Pressure-Induced Fibroid Ischemia: First-In-Human Experience with a Novel Device for Laparoscopic Treatment of Symptomatic Uterine Fibroids.

The purpose of this study was to assess the feasibility of use of a novel uterine fibroid treatment device hypothesized to cause fibroid infarction by increasing intra-tumoral pressure. Between August 2019 and January 2020, 21 uterine fibroids were treated in 16 symptomatic pre-menopausal black women. Pelvic magnetic resonance imaging was performed before the procedure, a day after the procedure and at 1, 3, 6, and 12 months. The subjects were also followed for clinical outcomes and quality of life up to 12 months at a single investigational site. At 3 months, the mean reduction in the fibroid volume was 36.3% (P = .002). Incremental reduction in volume peaked at the end of the follow-up, at the 12-month mark (60.4%; P = .008). There were no procedures in which the users failed to perform laparoscopic pressure suturing of fibroids with the pressure-induced fibroid ischemia device. Improvement in the quality of life was evident in the Health-Related Quality of Life total, Energy/Mood, Control, and Sexual Function domains of the Uterine Fibroid Symptom and Quality of Life questionnaire at 3 months post-procedure. Unanticipated risks were not identified. Serious adverse events were not identified. The initial clinical assessment of the pressure-induced fibroid ischemia device supports feasibility of the approach and does not reveal serious safety concerns. Trial is currently being registered retrospectively (This was a feasibility study and therefore registration was not mandatory).

Anterior Wall Success at 1 Year After Vaginal Uterosacral Ligament Suspension and Sacral Colpopexy.

OBJECTIVES: The primary objective was to evaluate 1-year anterior wall anatomic success rates for vaginal uterosacral ligament suspension (USLS) and minimally invasive sacral colpopexy (SCP) using delayed-absorbable suture. Secondary objectives included assessment of apical success, mesh or suture exposure, and postoperative quality of life (QoL) measures 12 months after surgery. METHODS: This was a retrospective cohort study including women who underwent a hysterectomy with concomitant USLS or SCP with delayed-absorbable suture from January 2011 to December 2015 with 1-year follow-up. Successful anterior vaginal wall support was defined as Ba of less than 0. Successful apical support was defined as no apical descent (point C) greater than one half of the total vaginal length. In addition, 1-year QoL questionnaires were measured postoperatively. RESULTS: A total of 282 women were identified. Sixty-two women (31 vaginal USLS and 31 SCP) met inclusion criteria. Demographics were similar between groups except for a higher body mass index in the USLS group (27.5 ± 5.6 kg/m vs 24.1 ± 3.3 kg/m, P < 0.05). Preoperative POP-Q was mostly stage II and III. At 1-year, anatomic success rates for the anterior compartment were 66.7% versus 90.3% for USLS and SCP groups, respectively (P = 0.02). There was no significant difference in apical success (P = 1.00) or QoL scores between groups at 1 year. CONCLUSIONS: Anatomic success rates at 1 year using delayed-absorbable suture were better for SCP when using the anterior wall as a measure of success, but there were no significant differences in apical success rates, mesh or suture exposure, and QoL measures between groups.

Objective structured assessment of technical skills for repair of fourth-degree perineal lacerations.

OBJECTIVE: The objective of this study was to assess the reliability and validity of an objective structured assessment of technical skills (OSATS) for repair of fourth-degree obstetric lacerations on a surgical model. STUDY DESIGN: Three blinded judges reviewed recordings of 20 junior and 20 senior obstetrics-gynecology residents performing simulated perineal repairs using a beef tongue model. Judges completed task-specific OSATS and global rating scales for each repair. Six recordings were rereviewed after 2 weeks. Inter- and intrarater reliability and construct validity were assessed. RESULTS: Interrater reliability was 0.80 for task-specific OSATS and 0.59 for the global rating scale. Intrarater reliability was poor. Construct validity was demonstrated, with senior residents scoring higher than junior residents on task-specific OSATS (13.0 vs 10.5; P = .007) and the global rating scale (24.0 vs 19.3; P = .001). CONCLUSION: We found good interrater reliability and construct validity using a task-specific OSATS for fourth-degree perineal laceration repair. This instrument shows promise as a tool for competency-based evaluations.

