should be performed only if they will make a material difference to the management approaches that can be offered. This should be an important consideration when a range of costly high-technology tests is accessible or when certain tests only have limited availability.

Abnormal uterine bleeding (AUB) is a prevalent symptom that encompasses abnormalities in menstrual regularity, duration, frequency and/or volume, and it is encountered frequently by both primary care physicians and obstetrician-gynecologists. Research on AUB has used numerous methods to measure bleeding and assess symptoms, but the lack of universally accepted outcome measures hinder the quality of research and the ability of clinical investigators to collaborate in multicenter trials. Similarly, clinical care for women reporting heavy, prolonged, or irregular menstrual bleeding is not optimized because standard ways of evaluating symptoms and change in symptoms over time do not exist. This article describes (1) the current methods of evaluating women with AUB, both in research and clinical care; and (2) offers suggestions for the development of a standardized structured menstrual history for use in both research and clinical care.

This pilot study suggests that virtual reality resectoscopic systems have the potential to measure and improve the technical skills of novices before they operate on human patients., Background and Objectives: Recognizing that resectoscopic simulation may have an educational role, this pilot study was designed to evaluate the face validity and educational utility of a virtual reality uterine resectoscope training system. Methods: A pilot prospective comparative study of novice and expert hysteroscopists' performance on a targeting exercise and myomectomy with the virtual loop electrode. At baseline, expert and novice resectoscopists each performed both exercises. Following instruction, novices practiced each exercise a total of 9 times with the 10th recorded as the training outcome. Results were compared both to baseline and to those of the experts. Data were analyzed with the paired t and Wilcoxon rank sum tests as appropriate. Results: At baseline, all experts touched 4 targets in a mean of 33 seconds with no perforations, compared to a mean of 2 for the 11 novices in a mean of 57 seconds (P=0.0034) with one perforation. In 3 minutes, the experts removed a mean of 97.3% of the virtual myoma, compared to 66.1% for the novices (P=0.0153). On the 10th “run,” novices touched a mean of 4 targets in a mean of 23 seconds, an improvement from baseline (P=0.0004) and improved to 89% on the myoma resection exercise (P=0.0515) 36.3% over baseline. Conclusion: Although this pilot study has a relatively small sample size and represents the results at one institution, it demonstrates that virtual reality resectoscopic systems have the potential to measure and improve the technical skills of novices before they operate on human patients.

Background There is a variety of potential advantages to performing hysteroscopically-directed procedures on an awake patient in an office procedure room setting that include increased safety, reduced utilization of resources, and improved patient satisfaction. However, the ideal approach to local uterine anesthesia has/have yet to be determined. Objective Identification, categorization, and evaluation of published randomized clinical trials (RCTs) comparing local anesthesia to placebo or no treatment for the performance of hysteroscopy. Methods The Cochrane database of systematic reviews, MEDLINE, and ACP Journal Club were queried for related RCTs. In addition, we located a number of additional studies by identifying and reviewing references in selected papers. These were then reviewed for appropriateness and categorized by allocating them to one of the following types of local anesthesia: Intracervical, paracervical, topical intracavitary, topical cervical, and combined approaches. Each were evaluated for patient factors as well as anesthetic location, anesthetic agent, time from application to procedure, instrument features, and the procedures performed. Results A total of 36 studies were identified of which 19 met the criteria for our review; 6 paracervical, 4 intracervical, 7 topical intracavitary, 2 topical cervical; there was also one systematic review of RCTs. Overall, there was substantial heterogeneity in technique in all groups and only with paracervical anesthesia was there a consistent anesthetic effect demonstrated. Many studies were performed with application to procedure times that were less than the time required for maximal anesthetic effect. There were no studies identified where more than one technique was used. Conclusions It appears that paracervical anesthesia is useful but the value of other techniques is difficult to evaluate because of limitations of technique and research design. Future investigation should be designed to evaluate longer application to procedure times, a variety of anesthetic agents, concentrations and volumes, and, given the complex innervation of the uterus, strategies that target more than one site. Pain outcomes should be stratified to identify the impact on various components of the procedure. Published studies have largely been limited to diagnostic hysteroscopy so there is also a need to evaluate a greater variety of hysteroscopic procedures.

