Levels of Gynecologic Care: A Task Force Consensus Statement.

Systems of care have been established for obstetrics, trauma, and neonatology. An American College of Obstetricians and Gynecologists Presidential Task Force was established to develop a care system for gynecologic surgery. A group of experts who represent diverse perspectives in gynecologic practice proposed definitions of levels of gynecologic care using the Delphi method. The goal is to improve the quality of gynecologic surgical care performed in the United States by providing a framework of minimal institutional requirements for each level. Subgroups developed draft criteria for each level of care. The entire Task Force then met to reach consensus regarding the levels of care final definitions and parameters. The levels of gynecologic care framework focuses on systems of care by considering institutional resources and expertise, providing guidance on the provision of care in appropriate level facilities. These levels were defined by the ability to care for patients of increasing risk, complexity, and comorbidities, organizing gynecologic care around hospital capability. This framework can also be used to inform the escalation of care to appropriate facilities by identifying patients at risk and guiding them to facilities with the skills, expertise, and capabilities to safely and effectively meet their needs. The levels of gynecologic care framework is intended for use by patients, hospitals, and clinicians in the United States to guide where elective surgery can be done most safely and effectively by specialists and subspecialists in obstetrics and gynecology. The key features of the levels of gynecologic care include ensuring provision of risk-appropriate care and regionalization of care by facility capabilities.

Preoperative Hematocrit Level and Associated Risk of Transfusion for Myomectomy Based on Myoma Burden and Surgical Route.

STUDY OBJECTIVE: To determine the association between preoperative hematocrit level and risk of blood transfusion for laparotomic and laparoscopic myomectomy based on myoma burden and surgical route. DESIGN: A cohort study of prospectively collected data. SETTING: American College of Surgeons National Surgical Quality Improvement Program participating institutions. PATIENTS: A total of 26 229 women who underwent a laparotomic or laparoscopic myomectomy from 2010 to 2020. INTERVENTIONS: The primary outcome assessed was the risk of transfusion based on preoperative hematocrit level. This was evaluated with respect to myoma burden and surgical route. MEASUREMENTS AND MAIN RESULTS: There were 26 229 women who underwent a myomectomy during the study interval, 2345 women (9%) of whom required a blood transfusion. Compared with patients who did not require transfusion, those who did had lower median preoperative hematocrit levels (34.7 vs 38.2). Patients were stratified by surgical approach (laparotomic vs laparoscopic) and myoma burden (1-4 myomas/weight ≤250 g or ≥5 myomas/weight >250 g) using Current Procedural Terminology codes (58140, 58146, 58545, 58546). In all categories, there was an inverse relationship between blood transfusion and preoperative hematocrit level with increasing risk depending on preoperative hematocrit range. The odds ratios comparing hematocrit level of 29% with 39% were 6.16 (95% confidence interval [CI], 5.15-7.36), 4.92 (95% CI, 4.19-5.78), 4.85 (95% CI, 3.72-6.33), and 5.2 (95% CI, 3.63-7.43) for patients with laparotomic (1-4 myomas/≤250 g, ≥5 myomas/>250 g) and laparoscopic myomectomy (1-4 myomas/≤250 g, 5 myomas/>250 g), respectively. CONCLUSION: Incremental increases in hematocrit result in a significantly decreased risk of blood transfusion at the time of myomectomy.

Endometrial Cryoablation for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the CLARITY Study.

