Search

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.

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

Study Objective The aim of this study is to assess the safety and efficacy of the IUB SEAD™ (Intra Uterine Ball: Spherical Endometrial Ablation Device) introducing silver nitrate to the uterus in women suffering from abnormal uterine bleeding. We present results of 6 months follow up period post treatment. Design Open-label multicenter study to assess the safety and efficacy of the IUB SEAD™ device in premenopausal women with predictable menstrual cycles, who suffer from AUB. Women with HMB were enrolled who had an average pictorial blood loss assessment chart (PBAC) score ≥ 150 over for 3 months. Setting The study was performed in the outpatient clinics of 2 Bulgarian medical centres between September 2019 and December 2020. Patients or Participants 16 women with HMB (PBAC>150) at least 3 months before inclusion were enrolled. Interventions Eligible subjects who met all the inclusion/exclusion criteria were treated during the first 7 days following the cessation of menses. The SEAD™ device was inserted into the uterine cavity via vaginal approach. The device was left in the uterus for 30 (±5) minutes and then removed. Measurements and Main Results A total of 16 participants aged 37-50 (mean = 43) were enrolled with a mean baseline PBAC score of 424; 14 of 16 completed follow up requirements and were evaluable at 6 months. All procedures were completed successfully without device/procedure-related adverse events. At 6 months post-treatment the mean PBAC score was 95 with 55% of the overall cohort ≤75 and 72% ≤ 100 and a mean percentage of 83% reduction. The mean procedure related pain score was ≤2 (mild).* Conclusion The IUB SEAD™ device is safe and effective in treating HMB in an outpatient environment. Future studies with larger number of patients are planned. *Results may vary until presentation date.

/

Background: Iron deficiency anemia (IDA) is a multifaceted condition associated with immense obstetrical morbidity and mortality, and is especially prevalent in female patients of reproductive age.Abnormal uterine bleeding (AUB), which often manifests clinically as heavy menstrual bleeding (HMB), is the leading cause of IDA among reproductive age women in the United States, with a prevalence ranging from ~30-50% in this patient population; further, HMB is estimated to account for nearly one-third of all IDA causes worldwide. For these reasons, AUB/HMB is generally accepted as the primary causal source of IDA in daily clinical practice.As frontline clinicians who routinely manage HMB, OB/GYNs are optimally positioned to subsequently recognize, diagnose, and treat the IDA precipitated by HMB. However, to ensure the provision of safe and effective care, adaptive educational initiatives with an emphasis on evolving iron supplementation strategies are needed. Methods: Creative Educational Concepts (CEC) conducted a literature review, needs assessment, and detailed gap analysis to identify prominent clinical and educational gaps that exist among OB/GYNs with regard to IDA sign and symptom recognition, epidemiology, clinical gravity and risk factors, formal diagnosis, and appropriate treatment.Consequently, our team at CEC composed a responsive, multi-pronged educational design targeted to obstetricians, gynecologists, and women's health professionals, in a tailored effort to bridge the aforementioned gaps in current practice and improve outcomes for patients.CEC consulted with top experts in obstetrics and gynecology, maternal fetal medicine, pelvic surgery, and hematology at every stage of the educational design and delivery continuum, from proposal ideation to content development to live, on-site presentation.To dynamically engage the target audience, especially at the community, grassroots level, this educational initiative was delivered at a series of five American College of Obstetricians and Gynecologists (ACOG) District Meetings across the United States; live meetings were held in Lake Geneva, WI; San Diego, CA; Kapalua, HI; Rockport, ME; and Manhattan, NY. Results: 203 total clinicians were educated across the initiative Profession MD/DO - 93%APRN/CNM - 3%RN - 2%Other - 2%Specialty General OB/GYN - 81%Maternal/fetal Medicine - 11%Reproductive endocrinology - 4%Pelvic medicine/surgery - 2%Other - 2%>5,000 IDA patients potentially impacted per month as a result of the initiativeStatistically significant advances in learning and knowledge were achieved from pre- to post-activity for all tested educational gaps: Identification of IDA risk factors (85% post vs. 46% pre; P Conclusions: Our 2019 ACOG District Meeting educational initiative precipitated substantive practice advances in knowledge, competence, and performance among OB/GYNs and women's health professionals related to IDA management.Statistically significant performance improvements in appropriate initiation of IV iron for treatment of HMB-associated IDA were achieved at follow-up assessment.Learning and knowledge endpoints for IDA risk factor recognition and AUB clinical implications were not retained with statistical significance at follow-up assessment, thereby evidencing residual educational gaps and a need for ongoing education in this space. Disclosures Shulman: Bayer: Consultancy; AMAG: Speakers Bureau; Lupin: Speakers Bureau; Vermillion: Speakers Bureau. Munro:Vifor: Consultancy; Abbvie: Consultancy, Research Funding; American Regent: Consultancy; Boston Scientific: Consultancy; Daiichi Sankyo: Consultancy. Martin:Daiichi Sankyo: Consultancy. Nelson:Merck: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; AMAG: Consultancy; Agile Pharmaceutical: Consultancy, Research Funding; EvoFem: Research Funding; Sebela Pharmaceutica: Consultancy, Research Funding; TherapeuticsMD: Membership on an entity's Board of Directors or advisory committees; American Regent: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Study Objective Heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) often leads to anemia, which may cause fatigue and weakness in affected women. This analysis evaluated clinical improvements in menstrual blood loss (MBL), anemia, and quality of life (QoL) in elagolix-treated women who had HMB, UF, and severe or mild anemia at the time of Elaris UF-1 or UF-2 study entry. Design Pooled subgroup analysis of UF-1 and UF-2, two replicate double-blind, randomized, placebo-controlled, 6-month phase 3 studies. Setting Outpatient. Patients or Participants Subgroup of premenopausal women with HMB (>80mL alkaline hematin-measured MBL/cycle), ultrasound-confirmed UF, and severe (hemoglobin [Hgb] Interventions Elagolix 300mg BID with add-back therapy (estradiol 1mg/norethindrone acetate 0.5mg QD) (elagolix+E2/NETA), compared with placebo. Measurements and Main Results In UF-1 and UF-2, a total of 426/591 (72%) women who received elagolix+E2/NETA or placebo had severe (n=189) or mild anemia (n=237) at study entry. Women with severe anemia had a numerically greater mean baseline MBL (301.6±204.1mL) than women with mild anemia (225.8±128.2mL). Of the elagolix+E2/NETA-treated women with severe anemia at study entry, 74.1% met the study's primary endpoint (had both 2g/dL from baseline to month 6, and 51.1% achieved Hgb≥12g/dL at month 6 (P Conclusion Women with HMB, UF, and severe or mild anemia at study entry demonstrated clinical improvements in MBL, anemia, and QoL with elagolix+E2/NETA treatment.