Persistent Vaginal Leakage in the Setting of an Apical Vaginal Sinus Tract: A Case Report.

Fistulas are defined as abnormal connections between 2 organ, vessels, or structures. They can often present in the genitourinary tract as a result of iatrogenic injury during pelvic surgery. A 46-year-old female presents many years after a hysterectomy for persistent vaginal leakage with concern for a vesicovaginal fistula. Computed tomography urogram, intravenous retrograde pyelogram, and cystoscopy were negative for vesicovaginal fistula; however, a vaginal sinus tract was noted and further explored. This case report will describe the use of both laparoscopy and concomitant vaginoscopy to diagnose and, ultimately, surgically excise a salpingovaginal fistula.

Textbook recommendations for preventing and treating perineal injury at vaginal delivery.

OBJECTIVE: To assess general obstetrics textbooks regarding the quality and quantity of information about perineal injury at vaginal delivery. METHODS: An obstetrics and gynecology resident, a perinatologist, and a urogynecologist evaluated 7 obstetrics textbooks by using a standardized abstraction form that delineated descriptions of anatomy and physiology, episiotomy use, and perineal trauma prevention and repair. RESULTS: Two textbooks briefly described anal sphincter anatomy, but none provided a detailed discussion of the relative contribution of anatomic components to continence. Four textbooks discussed the evidence for and against midline or mediolateral episiotomy, and 6 advised against routine episiotomy. Six textbooks described grading lacerations, but only one described detailed repair techniques for all grades. Two textbooks discussed techniques to reduce perineal trauma at the time of delivery. Only one textbook discussed the need to reapproximate the normal anal sphincter anatomy during perineal repair. CONCLUSION: Although most textbooks accurately reflect current literature regarding routine episiotomy, there is limited discussion of advantages and disadvantages of various types of episiotomy and little offered regarding prevention and repair of perineal trauma at delivery. LEVEL OF EVIDENCE: III.

Laparo-endoscopic single-site surgery hysterectomy using robotic lightweight endoscope assistants.

Current laparoscopic and robotic hysterectomy techniques require three to five small incisions in the abdominal wall. Each additional port contributes an additional risk for port site complications. Because of these risks, and in an effort to improve cosmesis, surgery through a single incision is being explored. New versatile robot devices can provide a less cumbersome and less expensive alternative to the conventional multi-arm robot devices. In the case reported here, that of a 37-year-old female undergoing hysterectomy, we combined the use of these two technologies in a novel way. By utilizing a single laparoscopic port site in addition to two lightweight robotic endoscope assistants, we were able to decrease risk and improve cosmesis while allowing single-operator control of all instrumentation. The novel use of this robotic device demonstrates a potential decrease in the need for surgical assistants and thus a decrease in cost. When combined with single-site laparoscopy, it also allows the surgeon complete control of the operative environment and may enable more surgeons to embrace the single-incision technique.

Laparoscopic management of ureteric obstruction after uterosacral vaginal vault suspension.

The uterosacral ligaments commonly are used to correct pelvic organ prolapse. For experienced surgeons, the rate of ureteral injury with uterosacral vaginal vault suspensions is 2%-4%. Exploratory laparotomy and ureterolysis has been used to treat iatrogenic ureteral injury. A 64-year-old woman with stage III pelvic organ prolapse underwent surgical correction with an uterosacral vaginal vault suspension. On postoperative day 1, the patient was diagnosed with partial ureteral obstruction. She underwent laparoscopic ureterolysis and stent placement. A follow-up intravenous pyelogram showed no evidence of damage or obstruction. With proper patient selection, ureteral obstruction after vault suspension procedures can be managed with laparoscopic ureterolysis, avoiding the morbidity associated with laparotomy.