Study Objective: To examine long-term outcomes from the pivotal study that evaluated the safety and effectiveness of the Cerene® Cryotherapy Device (Channel Medsystems, Berkeley, CA) in premenopausal women with heavy menstrual bleeding due to benign causes who have completed childbearing. Methods: The prospective, multicenter, single-arm, open-label study had eight sites in the USA, one in Mexico, and two in Canada. Inclusion criteria included uterine sound ≤10 cm, endometrial cavity length 2.5 to 6.5 cm, age 25 to 50 years, a pictorial blood loss assessment chart score of ≥150, no submucosal myomata and/or uterine obstruction, distortion, or abnormality. A total of 242 subjects underwent a 2.5-minute cryoablation. Long-term follow-up visits were conducted at Month 24 and Month 36. Data collected included gynecological adverse events, description of last menstrual period, contraception status, self-report of pregnancy, medical or surgical interventions to treat abnormal uterine bleeding, satisfaction, recommendation, and quality of life (QoL). QoL outcomes were measured with the Menorrhagia Impact Questionnaire (MIQ) and the Premenstrual Symptoms Impact Survey (PMSIS™). Results: 201 subjects completed their Month 36 final study visit. Subject outcomes were comparable to those at Month 12. Eighty-nine percent of subjects reported amenorrhea, a lighter-than-normal, or normal period, 91% of subjects had no or slight limitations in MIQ measured activities, and 85% reported premenstrual symptoms at a low frequency. Eighty-five percent of the subjects were satisfied or very satisfied. The cumulative incidence of hysterectomy was 5% and reintervention was 8.7%. Forty-nine gynecologic adverse events (AE) were reported; one non-serious AE, postcoital bleeding, was reported as related to the procedure. No serious device-related or procedure-related AEs were reported. Conclusion: Study data demonstrate that the positive effects of Cerene Cryotherapy Device treatment are sustained through Month 36 and that the risks associated with the device and procedure are low (ClinicalTrials.gov; NCT02842736).

Should body mass index replace age to drive the decision for endometrial sampling in premenopausal women with abnormal uterine bleeding?

OBJECTIVE: This study aimed to evaluate risk factors for endometrial intraepithelial neoplasia/malignancy in premenopausal women with abnormal uterine bleeding or oligomenorrhea. Specifically, we aimed to elucidate whether body mass index (BMI) or age confers a higher risk. STUDY DESIGN: A retrospective cohort study was performed at a large academic center examining risk factors for endometrial hyperplasia/malignancy in premenopausal women undergoing endometrial sampling. RESULTS: Of the 4170 women ages 18-51 who underwent endometrial sampling from 1987 to 2019, 77 (1.85%) were found to have endometrial intraepithelial neoplasia or malignancy. Clinical predictors of EIN/malignancy in this population included obesity (OR: 3.84, 95%, p < .001), Body mass index [(OR30 vs. 25:2.11, p < .001) and OR35 vs. 30: 1.65, p < .001], Diabetes (OR: 3.6, p-value <.001), hormonal therapy use (OR: 2.93, p < .001), personal history of colon cancer (OR: 9.90, p = .003), family history of breast cancer (OR: 2.65, p < .001), family history of colon cancer (OR: 3.81, p < .001), and family history of endometrial cancer (OR: 4.92, p = .033). Age was not significantly associated with an increased risk of disease. Adjusting for other factors, a model using BMI to predict the risk of EIN/malignancy was more discriminative than a model based on age. CONCLUSIONS: Increased BMI, may be more predictive of endometrial hyperplasia/malignancy than age in premenopausal women with abnormal uterine bleeding. Modification of evaluation guidelines in a contemporary demographic setting could be considered.

Hysteroscopic Access and Uterine Cavity Evaluation 12 Months after Endometrial Ablation with the Cerene Cryotherapy Device.

