Favorable surgical and obstetrical outcomes in pre- and postconceptional laparoscopic abdominal cerclage: a large multicenter cohort study.

BACKGROUND: Cervical incompetence is an important cause of extremely preterm delivery. Without specialized treatment, cervical incompetence has a 30% chance of recurrence in a subsequent pregnancy. Recently, the first randomized controlled trial showed significant superiority of abdominal cerclage compared with both high and low vaginal cerclage in preventing preterm delivery at <32 weeks of gestation and fetal loss in patients with a previous failed vaginal cerclage. OBJECTIVE: This study aimed to assess surgical and obstetrical outcomes in patients with pre- and postconceptional laparoscopic abdominal cerclage placement. Furthermore, it also aimed to perform subgroup analysis based on the indication for cerclage placement in order to identify patients who benefit the most from an abdominal cerclage. STUDY DESIGN: A retrospective multicenter cohort study with consecutive inclusion of all eligible patients from 1997 onward in the Dutch cohort (104 patients) and from 2007 onward in the Boston cohort (169 patients) was conducted. Eligible patients had at least 1 second- or third-trimester fetal loss due to cervical incompetence and/or a short or absent cervix after cervical surgery. This includes loop electrosurgical excision procedure, conization, or trachelectomy. Patients were divided into the following subgroups based on the indication for cerclage placement: (1) previous failed vaginal cerclage, (2) previous cervical surgery, and (3) other indications. The third group consisted of patients with a history of multiple second- or early third-trimester fetal losses due to cervical incompetence (without a failed vaginal cerclage) and/or multiple dilation and curettage procedures. The primary outcome measure was delivery at ≥34 weeks of gestation with neonatal survival at hospital discharge. Secondary outcome measures included surgical and obstetrical outcomes, such as pregnancy rates after preconceptional surgery, obstetrical complications, and fetal survival rates. RESULTS: A total of 273 patients were included (250 in the preconceptional and 23 in the postconceptional cohort). Surgical outcomes of 273 patients were favorable, with 6 minor complications (2.2%). In the postconceptional cohort, 1 patient (0.4%) had hemorrhage of 650 mL, resulting in conversion to laparotomy. After preconceptional laparoscopic abdominal cerclage (n=250), the pregnancy rate was 74.1% (n=137) with a minimal follow-up of 12 months. Delivery at ³34 weeks of gestation occurred in 90.5% of all ongoing pregnancies. Four patients (3.3%) had a second-trimester fetal loss. The indication for cerclage in all 4 patients was a previous failed vaginal cerclage. The other subgroups showed fetal survival rates of 100% in ongoing pregnancies, with a total fetal survival rate of 96%. After postconceptional placement, 94.1% of all patients with an ongoing pregnancy delivered at ³34 weeks of gestation, with a total fetal survival rate of 100%. Thus, second-trimester fetal losses did not occur in this group. CONCLUSION: Pre- and postconceptional laparoscopic abdominal cerclage is a safe procedure with favorable obstetrical outcomes in patients with increased risk of cervical incompetence. All subgroups showed high fetal survival rates. Second-trimester fetal loss only occurred in the group of patients with a cerclage placed for the indication of previous failed vaginal cerclage, but was nevertheless rare even in this group.

Diagnosis of gynecologic malignancy after the treatment of presumed benign fibroid disease with interventional radiology procedures: a retrospective cohort study.