Adverse events associated with hysteroscopic procedures are in general rare, but, with increasing operative complexity, it is now apparent that they are experienced more often. A spectrum of complications exist ranging from those that relate to generic components of procedures such as patient positioning and anesthesia and analgesia, to a number that are specific to intraluminal endoscopic surgery (perforation and injuries to surrounding structures and blood vessels). The response of premenopausal women to excessive absorption of nonionic fluids deserves special attention. There is also an increasing awareness of uncommon but problematic sequelae related to the use of monopolar uterine resectoscopes that involve thermal injury to the vulva and vagina. The uterus that has previously undergone hysteroscopic surgery can behave in unusual ways, at least in premenopausal women who experience menstruation or who become pregnant. Better understanding of the mechanisms involved in these adverse events, as well as the use or development of several devices, have collectively provided the opportunity to perform hysteroscopic and resectoscopic surgery in a manner that minimizes risk to the patient.

Objective To summarize and evaluate the patient-based outcome measures (PBOMs) that have been used to study women with abnormal uterine bleeding (AUB). Design Systematic review. Setting Original articles that used at least one PBOM and were conducted within a population of women with AUB. Patient(s) Women with AUB. Intervention(s) The titles, abstracts, and studies were systematically reviewed for eligibility. The PBOMs used in eligible studies were summarized. Essential psychometric properties were identified, and a list of criteria for each property was generated. Main Outcome Measure(s) "Quality" of individual PBOMs as determined using the listed criteria for psychometric properties. Result(s) Nine hundred eighty-three studies referenced AUB and patient-reported outcomes. Of these, 80 studies met the eligibility criteria. Fifty different instruments were used to evaluate amount of bleeding, bleeding-related symptoms, or menstrual bleeding–specific quality of life. The quality of each of these instruments was evaluated on eight psychometric properties. The majority of instruments had no documentation of reliability, precision, or feasibility. There was no satisfactory evidence that any one instrument completely addressed all eight psychometric properties. Conclusion(s) Studies of women with AUB are increasingly using PBOMs. Many different PBOMs were used; however, no single instrument completely addressed eight important measurement properties.

Purpose In this study, we sought to 1) describe elements of the financial and quality-of-life burden of dysfunctional uterine bleeding (DUB) from the perspective of women who agreed to obtain surgical treatment; 2) explore associations between DUB symptom characteristics and the financial and quality-of-life burden; 3) estimate the annual dollar value of the financial burden; and 4) estimate the most that could be spent on surgery to eliminate DUB symptoms for which medical treatment has been unsuccessful that would result in a $50,000/quality-adjusted life-year incremental cost-effectiveness ratio. Methods We collected baseline data on DUB symptoms and aspects of the financial and quality-of-life burden for 237 women agreeing to surgery for DUB in a randomized trial comparing hysterectomy with endometrial ablation. Measures included out-of-pocket pharmaceutical expenditures, excess expenditures on pads or tampons, the value of time missed from paid work and home management activities, and health utility. We used χ 2 and t tests to assess the statistical significance of associations between DUB characteristics and the financial and quality-of-life burden. The annual financial burden was estimated. Results Pelvic pain and cramps were associated with activity limitations and tiredness was associated with a lower health utility. Excess pharmaceutical and pad and tampon costs were $333 per patient per year (95% confidence interval [CI], $263–$403). Excess paid work and home management loss costs were $2,291 per patient per year (95% CI, $1847–$2752). Effective surgical treatment costing $40,000 would be cost-effective compared with unsuccessful medical treatment. Conclusion The financial and quality-of-life effects of DUB represent a substantial burden.