STUDY OBJECTIVE: To evaluate whether physical access and the ability to systematically assess the postablation uterine cavity were preserved at 12 months after endometrial ablation with the Cerene cryotherapy device (ChannelMedsystems, Emeryville, CA). DESIGN: A prospective, multicenter, single-arm study. SETTING: In the clinic at 8 US sites and outpatient hospital setting at 2 sites in Canada and 1 site in Mexico. PATIENTS: A total of 230 (of 242) subjects continued in the study at the Month 12 visit after ablation. Two hundred twenty-three subjects were available for a diagnostic hysteroscopic evaluation. INTERVENTIONS: Subjects who had previously been treated with a 2.5-minute cryoablation of the endometrium utilizing the Cerene device underwent a diagnostic hysteroscopy at the Month 12 follow-up visit. MEASUREMENTS AND MAIN RESULTS: The uterine cavity was accessible in 220 of 223 subjects (98.7%) and not accessible in 3 (1.3%) because of pain (n = 2) and cervical stenosis (n = 1). Visualization of the uterine cavity was possible in 204 of 220 subjects (92.7%) with one or both tubal ostia identified in 89.2% (182 of 204) of subjects. Both tubal ostia were visible in 160 of 204 subjects (78.4%) and one ostium in 22 of 204 subjects (10.8%). The cavity was not visualized in the remaining 16 of 220 subjects (7.2%) because of intrauterine adhesions (n = 14), technical difficulties (n = 1), or menstruation (n = 1). In 95.6% (195 of 204) of subjects where the cavity was visualized, the hysteroscopic view was judged adequate to evaluate the uterine cavity for pathologic change. No significant complications occurred during the hysteroscopic evaluations. CONCLUSION: This is the largest study to date conducted to hysteroscopically evaluate the postablation uterine cavity. Uterine cavity assessment with in-office hysteroscopy 1 year after the use of the Cerene cryotherapy device is attainable, enabling both diagnostic and therapeutic procedures within the endometrial cavity.

A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding.

STUDY OBJECTIVE: To evaluate the safety and effectiveness of a novel cryoablation device (Cerene Cryotherapy Device, Channel Medsystems, Emeryville, CA) in premenopausal women with heavy menstrual bleeding owing to benign causes. DESIGN: A prospective, multi-center, single-arm, open label, non-randomized study. SETTING: At 11 academic and private practices in North America: 8 clinic sites in the United States, and 3 outpatient hospital sites (1 in Mexico and 2 in Canada). PATIENTS: A total of 242 subjects comprise the intent-to-treat population. Subject demographics were similar to other published endometrial ablation studies performed. INTERVENTIONS: Subjects were treated with a single-use disposable cryoablation device (Cerene) which delivers a 2.5-minute treatment to the endometrium. Analgesia and local anesthesia were administered per investigator discretion; intravenous sedation was used in only 3% of subjects and no general anesthesia was used. MEASUREMENTS AND MAIN RESULTS: There were no device or procedure-related serious adverse events, nor unanticipated adverse device effects. Cerene cryoablation was effective in reducing menstrual blood loss, which was measured by pictorial blood loss assessment chart (PBLAC) score. Mean score dropped from 360.6 at pretreatment (±332.1) to 51 at 12 months posttreatment (±64.1), with 81% of 230 evaluable subjects reporting a PBLAC score of ≤75 and 85% of evaluable subjects reporting a PBLAC score of ≤ 100. The median pain rating was ≤2 (mild) throughout the treatment. Of 223 subjects that underwent hysteroscopic evaluation at 12 months, the uterine cavity was visualized in 220 subjects. Quality of life improved with 90% of reporting subjects indicating satisfied or very satisfied at month 12. CONCLUSION: This study demonstrated that Cerene cryoablation is safe and effective, offering the benefits of reduced menstrual blood loss with limited use of pain medication, high patient tolerability, quality of life improvement, and preserved access to the uterine cavity.

A Novel Robotic Endoscopic Device Used for Operative Hysteroscopy.

To trial the use of a novel endoscopic robot that functions using concentric tube robots, enabling 2-handed surgery in small spaces, in a bioengineering laboratory. This was a feasibility study of the endoscopic robot for hysteroscopic applications, including removal of a simulated endometrial polyp. The endoscopic robot was successfully used to resect a simulated endometrial polyp from a porcine uterine tissue model in a fluid environment. The potential advantages of this platform to the surgeon may include improved exposure, finer dissection capability, and use of a 2-handed surgical technique. Further study regarding the safe, efficient, and cost-effective use of the endoscopic robot in gynecology is needed.

Enhanced recovery after surgery in minimally invasive gynecologic surgery surgical patients: one size fits all?