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.

Study Objective To investigate the utility of a gynecologic laparoscopy simulation curriculum designed for mid-level obstetrics and gynecology (OBGYN) residents in the five Fundamentals of Laparoscopy Surgery (FLS) skills. The hypothesis was that residents would demonstrate significant improvement in all tasks. Design A cohort study. Setting A community based OBGYN residency education program. Patients or Participants A total of 51 2nd and 3rd year residents. Interventions A comprehensive, 10 – week-long gynecologic endoscopy program, comprising both cognitive and manual skills. After an orientation week, formal assessment of baseline time and accuracy for each of the 5 FLS exercises was obtained on each resident by an FLS-certified faculty. Each week thereafter comprised a 3-hour training session with the same faculty that included approximately 90 minutes of hands-on psychomotor training using the FLS Laparoscopic System. All residents had 24 hour a day access to a training facility. On week 9, formal testing was repeated by the same faculty and the data entered into an Excel database. Measurements and Main Results There were 51 residents in the 10-year period and between 38 and 46 pairs of data for the 5 skills were evaluable. The baseline and week 9 completion times in seconds (SD) were as follows: Peg transfer 90.8 (40.1) and 59.4 (20.5); Pattern cut 190.7 (87.9) and 113.8 (51.0); Ligating loop 92.1 (39.6) and 65.1 (31.2); Extracorporeal tie 230.9 (88.3) and 137.8 (42.2); Intracorporeal tie 249.3 (97.9) and 134.1 (69.5). All differences were significant P Conclusion Mid-level OBGYN residents exposed to this gynecologic laparoscopy simulation training program significantly improved performance in the five FLS skills. Consequently, it may serve as a model for residency training programs. However, the absence of a cognitive and psychomotor hysteroscopic component in FLS is noteworthy and a shortcoming for OBGYN training programs.

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.