BACKGROUND: A subgroup of women with Asherman’s syndrome has adhesions of limited extent completely blocking the lower uterine cavity or upper cervix, whereas the upper endometrium remains normal. Haematometra are rarely found in these women. We tested the hypothesis that women with localized adhesions occluding the uterine outlet (but not affecting the upper uterine cavity) will have much thinner endometrium than controls. METHODS: Twenty-six women with Asherman’s syndrome (16 with limited outlet adhesions only) and 50 with normal menstrual cycles underwent transvaginal ultrasound scan where endometrial double thickness was measured precisely and the cycle phase assessed. The presence of any fluid in the uterine cavity was noted. RESULTS: The endometrium in women with Asherman’s syndrome, in whom uterine outlet blockage was the sole abnormality (subgroup 3), was substantially thinner (mean+ SEM: 3.9+ + 0.4 mm) than controls (8.5+ 0.05; P< 0.001), and haematometra were very uncommon (1 of 16). Endometrial thickness at all stages of the ovarian/menstrual cycle in all three subgroups of Asherman’s syndrome was significantly less than in normal menstruating controls. CONCLUSIONS: Non-invasive ultrasound measurements have demonstrated very thin endometrium and absence of haematometra in most women with uterine outlet occlusion by adhesions. This unusual phenomenon of failure of cyclical endometrial growth and breakdown in the sole presence of cervical occlusion by adhesions merits further study.

To compare the effectiveness of hysterectomy and endometrial ablation in women with dysfunctional uterine bleeding.The Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding was a multicenter, randomized controlled trial. Eligible women were premenopausal with dysfunctional uterine bleeding and aged 18 years or older. Primary outcomes were problems that led the woman to seek care solved, bleeding, pain, and fatigue at 12 months. Additional outcomes included quality of life, adverse events, reoperation, and others at 24 months and up to 5 years.We randomly assigned 237 women between January 1998 and June 2001. Follow-up ended in June 2003. We completed 24 months of follow-up on 114 of 123 women assigned to endometrial ablation and 111 of 114 assigned to hysterectomy. Approximately 85% of women were aged younger than 45 years; 76.4% classified themselves as white, 18.6% as African American, less than 1% as Asian, 4.6% as American Indian, and 8.4% as Hispanic (classification within more than one category possible). Both endometrial ablation and hysterectomy were effective at 24 months in solving the problem that led women to seek care (84.9% compared with 94.4%), and in relieving bleeding, pain, fatigue, and other symptoms, although hysterectomy was more effective for bleeding. By 48 months, 32 of the 110 women initially receiving endometrial ablation required reoperation. Adverse events were more frequent with hysterectomy.Both endometrial ablation and hysterectomy are effective treatments in women with dysfunctional uterine bleeding. Hysterectomy (as the index surgery) was associated with more adverse events and a substantial number of patients receiving endometrial ablation had reoperation.ClinicalTrials.gov, www.clinicaltrials.gov, NCT00114088I.

Both hysterectomy for heavy menstrual bleeding and radical mastectomy for breast cancer are steeped in the history of surgery and have recently been challenged as being too radical for the disorder at hand. Radical mastectomy has largely been replaced with local removal of the tumor with subsequent radiation and/or chemotherapy. Alternatives to hysterectomy include a number of medical interventions, most notably intrauterine progestin-releasing systems, and endometrial ablation, a procedure that has a relatively high success rate and one that is now feasible for many women in an office or procedure room setting. However, although radical mastectomy rates have dropped precipitously, hysterectomy rates, at least in the United States remain relatively stable. Determining the proportion of hysterectomies that are done for heavy menstrual bleeding is difficult, largely because of coding issues, so it is difficult to measure the impact of new medical and minimally invasive surgical procedures. Nevertheless, it seems clear that many women are not exposed to the plethora of options to hysterectomy, a fact that may reflect a number of issues that may include training, skill, and financial incentives or disincentives. Clearly, options to hysterectomy are not a panacea, but if women are empowered to select from all of the options available, the rate of hysterectomy for bleeding should decrease while maintaining, or even enhancing the patient's satisfaction with care.