PURPOSE OF REVIEW: Enhanced recovery after surgery (ERAS) programs aim to expedite functional recovery and improve surgical outcomes without increasing complications or cost. First championed by colorectal surgeons, ERAS protocols are now widely utilized among surgical subspecialties. The present review focuses on use of ERAS pathways in minimally invasive gynecologic surgery (MIGS) and risk factors for suboptimal outcomes in this population. RECENT FINDINGS: Studies across multiple fields has shown benefit to adoption of ERAS protocols. However, lack of protocol standardization among institutions, implementation of interventions as a bundle, varied compliance, and lack of study randomization collectively obscure generalizability of findings from such studies. Emerging data in fact suggest benefits may not translate equally across all populations, cautioning against indiscriminate application of protocols to all surgeries or patients. Thus applicability of ERAS protocols to the MIGS population merits close examination. SUMMARY: ERAS protocols improve postoperative outcomes, satisfaction, and cost of care for most patients undergoing gynecologic surgery. However, modifications to typical ERAS protocols may be beneficial to certain subsets of patients including patients with chronic pelvic pain, opiate dependence, or psychiatric disorders. Identification of risk factors for admission or increased hospital stay may help guide protocol modifications for at-risk groups within the MIGS population.

Surgical Competency for Robot-Assisted Hysterectomy: Development and Validation of a Robotic Hysterectomy Assessment Score (RHAS).

STUDY OBJECTIVE: To develop and validate a procedure-specific scoring algorithm to objectively measure robotic surgical skills during robot-assisted hysterectomy and to facilitate robotic surgery training and education. DESIGN: (Canadian Task Force classification III). SETTING: A National Comprehensive Cancer Network-designated comprehensive cancer center. PATIENTS: Deidentified videos for robot-assisted hysterectomies were evaluated. INTERVENTIONS: Videos from 26 robotic hysterectomies performed by surgeons with varying degrees of experience using the scoring system were evaluated. In phase I, critical elements of a robotic hysterectomy were deconstructed into 6 key domains to assess technical skills for procedure completion. Anchor descriptions were developed for each domain to match a 5-point Likert scale. Delphi methodology was used for content validation. A panel of 5 expert robotic surgeons refined this scoring system. In phase II, video recordings of procedures performed by surgeons with varying degrees of experience (expert, advanced beginner, and novice) were evaluated by blinded expert reviewers using the scoring system. Descriptive statistics were used to summarize the scores for each domain. Intraclass correlation was used to determine the interrater reliability. A p value <.05 was considered significant. MEASUREMENTS AND MAIN RESULTS: The average score for the 3 classes of surgeon was 75.6 for expert, 71.3 for advanced beginner, and 69.0 for novice (p = .006). There were significant differences in scores of most individual domains among the various classes of surgeons. Novice surgeons took significantly longer than expert surgeons to complete their half of a hysterectomy (22.2 vs 12.0 minutes; p = .001). CONCLUSION: This pilot study demonstrates the feasibility of using a standardized rubric for clinical skills assessment in robotic hysterectomy. Blinded expert reviewers were able to differentiate between varying levels of surgical experience using this assessment tool.

Gynecologic Surgery in the Pediatric and Adolescent Populations: Review of Perioperative and Operative Considerations.

Gynecologists are often consulted on pediatric and adolescent patients who may require a surgical treatment for a gynecologic diagnosis. This patient population can present an interesting challenge for a nonpediatrician. It is helpful to review the differences in anatomy, alterations in drug dosing, surgical limitations, and counseling and consent requirements in this patient population before proceeding with a surgical treatment. This is a review of preoperative, intraoperative, and postoperative considerations for gynecologic surgery in the pediatric and adolescent patient population.

Intracorporeal electromechanical tissue morcellation: a critical review and recommendations for clinical practice.