OBJECTIVE: To ascertain the finding of future diagnosis of malignancy in women who undergo nonsurgical treatment for uterine fibroid disease with interventional radiology (IR) procedures. DESIGN: Mixed-methods retrospective cohort study. SETTING: Two tertiary care academic hospitals in Boston, Massachusetts. PATIENT(S): A total of 491 women who underwent radiologic intervention for fibroids between 2006 and 2016. INTERVENTION(S): Uterine artery embolization or high-intensity focused ultrasound ablation. MAIN OUTCOME MEASURE(S): Subsequent surgical interventions and diagnosis of gynecologic malignancy after the IR procedure. RESULT(S): During the study period, 491 women underwent treatment of fibroids with IR procedures; follow-up information was available for 346 cases. The mean age was 45.3 ± 4.8 years, and 69.7% were between the ages of 40 and 49 years. Regarding ethnicity, 58.9% of patients were white, and 26.1% were black. The most common symptoms were abnormal uterine bleeding (87%), pelvic pressure (62.3%), and pelvic pain (60.9%). A total of 106 patients underwent subsequent surgical treatment of fibroids. Of the 346 patients who had follow-up, 4 (1.2%) were diagnosed with leiomyosarcoma after their interventional treatment for fibroids. An additional 2 cases of endometrial adenocarcinoma and 1 case of a premalignant lesion of the endometrium were noted. CONCLUSION(S): The proportion of patients who went on to be diagnosed with leiomyosarcoma after conservative IR treatments appears to be higher than previously reported. A thorough preprocedural workup and patient counseling regarding the possibility of underlying uterine malignancy should be undertaken.

Uterine rupture and factors associated with adverse outcomes.

PURPOSE: To review cases of uterine rupture and identify risk factors associated with adverse outcomes. METHODS: This study is a retrospective cohort of complete uterine ruptures diagnosed in a large hospital system in Massachusetts between 2004 and 2018. Baseline demographics, labor characteristics and outcomes of uterine rupture were collected from medical records. RESULTS: A total of 173 cases of uterine rupture were identified. There were 30 (17.3%) women with an unscarred uterus, while 142 (82.1%) had a scarred uterus. Adverse outcomes (n = 89, 51.4% of cases) included 26 (15.0%) hysterectomies, 55 (31.8%) blood transfusions, 18 (10.4%) bladder/ureteral injuries, 5 (2.9%) reoperations, 25 (14.5%) Apgar scores lower than 5 at 5 min and 9 (5.2%) perinatal deaths. Uterine rupture of a scarred uterus was associated with decreased risk of hemorrhage (OR 0.40, 95% CI 0.17-0.93), blood transfusion (OR 0.27, 95% CI 0.11-0.69), hysterectomy (OR 0.23, 95% CI 0.08-0.69) and any adverse outcome (OR 0.34, 95% CI 0.13-0.91) compared with unscarred rupture. Uterine rupture during vaginal delivery was associated with increased risk of transfusion (OR 6.55, 95% CI 1.53-28.05) and hysterectomy (OR 8.95, 95% CI 2.12-37.72) compared with emergent C-section. CONCLUSIONS: Although rare, uterine rupture is associated with adverse outcomes in over half of cases. Unscarred rupture and vaginal delivery demonstrate increased risk of adverse outcomes, highlighting the need for early diagnosis and operative intervention.

Very Low Rates of Ureteral Injury in Laparoscopic Hysterectomy Performed by Fellowship-trained Minimally Invasive Gynecologic Surgeons.

STUDY OBJECTIVE: The objective of this case series is to evaluate the rates of ureteral injury at the time of laparoscopic hysterectomy among high-volume fellowship-trained surgeons. DESIGN: A retrospective chart review was performed, evaluating laparoscopic hysterectomy cases between 2009 and 2019 performed exclusively by fellowship-trained surgeons. SETTING: Division of Minimally Invasive Gynecologic Surgery (MIGS) at the Brigham and Women's Hospital and Brigham and Women's Faulkner Hospital, a Harvard Medical School teaching hospital in Boston. PATIENTS: All patients undergoing laparoscopic hysterectomy by one of 5 surgeons with fellowship training in MIGS. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 5160 cases were handled by MIGS surgeons between 2009 and 2019 at our institution. Of these cases, 2345 were laparoscopic hysterectomy cases with available intraoperative and postoperative documentation. Most patients had undergone previous surgeries, and the most common indications for hysterectomy included uterine myomas, pelvic pain/endometriosis, and abnormal uterine bleeding. At the time of hysterectomy, 1 ureteral injury (0.04%) was noted. No additional delayed ureteral injuries were observed. Most patients were discharged home the same day (64.9%) and did not have any postoperative complications (63.9%) as designated by the Clavien-Dindo classification. CONCLUSION: Ureteral injury, although rare, is more prevalent in gynecologic surgery than in other surgical disciplines that have some focus on the pelvis. No study to date has evaluated the effect of surgical training and volume on rates of ureteral injuries. This study retrospectively examined ureteral injury rates for one group of high-volume fellowship-trained surgeons and found their rates to be lower than the national average. Proposals are presented for optimizing training and delivery of gynecologic surgical care to minimize complications.