Study Objective Construct validation of the EMIG Laparoscopic Surgery Simulation System. Design A prospective, controlled cohort comparison. Setting Thirteen teaching institutions in the US and Canada and an AAGL Congress Patients or Participants 221 subjects who fit one of 4 categories of exposure to laparoscopic surgery and surgical simulation: 77 novices within 100 days of starting posgraduate year 1 (PGY-1); 71 within the first 100 days of starting PGY-3; 30 American Board of Obstetrics and Gynecology (ABOG) certified and no additional fellowship training (“Proficient”); 43 who had completed the two-year Fellowship in Minimally Invasive Gynecologic Surgery (FMIGS). Interventions Subjects were oriented to the simulation system and then tested under proctor supervision on the 5 EMIG laparoscopic exercises. These included the sleeve to peg transfer (L-1); the circular pattern cut (L-2); extracorporeal knotting (L-3); intracorporeal knotting (L-4); and a running suture (L-5). Time and accuracy scoring were entered electronically on site, but sessions were video recorded and study materials such as cutting and suturing targets were labeled and stored for subsequent review to optimize data quality. Measurements and Main Results Each exercise was timed, and a number of objective metrics recorded that reflected cutting and suturing accuracy and technique. Each exercise had a “time cap”; if a subject had not completed the exercise by the end of the allotted time, they were categorized “Did Not Complete” and the maximum time was entered for data analysis. Preliminary data analysis demonstrates that the novice group consistently demonstrated the poorest performance and the FMIGS cohort consistently the best. The PGY-3 and “Proficient” cohorts were generally similar to each other but each performed better than the PGY-1 group and well below the FMIGS group. Conclusion The EMIG Laparoscopic Simulation System can be used to distinguish amongst PGY-1, PGY-3, Proficient and FMIGS subjects. FMIGS-trained subjects consistently had the best results with almost no “Did not Complete” outcomes.

Study Objective Evaluate the EMIG-FLS Laparoscopic Simulation System and the EMIG Hysteroscopy Simulation System for face validity and functionality in a pilot testing environment. Design A pilot cohort study Setting Three teaching institutions in the US Southwest Patients or Participants Twenty-seven residents and gynecologists who fit one of three categories of exposure to hysteroscopic and laparoscopic surgery and surgical simulation. Twelve were postgraduate year 1 (PGY-1); five were PGY-3, 1 was ABOG certified, and 5 were either fellows in-training or had completed a Fellowship in Minimally Invasive Gynecologic Surgery (FMIGS). Interventions After completing a screening survey, each subject was exposed to a structured orientation to the two 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 out of 5) and subjects considered instructions to be clear (means ranged 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 amongst 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.

Menstrual symptoms are the commonest gynecologic complaints presenting to health professionals in most cultures, yet it is only very recently that the FIGO Menstrual Disorders Committee developed a pair of systems focusing on more logical and consistent terminologies, definitions and underlying causes relating to menstrual symptoms, signs, and pathologies. These initiatives have resulted in several ill-defined terminologies such as menorrhagia and dysfunctional uterine bleeding (DUB) becoming obsolete. In addition to intermenstrual spotting or bleeding, symptoms of abnormal uterine bleeding (AUB) are now primarily defined by regularity, frequency, duration and volume, and underlying causes are classified by the PALM-COEIN System. Heavy menstrual bleeding (HMB) is the commonest of these “bleeding symptoms” and has the greatest social and physical impacts on women and society, especially through iron deficiency and anemia.

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.

While available evidence shows that diagnostic hysteroscopy can be performed in many patients with little or no analgesia or anesthesia, for some women, there is significant discomfort with the procedure, and many can benefit from the use of local anesthetic techniques. Operative hysteroscopic procedures can also be performed in the office setting, but there are challenges to performing such interventions using local anesthesia. There is little available evidence describing effective anesthetic techniques for operative hysteroscopy, a circumstance that invites both a creative approach and critical evaluation with appropriately rigorous investigation. The uterus possesses at least two distinctly different sources of innervation; the cervix is supplied by S2–4 largely through the uterosacral ligaments while the corpus receives sensory afferents via the T10–L1 roots that access the uterine architecture at the isthmus and via the ovarian ligaments. Theoretically, at least, the strategy for the effective use of local uterine anesthesia must consider these multiple sources of innervation as well as other factors including the procedure to be performed, the instrumentation to be used, selection of appropriate anesthetic agents, and the allowance of adequate elapsed time for a maximal anesthetic effect. An approach utilizing several simultaneously applied techniques is described together with patient pain outcomes suggesting that a wide spectrum of procedures can be performed in an office setting, under local anesthesia.

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.

Historically, the terminology used for abnormal uterine bleeding has been inconsistent and confusing. The Federation Internationale de Gynecologie et d'Obstetrique (FIGO) has recently approved new definitions and a standardized classification system for menstrual disorders and other contributors to the problem of abnormal uterine bleeding. This article describes the need for these changes and aims to encourage their use in routine clinical practice, medical education and scientific research, with the hope that they will lead to improved reproductive healthcare for women.

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 objective of this guideline is to provide clinicians with evidence-based information about commonly used and available hysteroscopic distending media to guide them in their performance of both diagnostic and operative hysteroscopy. While necessary for the performance of hysteroscopy and hysteroscopically-directed procedures, distending media, if absorbed systemically in sufficient amounts, can have associated adverse events, including life-threatening complications. Consequently, understanding the physical properties and the potential risks associated with the use of the various distending media is critical for the safe performance of hysteroscopic procedures. This report was developed under the direction of the Practice Committee of the AAGL as a service to their members and other practicing clinicians.

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.