Electromechanical morcellators have come under scrutiny with concerns about complications involving iatrogenic dissemination of both benign and malignant tissues. Although the rapidly rotating blade has resulted in morcellator-related vascular and visceral injuries, equally concerning are the multiple reports in the literature demonstrating seeding of the abdominal cavity with tissue fragmented such as leiomyomas, endometriosis, adenomyosis, splenic and ovarian tissues, and occult cancers of the ovaries and uterus. Alternatives to intracorporeal electric morcellation for tissue extirpation through the vagina and through minilaparotomy are feasible, safe, and have been shown to have comparable, if not superior, outcomes without an increased need for laparotomy. Intracorporeal morcellation within a containment bag is another option to minimize the risk of iatrogenic tissue seeding. Patient safety is a priority with balanced goals of maximizing benefits and minimizing harm. When intracorporeal electromechanical morcellation is planned, physicians should discuss the risks and consequences with their patients. Although data are being collected to quantify and understand these risks more clearly, a minimally invasive alternative to unenclosed intracorporeal morcellation is favored when available. It is incumbent on surgeons to communicate the risks of practices and devices and to advocate for continued improvement in surgical instrumentation and techniques.

Hysteroscopic sterilization success in outpatient vs office setting is not affected by patient or procedural characteristics.

STUDY OBJECTIVE: To determine factors associated with hysteroscopic sterilization success and whether it differs between the operating room and office settings. DESIGN: Retrospective cohort analysis (Canadian Task Force classification II-2). SETTING: Major university medical center. PATIENTS: Six hundred thirty-eight women who underwent hysteroscopic sterilization between July 1, 2005, and June 30, 2011. MEASUREMENTS AND MAIN RESULTS: Data collected included age, body mass index, previous office procedures, previous cesarean section, and presence of myomas or retroverted uterus. Place of surgery, experience of surgeon, insurance type, bilateral device placement, compliance with hysterosalpingography, and confirmation of occlusion were also recorded. Bivariate analysis of patient characteristics between groups was performed using χ(2) and independent t tests, and identified confounders and associated variables. Multivariate analysis was performed using logistic regression to assess for association and to adjust for confounders. Procedures were performed in the operating room (57%) or in the office (43%). There was no association between success in bilateral device placement or occlusion and any patient characteristic, regardless of surgery setting. Private insurance, patient age, and performance of procedures in the office setting were positively associated with likelihood of compliance with hysterosalpingography. CONCLUSION: Successful device placement and tubal occlusion are independent of patient age, body mass index, or setting of the procedure. Association between insurance type and completing hysterosalpingography illustrates an important public health problem. Patients who fail to undergo hysterosalpingography to confirm tubal occlusion may unknowingly be at risk of pregnancy and increased risk of ectopic pregnancy.

Predicting pelvic pain after endometrial ablation: which preoperative patient characteristics are associated?

STUDY OBJECTIVE: To determine which patient characteristics are associated with an increased risk of postablation pelvic pain. DESIGN: Canadian Task Force classification II-2. METHODS: Data were collected from a retrospective cohort of patients who underwent endometrial ablation between January 2006 and September 2010 at a large academic medical center. Patients were identified via Current Procedural Terminology codes (58563, 58353, and 58356) for any type of endometrial ablation (rollerball or global); the sample size was 437 women. Multiple conditions and comorbidities were recorded for each patient. Bivariate analysis of patient demographics and the incidence of pain after endometrial ablation were evaluated using the chi square, Fisher exact, and independent t tests where appropriate. A final multivariate analysis with logistic regression was conducted to determine the exact patient characteristics that are associated with pelvic pain after endometrial ablation. RESULTS: Of 437 women who underwent endometrial ablation, 20.8% reported pain after their ablation. Patients were followed for up to 6.5 years postablation with a median follow-up of 794 days. The median number of days for the development of pain after ablation was 301 days, with 75% of patients who developed pain reporting it within approximately 2 years of their procedure. The median time to hysterectomy for those with pain was 570 days. Other postablation treatments included hormonal therapies in 9.4% of the total population. A total of 20.8% of patients reported postablation pelvic pain, but only 6.3% underwent subsequent hysterectomy for that indication. Preablation patient characteristics significantly associated with the development of postablation pain include dysmenorrhea (aOR = 1.73), smoking status (aOR = 2.31), prior tubal ligation (aOR = 1.68), and age less than 40 (aOR 1.90). Although not statistically significant, a diagnosis of endometriosis appears to be related to postablation pain (aOR = 2.24). Adenomyosis (suggested on ultrasound) and body mass index associations were not statistically significant. A patient with all 4 risk factors for postablation pain (i.e., dysmenorrhea, smoking, prior tubal ligation, and <40 years old) has a 53% (95% confidence interval, 0.40-0.66) chance of experiencing postablation pain. CONCLUSION: The observed incidence of pelvic pain is 20.8% after endometrial ablation and is more frequently observed in women with preablation dysmenorrhea, tobacco use, prior tubal ligation, age less than 40, and possibly endometriosis. One should consider these preexisting conditions when counseling patients regarding outcome expectations after an endometrial ablation procedure.