Analysis of COVID-19 Response and Impact on Gynecologic Surgery at a Large Academic Hospital System.

BACKGROUND AND OBJECTIVES: The COVID-19 pandemic dramatically impacted gynecologic surgery. In March 2020, the American College of Surgeons recommended delay of all nonessential invasive procedures. This study characterizes the number and types of procedures performed during the peak pandemic. METHODS: A retrospective cohort study was performed. All patients undergoing gynecological surgery at a large academic hospital system from March 16, 2019 to July 31, 2019 and from March 16, 2020 to July 31, 2020 were evaluated. Data was stratified by three time periods corresponding to state and hospital policy changes. During period 1, no nonessential procedures were advised. During period 2, urgent procedures resumed. During period 3, full surgical reopening was achieved. RESULTS: In 2019, 1,545 gynecologic cases were performed compared with 942 cases in 2020 (39.0% decrease). There was a 73.6% decrease in cases over period 1, a 20.1% decrease over period 2, and a 2.9% increase over period 3. Cases performed by gynecologic oncologists in 2020 accounted for 58.1% of all gynecologic cases over period 1, 29.4% of cases over period 2, and 33.3% of cases over period 3. In 2020, hysterectomy was the most commonly performed procedure, while surgery for endometriosis and uterine fibroids had the greatest decrease in volume. Among emergency procedures, more surgery for ectopic pregnancy was performed in 2020 compared with 2019. CONCLUSION: Many patients had significant delays in receiving gynecologic surgical care during the peak pandemic period. Further studies are indicated to determine the impact of delayed care on patients' quality of life and disease process.

Superior Hypogastric Plexus Block to Reduce Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial.

OBJECTIVE: To assess whether a superior hypogastric plexus block performed during laparoscopic hysterectomy reduces postoperative pain. METHODS: We conducted a multicenter, randomized, single-blind, controlled trial of superior hypogastric plexus block at the start of laparoscopic hysterectomy. Women undergoing a laparoscopic hysterectomy for any indication and with any other concomitant laparoscopic procedure were eligible. Standardized preoperative medications and incisional analgesia were provided to all patients. Our primary outcome was the proportion of patients with a mean visual analog scale (VAS) pain score lower than 4 within 2 hours postoperatively. Patients but not surgeons were blinded to the treatment group. Twenty-nine patients per group was estimated to be sufficient to detect a 38% absolute difference in the proportion of patients with a VAS score lower than 4 at 2 hours postoperatively, with 80% power and an α of 0.05. To account for loss to follow-up and potential imbalances in patient characteristics, we planned to enroll 50 patients per group. All analyses were intention to treat. RESULTS: Between January 2018 and February 2019, 186 patients were eligible; 100 were randomized and analyzed. Demographic and clinical characteristics were similar between the two groups. There was no significant difference in the proportion of patients with a mean VAS score lower than 4 within 2 hours postoperatively between patients who received a superior hypogastric plexus block (57%) and patients who did not (43%) (odds ratio 1.63, 95% CI 0.74-3.59; adjusted odds ratio 1.84, 95% CI 0.75-4.51). CONCLUSION: Among patients undergoing laparoscopic hysterectomy with standardized enhanced perioperative recovery pathways, superior hypogastric plexus block did not significantly reduce postoperative pain. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03283436.

Risk-prediction Model for Patients Undergoing Laparoscopic Hysterectomy.