Incidence of perioperative complications of urogynecologic surgery in elderly women.

OBJECTIVE: The purpose of this study was to determine the incidence of and risk factors for perioperative complications in elderly women who undergo urogynecologic surgery. STUDY DESIGN: A retrospective chart review of patients > or = 75 years old who underwent urogynecologic surgery between January 1999 and December 2003 was performed. Demographics, comorbidities, and significant perioperative complications were recorded. The Charlson Comorbidity Index and American Society of Anesthesiologists classification were calculated to summarize the patients' overall perioperative risk. Logistic regression was used to identify independent risk factors for perioperative complications. RESULTS: Two hundred sixty-seven patients who were > or = 75 years old met the inclusion criteria; 25.8% of the patients had a significant perioperative complication. The most common perioperative complication was blood transfusion or significant blood loss, pulmonary edema, and postoperative congestive heart failure. Independent risk factors that were predictive of a patient having a perioperative complication were the length of surgery, coronary artery disease, and peripheral vascular disease. The Charlson Comorbidity Index and American Society of Anesthesiologists classification did not predict perioperative complications in this population. CONCLUSION: Pre-existing cardiovascular disease increases the risk of a significant perioperative complication in elderly women who undergo urogynecologic surgery. However, the overall perioperative morbidity rate in elderly women who undergo urogynecologic surgery is low.

Adoption of the pelvic organ prolapse quantification system in peer-reviewed literature.

OBJECTIVE: The purpose of this study was to examine the method of describing pelvic organ prolapse in the peer-reviewed literature since the introduction of the Pelvic Organ Prolapse Quantification System (POPQ). STUDY DESIGN: Representative US and international gynecology and urology journals were selected for review. All prolapse or urinary incontinence articles published in these journals from January to December of 1999 (period 1) and July 2001 to June 2002 (period 2) were hand searched by two independent reviewers. Systems for grading the severity of pelvic organ prolapse were separated into the following categories: POPQ, Baden-Walker system, Beecham system, grade without reference, or nonstandardized system. Chi-square and Fisher exact tests were used for statistical analysis. RESULTS: A prolapse staging system was not referenced, or a nonstandardized staging system was used in 54.8% of studies. Overall, the POPQ system was the most common system used (22.6%), followed by the Baden-Walker system (19.8%). There was a statistically significant increase in the use of POPQ from period 1 (13.3%) to period 2 (28%) (P=.03). Articles published in gynecology journals were more likely to use the POPQ system than those published in urology journals (29% vs. 14%, P=.009). CONCLUSION: POPQ was the most common system used; however, the staging system was not cited or a nonstandardized staging system was used in more than half of studies.

Laparoscopy for adnexal masses in the second trimester of pregnancy.

STUDY OBJECTIVE: To assess the safety of laparoscopic treatment of adnexal masses in the second trimester of pregnancy. DESIGN: Retrospective chart review (Canadian Task Force classification II-3. SETTING: Large tertiary care medical center. PATIENTS: Eleven women. INTERVENTION: Laparoscopic surgery. MEASUREMENTS AND MAIN RESULTS: All masses were identified by ultrasound. The average gestational age at the time of surgery was 17 weeks, 4 days. In seven women the primary cannula was inserted in the left upper quadrant of the abdomen. Procedures were eight ovarian cystectomies, two oophorectomies, and one exploratory laparoscopy. Average operating time was 135 minutes (range 95-195 min). Average time exposed to carbon dioxide was 78 minutes (range 59-135 min). None of the masses was malignant. There were no fetal complications or malformations. No patients had preterm labor and all delivered at term. CONCLUSIONS: The increasing number of reported cases and our experience suggest that laparoscopic treatment of adnexal masses in the second trimester is safe and effective, but the surgeon must be skilled in advanced techniques of laparoscopic surgery.