The Adiana System for permanent contraception: safety and efficacy at 3 years.

STUDY OBJECTIVE: To evaluate the efficacy of the Adiana System for preventing pregnancy in women desiring permanent sterilization. DESIGN: This study is a prospective, single-arm, multicenter, international trial. The primary endpoint was pregnancy prevention rate at 12 months. Pregnancy prevention rates at 24 and 36 months were also calculated (Canadian Task Force classification II-2). SETTING: The study was conducted at 16 sites, 14 in the United States, 1 in Australia, and 1 in Mexico. PATIENTS: A total of 645 women (intent-to-treat group). INTERVENTION: Hysteroscopic placement of polymer matrix was attempted in all patients. Tubal occlusion confirmed by hysterosalpingography at 12 weeks. Ongoing monitoring for pregnancy over 36 months. MEASUREMENTS AND MAIN RESULTS: There was a 95% bilateral matrix placement rate and 88.4% bilateral occlusion by hysterosalpingography, as previously reported. A total of 24 968 person-months of wearing were accrued. Pregnancy prevention rates were summarized with descriptive statistics by use of 95% two-sided confidence interval on the basis of life-table methods. Complete 36-month data were available for 481 subjects. During the first year, 6 pregnancies were reported. Three were determined to be the result of misinterpretation of hysterosalpingography results. The remaining 3 were attributed to method failure, as were the 3 pregnancies during the second year. No additional pregnancies occurred in year 3. The cumulative pregnancy prevention rates at 12, 24, and 36 months compare favorably with data from the Collaborative Review of Sterilization study and other published reports documenting efficacy of established permanent sterilization procedures. CONCLUSIONS: These data demonstrate that the efficacy of the Adiana System for pregnancy prevention is similar to other permanent sterilization methods.

Hysteroscopic sterilization in patients with a Mirena intrauterine device: transition from extended interval to permanent contraception.

OBJECTIVE: To estimate the feasibility and elucidate the benefits of performing hysteroscopic sterilization in patients who have a Mirena intrauterine device (IUD) in place. DESIGN: Retrospective case-controlled study with 3:1 ratio (Canadian Task Force Classification II-2). SETTING: Procedures were performed in an outpatient or office setting affiliated with an academic medical center. Hysterosalpingograms were obtained and interpreted jointly by an investigator and a radiologist using standard protocol. PATIENTS: Subjects included all patients undergoing hysteroscopic sterilization July 2007 thru December 2008 with a Mirena IUD in place. Patients without an IUD served as a comparison group. INTERVENTIONS: All procedures were performed with a 4.2-mm Bettocchi continuous-flow hysteroscope with saline solution insufflation. Delivery catheters were passed through a 5F operative channel. Essure implants were positioned and released per standard protocol. IUD devices were removed after confirmation of bilateral tubal occlusion. MEASUREMENTS & MAIN RESULTS: There were 12 patients currently using a Mirena IUD for contraception who elected to undergo hysteroscopic sterilization. Procedures were performed in the usual manner. Chart review identified the most recently treated patients without an IUD in place matched for age and body mass index to study patients. Recorded details included age, body mass index, parity, procedure time, placement success, and tubal occlusion. There were no significant differences between the groups with respect to any metric except completion of the 3- month hysterosalpingogram. CONCLUSION: Hysteroscopic sterilization can be performed successfully with a Mirena IUD in place. Advantages include flexibility in timing of the procedure, assurance of contraception until confirmation of tubal occlusion, and increased likelihood of appropriate follow-up.