Background There is considerable worldwide confusion in the use of terminologies and definitions around the symptom of abnormal uterine bleeding, and these are leading increasingly to difficulties in setting up multinational clinical trials and in interpreting the results of studies undertaken in single centers. Objective To develop an agreement process through an international initiative to recommend clear, simple terminologies and definitions that have the potential for wide acceptance. Design After widespread consultation with relevant international and national organizations, journal editors, and individuals, a modified Delphi process was developed to assess current use of terminologies, followed by a structured face-to-face meeting of 35 clinicians (mostly gynecologists) and scientists in Washington, DC. Focused small-group discussions led to plenary assessment of concepts and recommendations by using an electronic keypad voting system. Setting An international group of experts on disorders of menstruation. Patient(s) Women with complaint of menstrual symptoms. Intervention(s) An international debate and consultation process. Main Outcome Measure(s) Expert debate and anonymous voting on agreement through use of electronic keypads. Result(s) There was almost-universal agreement that poorly defined terms of classical origin that are used in differing ways in the English medical language should be discarded and that these should be replaced by simple, descriptive terms with clear definitions that have the potential to be understood by health professionals and patients alike and that can be translated into most languages. The major recommendations were to replace terms such as menorrhagia, metrorrhagia, hypermenorrhea, and dysfunctional uterine bleeding. Suggestions for potentially suitable replacement terms and definitions are made. Conclusion(s) A simple terminology has been recommended for the description and definition of symptoms and signs of abnormal uterine bleeding. This article should be a living document and should be part of an ongoing process with international medical and community debate. Classification of causes, investigations, and cultural and quality-of-life issues should be part of the ongoing process.

Traditional medical education curricula for students, residents and trainees do not address the rapidly growing number of technological devices that are fundamentally changing health care delivery today. This is most relevant in those medical specialties that rely heavily on the use of advanced technologies and devices, for example minimally invasive surgery, interventional radiology, gastroenterology, cardiology and anesthesia. Health care professionals in these domains are increasingly sharing procedures that use energy devices of many different designs and functionality without training in their fundamental use and safety. This exposes both operators and patients to increasing risk for injury. The definitive gap in adequate education and training in new technologies prompted the development of The Fundamental Use of Surgical Energy (FUSE) program by a multidisciplinary team of clinicians, nurses, educators and engineers under the leadership of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). The sweeping changes in the surgical and interventional professions due to technological innovation call for the development of additional curricula to close the educational gap on other medically important technologies. The FUSE program and future educational curricula on medical technologies are fundamental to patient care and represent a necessary paradigm shift in traditional medical education.

Purpose of review This review evaluates the currently available evidence regarding resectoscopic endometrial ablation (REA) and the various nonresectoscopic endometrial ablation (NREA) techniques used for heavy meastrual bleeding. Recent findings Laser endometrial ablation is now used infrequently, largely because of procedure time, but also because of the cost and training associated with the technique. REA can be performed in a wider spectrum of endometrial cavity configurations than NREA and, at least in expert hands remains the gold standatrd. Each of the five available types of NREA device possesses advantages and disadvantages over the others with respect to variables such as treatment time, required cervical dilation, and size and configuration of the endometrial cavity. All provide acceptable results that are comparable to that of REA in expert hands. Serious complications seem to be less common with NREA, but uterine perforation and bowel or other visceral injury can still uterine perforation and bowel or other visceral injury can still occur. When endometrial-ablation patients were followed for up to 5 years, repeat surgery rates ranged from 20 to 40%, thereby aroding both the direct and indirect tratment-related resource utilization. Levonorgestrel-releasing intrauterine devices demonstrate similar clinical and patient-satisfaction outcomes to endometrial ablation but can be inserted in the office and allow maintenance of fertility. Both REA and NREA provde at least short- to intermediate-term options to hysterectomy for patients with heavy menstrual bbleeding and normal or near-normal endometrial cavities. Consequently, the ideal candidates are likely those who are within 5 years of menopause.

