Surgical Excision Versus Ablation for Superficial Endometriosis-Associated Pain: A Randomized Controlled Trial.

STUDY OBJECTIVE: To compare surgical excision and ablation of endometriosis for treatment of chronic pelvic pain. DESIGN: Randomized clinical trial with 12-month follow-up (Canadian Task Force classification I). SETTING: Single academic tertiary care hospital. PATIENTS: Women with minimal to mild endometriosis undergoing laparoscopy. INTERVENTIONS: Excision or ablation of superficial endometriosis at the time of robot-assisted laparoscopy. MEASUREMENTS AND MAIN RESULTS: Primary outcome was visual analog scale (VAS) scoring at baseline and 6 and 12 months for menstrual pain, nonmenstrual pain, dyspareunia, and dyschezia. Secondary outcomes included survey results at baseline and 6 and 12 months from the Short Form Health Survey, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire, and the International Pelvic Pain Assessment. From December 2013 to October 2014, 73 patients were randomized intraoperatively to excision (n = 37) or ablation (n = 36) of endometriosis. Patients were followed at 6 and 12 months to evaluate the above outcomes. After ablation of endometriosis, dyspareunia (VAS scores) improved at 6 months (mean change [MC], -14.07; 95% confidence interval [CI], -25.93 to -2.21; p = .02), but improvement was not maintained at 12 months. Dysmenorrhea improved at 6 months (MC, -26.99; 95% CI, -41.48 to -12.50; p < .001) and 12 months (MC, -24.15; 95% CI, 39.62 to -8.68; p = .003) with ablation. No significant changes were seen in VAS scores after excision at 6 or 12 months. When comparing ablation and excision, the only significant difference was a change in dyspareunia at 6 months (MC, -22.96; 95% CI, -39.06 to -6.86; p = .01). CONCLUSION: Treatment with ablation improved dysmenorrhea at 6 and 12 months and improved dyspareunia at 6 months as compared with preoperative data. However, only dyspareunia demonstrated a significant difference between ablation and excision. Excision and ablation showed similar effectiveness for the treatment of pain associated with superficial endometriosis, with ablation showing more significant individual changes. Careful patient counseling regarding expectations of surgical intervention is vital in the management of endometriosis.

Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy.

OBJECTIVE: To compare the operative time between robot-assisted laparoscopic hysterectomies and standard laparoscopic hysterectomies. METHODS: A prospective, randomized controlled trial enrolled women aged 18-80 years attending Penn State Hershey Medical Center between April 23 and October 20, 2014 to undergo hysterectomy. Participants were randomized using a random number generator to undergo either robot-assisted or standard laparoscopic hysterectomy. The primary outcome was the total operative time (surgeon incision to surgeon stop, including robot docking time, if applicable). Intention-to-treat analyses were performed and the operative time was compared between the two treatments for non-inferiority, defined as a difference in operative time of no longer than 15 minutes. RESULTS: There were 72 patients randomized to each treatment arm. The mean operative time was 73.9 minutes (median 67.0 minutes; interquartile range 59.0-83.0 minutes) in the robot-assisted hysterectomy group and 74.9 minutes (median 65.5 minutes; interquartile range 57.0-90.5 minutes) in the standard laparoscopic hysterectomy group. The upper bound of the 95% confidence interval of the difference in operative time was 6.6 minutes, below the 15-minute measure of non-inferiority. CONCLUSION: When performed by a surgeon experienced in both techniques, the operative time for robot-assisted laparoscopic hysterectomy was non-inferior to that achieved with standard laparoscopic hysterectomy. CLINICALTRIALS.GOV: NCT02118974.

Characteristics of patients undergoing hysterectomy for failed endometrial ablation.

BACKGROUND AND OBJECTIVES: Endometrial ablation is a minimally invasive procedure for menorrhagia. High success rates are documented with >90% of patients experiencing satisfaction. However, adequate relief after endometrial ablation is not obtained in a cohort of patients. The purpose of this study is to identify the characteristics of patients for whom endometrial ablation fails due to persistent symptoms, causing them to choose hysterectomy for definitive treatment. METHODS: We conducted a retrospective chart review of patients who underwent hysterectomy for persistent menorrhagia, pain, or both, who previously had endometrial ablation. We reviewed medical records including pathology reports from hysterectomy. We compared demographics to a group previously studied at our institution that were identified as satisfied 5 years after ablation. RESULTS: The number of patients in our study group was 51 (n = 51). Median age of patients was 39 (range 29-50) years. Average body mass index was 31 (range 19-47) kg/m(2). Average parity was 1.9. Sixty-nine percent underwent tubal ligation. The majority were nonsmokers (75%). Ninety-six percent were Caucasian. Compared with the previously studied satisfied group, the only statistically significant difference was age. Of 51 patients, 11 (22%) noted pelvic pain as their chief concern. Menorrhagia was the chief concern in 22 (43%). Eighteen patients (35%) complained of both. The most common diagnosis was endometriosis, which was identified in 35 patients (68%). Leiomyomata were present in 33 patients (64%). Adenomyosis was identified in 22 patients (43%). CONCLUSIONS: Patients who present for hysterectomy after endometrial ablation have a high rate of endometriosis, adenomyosis, and leiomyomata, with endometriosis being the most common finding.