STUDY OBJECTIVE: Develop a model for predicting adverse outcomes at the time of laparoscopic hysterectomy (LH) for benign indications. DESIGN: Retrospective cohort study. SETTING: Large academic center. PATIENTS: All patients undergoing LH for benign indications at our institution between 2009 and 2017. INTERVENTIONS: LH (including robot-assisted and laparoscopically assisted vaginal hysterectomy) was performed per standard technique. Data about the patient, surgeon, perioperative adverse outcomes (intraoperative complications, readmission, reoperation, operative time >4 hours, and postoperative medical complications or length of stay >2 days), and uterine weight were collected retrospectively. Pathologic uterine weight was used as a surrogate for predicted preoperative uterine weight. The sample was randomly split, using a random sequence generator, into 2 cohorts, one for deriving the model and the other to validate the model. MEASUREMENTS AND MAIN RESULTS: A total of 3441 patients were included. The rate of composite adverse outcomes was 14.1%. The final logistic regression risk-prediction model identified 6 variables predictive of an adverse outcome at the time of LH: race, history of laparotomy, history of laparoscopy, predicted preoperative uterine weight, body mass index, and surgeon annual case volume. Specifically included were race (97% increased odds of an adverse outcome for black women [95% confidence interval (CI), 34%-110%] and 34% increased odds of an adverse outcome for women of other races [95% CI, -11% to 104%] when compared with white women), history of laparotomy (69% increased odds of an adverse outcome [95% CI, 26%-128%]), history of laparoscopy (65% increased odds of an adverse outcome [95% CI, 21%-124%]), and predicted preoperative uterine weight (2.9% increased odds of an adverse outcome for each 100-g increase in predicted weight [95% CI, 2%-4%]). Body mass index and surgeon annual case volume also had a statistically significant nonlinear relationship with the risk of an adverse outcome. The c-statistic values for the derivation and validation cohorts were 0.74 and 0.72, respectively. The model is best calibrated for patients at lower risk (<20%). CONCLUSION: The LH risk-prediction model is a potentially powerful tool for predicting adverse outcomes in patients planning hysterectomy.

Reproductive Outcomes following Use of Barbed Suture during Laparoscopic Myomectomy.

STUDY OBJECTIVE: To review pregnancy outcomes after laparoscopic myomectomy with the use of barbed suture. DESIGN: Retrospective cohort study and follow-up survey. SETTING: Single, large academic medical center. PATIENTS: Patients who underwent laparoscopic myomectomy with the use of barbed suture for myometrial closure between 2008 and 2016. INTERVENTION: Laparoscopic myomectomy and a follow-up survey regarding pregnancy outcome. MEASUREMENTS AND MAIN RESULTS: A total of 486 patients met inclusion criteria and underwent a laparoscopic myomectomy between 2008 and 2016. Of the 428 with viable contact information, 240 agreed to participate (56%). Of those who responded to the survey, 101 (42%) attempted to get pregnant, and there were 4 unplanned pregnancies. There were 110 pregnancies among 76 survey respondents. In total, of the women attempting a postoperative pregnancy, 71% had at least 1 pregnancy. Comparing the women who did and did not conceive postoperatively, the group who got pregnant was on average younger, 33.8 ± 4.5 years vs 37.5 ± 6.5 years (p = .001); had fewer myomas removed, median = 2 (range 1-9) vs median = 2 (range 1-16) myomas (p = .038); and had a longer follow-up period, 30 months ( vs 30 (11-93 months) ± 20 (p <.001). The mean time to first postoperative pregnancy was 18.0 months (range 2-72 months). Of the 110 reported postoperative pregnancies, there were 60 live births (55%), 90% by means of cesarean section. The mean gestational age at birth was 37.8 weeks. In the cohort, there were 8 preterm births, 3 cases of abnormal placentation, 2 cases of fetal growth restriction, 3 cases of hypertensive disorders of pregnancy, and 2 cases of myoma degeneration requiring hospitalization for pain control. There were no uterine ruptures reported. CONCLUSION: According to our findings, pregnancy outcomes after laparoscopic myomectomy with barbed suture are comparable with available literature on pregnancy outcomes with conventional smooth suture.