Study objective To evaluate preprocedure and postprocedure health related quality of life scores and patient satisfaction of women treated with hydrothermablation for abnormal uterine bleeding (AUB) with and without endometrial intracavitary pathology. Design Cohort study (Canadian Task Force classification II-2). Setting Two institutions from a large managed care organization. Patients Forty-seven English-speaking premenopausal women with AUB, both with and without leiomyomas or polyps in the endometrial cavity treated from January 2001 through March 2003. Intervention Patients had been treated with endometrial hydrothermablation. Measurements and main results A standardized system, validated in English (the Ruta score), was used for evaluating health-related quality-of-life impact of uterine bleeding. Following the index procedure, patients were asked to assess both baseline and current status. A simple five-point satisfaction scale also was administered. Outcomes from subjects with and without documented endometrial structural pathology were compared. Follow-up ranged from 5 to 25 months with a mean of 12.7 (SD 5.2). Twenty women in the cohort had normal endometrial cavities, and 27 demonstrated intracavitary pathology, most often leiomyomas. For both groups, baseline and follow-up scores were similar. Satisfaction scores also were similar with 80.0% of the subjects with normal endometrial cavities and 72.7% of those with abnormal cavities satisfied or highly satisfied with the outcome. Conclusion Endometrial hydrothermablation seemed to be effective for AUB-affected women, both with and without pathologic lesions in the endometrial cavity.

Study Objective To evaluate electrosurgical waveform, generator type, and electrode integrity as variables in capacitive induction of current on the external sheath of a resectoscope in open-circuit conditions. Design In vitro, laboratory, comparative study (Canadian Task Force classification CII-1). Setting Surgical laboratory Instrumentation Three ValleyLab radiofrequency (RF) electrosurgical generators (ESU), Force-2, Force-4, and Force-F/X; a resectoscope (Storz 50 series); and rollerball electrodes, both intact and with two types of standard insulation defects (lateral and circumferential) placed in two locations: distally, beyond the end of the telescope, and proximally, beside the distal aspect of the telescope. A Dynatek ESU analyzer was used to record current and wattage on electrodes and the external sheath. Measurements and Main Results With intact insulation, current was not disproportionately induced on the external sheath of the resectoscope regardless of ESU, power, or waveform. Proximally located electrode insulation defects allowed induction of most of the generator's output to the external sheath when high-voltage modulated outputs were used, and the risk varied somewhat with the ESU. There was no such induction at any power setting or with any insulation defect when low-voltage (cutting) outputs were tested. Conclusion In the presence of proximal electrode defects, high-voltage currents may contribute to thermal injury to the lower genital tract during RF resectoscopic surgery.

The Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) was a multicenter, randomized clinical trial that assessed the efficacy and effectiveness of hysterectomy versus endometrial ablation (EA) for dysfunctional uterine bleeding (DUB) in women for whom medical management has not provided relief. Resource centers included a coordinating center, a chair's office, the American College of Obstetricians and Gynecologists, the Agency for Healthcare Research and Quality Project Office and 33 clinical centers in the United States and Canada. STOP-DUB enrolled: (1) eligible patients for whom medical treatment had not been successful and who were randomized to either hysterectomy or EA and (2) an observational cohort of patients who were "provisionally ineligible" or who were eligible but did not wish to be randomized. Enrollment began in October 1997 and ended in June 2001. The primary outcome addressed by the randomized trial was the impact of surgery on bleeding, pain, fatigue, and the major problem (symptom) that led the woman to seek treatment for her condition, measured 1 year following surgery. Additional outcomes included the impact of surgery at time points after 1 year; changes in quality of life, activity limitation, sexual functioning, and urinary incontinence; surgical complications; additional surgery; and resource utilization. The costs and the relative cost-effectiveness of the two surgeries were calculated. The main scientific objective for the observational study was to examine changes over time in terms of treatment selected, DUB-related symptoms, and quality of life.

