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.

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.

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.

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.

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.

Microwave endometrial ablation vs. rollerball electroablation for menorrhagia: a multicenter randomized trial.

STUDY OBJECTIVE: To compare the effectiveness, safety, and acceptability of microwave endometrial ablation (MEA) with those of rollerball electroablation (REA) for the treatment of menorrhagia. DESIGN: Randomized clinical trial (Canadian Task Force classification I). SETTING: Eight academic medical centers and private medical practices. PATIENTS: Three hundred twenty-two women with documented menorrhagia due to benign causes. INTERVENTION: MEA or REA. MEASUREMENTS AND MAIN RESULTS: By intent-to-treat analysis, the success rate of MEA at 12 months (87.0%; CI 81.7%-91.2%) did not differ significantly (p = .40) from that of REA (83.2%; CI 74.7%-89.7%). Among evaluable patients, success rate was also similar (p = .24) in the MEA (96.4%; CI 92.7%-98.5%) and REA (92.7%; CI 85.6%-97%) groups. The amenorrhea rate in evaluable patients after MEA was 61.3% (CI 54.1 %-68.2%). In patients with myomas, the success and amenorrhea rates in evaluable patients after MEA were 90.3% (CI 74.2%-98%) and 61.3% (CI 42.2%-78.2%), respectively. In evaluable patients with body mass index of 30 kg/m2 or greater, MEA success rate was 96.7% (CI 88.5%-99.6%) compared with 81.8% (CI 59.7%-94.8%) for REA (p = .042). The ablation procedure was performed under IV sedation in 62% of patients in the MEA group versus 18% of patients in the REA group (p <.001); whereas, general anesthesia was employed more often in patients undergoing REA (37% vs. 76%, p <.001). No major complications were encountered. Patient satisfaction with results of treatment was high (98.5% of the MEA and 99.0% of the REA group). CONCLUSIONS: Microwave endometrial ablation is an efficacious and safe procedure for the treatment of menorrhagia. Over half of patients treated with MEA achieve amenorrhea, and the procedure is suitable for women with myomas and irregular uterine cavities. The procedure is easily learned and can be performed rapidly, under IV sedation in most cases.