To review laparoscopic access systems, insertion techniques, and the risks of complications associated with their use.Access devices usually comprised an external cannula and a removable sharp pyramidal trocar for penetration of the abdominal wall, and were nearly universally positioned following establishment of a pneumoperitoneum. However, it is apparent that such devices and techniques contribute to patient morbidity through visceral and vascular injury, as well as incision-related complications such as dehiscence and hernia. There exist alternative approaches to positioning insufflation needles and the initial cannula, which may reduce the incidence of vascular and visceral injury particularly in the face of previous abdominal surgery. Inserting the initial cannula after minilaparotomy is associated with a reduced risk of vascular injury, but visceral complications still occur. Some new access instruments may reduce the risk of some complications associated with 'blind entry', and although not all seem to be effective in this regard, a set of blunt-tipped devices now exist, which are surprisingly easy to position and may limit the risk of injury while significantly reducing the size of the myofascial defect in the abdominal wall. Port site metastasis is a relatively newly recognized complication of oncological surgery and is a concern, but further investigation is required to determine whether such metastasis is related to a change in clinical outcome.The incidence and spectrum of access-related complications is greater than previously perceived. Newer devices and modifications in technique may reduce the incidence of such adverse events.

Objective To highlight the advantages of formal classification of causes of abnormal uterine bleeding from a clinical and scientific perspective. Design Review and recommendations for local implementation. Setting In the past, research in the field of menstrual disorders has not been funded adequately with respect to the impact of symptoms on individuals, healthcare systems and society. This was confounded by a diverse terminology, which lead to confusion between clinical and scientific groups, ultimately harming the underlying evidence base. To address this, a formal classification system (PALM-COEIN) for the causes of abnormal uterine bleeding has been published for worldwide use by FIGO (International Federation of Gynecology and Obstetrics). Population and main outcome measures This commentary explains problems created by the prior absence of such a system, the potential advantages stemming from its use, and practical suggestions for local implementation. Results and conclusions The PALM-COEIN classification is applicable globally and, as momentum gathers, will ameliorate recurrence of historic problems, and harmonise reporting of clinical and scientific research to facilitate future progress in women's health.

Postmenopausal uterine bleeding is defined as uterine bleeding after permanent cessation of menstruation resulting from loss of ovarian follicular activity. Bleeding can be spontaneous or related to ovarian hormone replacement therapy or to use of selective estrogen receptor modulators (eg, tamoxifen adjuvant therapy for breast carcinoma). Because anovulatory "cycles" with episodes of multimonth amenorrhea frequently precede menopause, no consensus exists regarding the appropriate interval of amenorrhea before an episode of bleeding that allows for the definition of postmenopausal bleeding. The clinician faces the possibility that an underlying malignancy exists, knowing that most often the bleeding comes from a benign source. Formerly, the gold-standard clinical investigation of postmenopausal uterine bleeding was institution-based dilation and curettage, but there now exist office-based methods for the evaluation of women with this complaint. Strategies designed to implement these diagnostic methods must be applied in a balanced way considering the resource utilization issues of overinvestigation and the risk of missing a malignancy with underinvestigation. Consequently, guidelines and recommendations were developed to consider these issues and the diverse spectrum of practitioners who evaluate women with postmenopausal bleeding. The guideline development group determined that, for initial management of spontaneous postmenopausal bleeding, primary assessment may be with either endometrial sampling or transvaginal ultrasonography, allowing patients with an endometrial echo complex thickness of 4 mm or less to be managed expectantly. Guidelines are also provided for patients receiving selective estrogen receptor modulators or hormone replacement therapy, and for an endometrial echo complex with findings consistent with fluid in the endometrial cavity.�

Dysfunctional uterine bleeding occurs during the reproductive years unrelated to structural uterine abnormalities. Ovulatory dysfunctional uterine bleeding occurs secondary to defects in local endometrial hemostasis; while anovulatory dysfunctional uterine bleeding is a systemic disorder, occurring secondary to endocrinologic, neurochemical, or pharmacologic mechanisms. Evaluation of patients with abnormal uterine bleeding and identifying those with dysfunctional uterine bleeding is achieved with a combination of the following: history; physical examination; and judicious use of laboratory evaluation, endometrial sampling and uterine imaging, with sonographic techniques and/or hysteroscopy. Coagulopathies should be considered as should the notion that intramural and subserosal myomas are unlikely to contribute to AUB. High-quality evidence suggests that medical therapy is frequently successful, and newer approaches, such as local delivery of progestins via intrauterine devices, appear to be particularly promising and devoid of systemic side effects. For those intolerant of medical therapy, and/or for whom fertility is no longer desired, a number of minimally invasive surgical options for hysterectomy now exist and are collectively termed endometrial ablation. Endometrial ablation may be performed with or without hysteroscopic guidance. There is an increasing body of evidence that suggests that nonhysteroscopic endometrial ablation may be at least as effective as hysteroscopic endometrial ablation, even when the hysteroscopic procedure is performed by experts.

Abnormal uterine bleeding occurs secondary to a wide variety of functional and structural abnormalities. Although there is clearly a place for surgery, medical therapy has enormous potential for most women, especially those with dysfunctional uterine bleeding. To provide women with appropriate options for therapy, the clinician must be prepared to distinguish abnormal bleeding that is associated with ovulation from that which is anovulatory and to use appropriate ancillary tests to identify structural and endocrinologic anomalies or lifestyle factors that may explain the bleeding. In undertaking such an investigation, it is important for the clinician to be able to distinguish lesions that may be asymptomatic and unrelated to the bleeding from those that truly are the source of the problem. With this information, a rationally determined set of medical and, if appropriate, surgical therapeutic options may be presented to the woman. Among these medical treatment options are a number of treatment options that have not seen widespread use in North America but are inexpensive, effective, and well tolerated. It is clear that medical therapy is not for everyone. Women deserve the opportunity to relieve their symptoms with nonsurgical options.

Objective: Laparoscopic trocar-cannula systems of different design but similar internal diameter result in incisions of varying dimensions. Such variations might affect the incidence of incisional complications, such as dehiscence and hernia. We developed a system to measure associated fascial defects and then used the techniques to compare the defects resulting from different trocar-cannula systems. Methods: This was a randomized, observer-blinded study. Six laparoscopic trocar-cannula systems of similar diameter (12 mm) were tested (two pyramidal, two blunt conical, and two cutting-dilating) using a white swine model. All systems were inserted into each of 12 subjects, with location designated by random allotment (total 72 insertions). The fascial defects were exposed and then directly measured for incisional length and area by an observer blinded to the system used. Means of each outcome variable (incisional length and area) were compared using factorial analysis of variance. Results: The values for mean incisional areas were as follows: cutting-dilating 28.73 mm2 and 31.09 mm2, pyramidal 18.25 mm2 and 26.75 mm2, and blunt conical 10.00 mm2 and 12.33 mm2. Mean maximal incisional lengths were similar among all trocar-cannula systems. Conclusion: Blunt conical trocar-cannula systems resulted in significantly smaller fascial defects compared with the widely used pyramidal and the two cutting-dilating trocar-cannula systems tested. These differences have potential clinical implications. For example, smaller fascial defects could reduce risk of incisional hernia and dehiscence.