Long term outcomes of surgical management of rectal endometriosis: 10-year follow-up of patients enrolled in a randomized trial

OBJECTIVE: Data on long-term outcomes of surgical management of rectal endometriosis are scarce and generally provided by cohort studies where choice of surgical technique is based on various uncontrolled factors with significant lost-to-follow up patient rates. Based on the cohort of women enrolled in the ENDORE randomized trial, closely followed up over 10 years, we aimed to assess the long-term outcomes of surgical management of rectal endometriosis by nodule excision or segmental resection. STUDY DESIGN: Ten-year follow-up of a randomized controlled trial cohort enrolled in one center from May 2011 to October 2013 at Rouen University Hospital. 55 patients were managed for deep endometriosis infiltrating the rectum up to 15 cm from the anus, with more than a 20 mm-diameter area over the muscular layer and maximum 50% of rectal circumference. Patients randomly received either nodule excision (shaving or disc excision) or segmental colorectal resection. The primary endpoint of both the randomized trial and the present study was the number of patients experiencing at least one of the following symptoms: constipation (1 stool/>5 consecutive days), defecation pain, frequent bowel movements (>= 3 stools/day), anal incontinence, bladder dysfunction (at least one of the last three questions of the Urinary Symptom Profile score >=1). Secondary endpoints were values taken from the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS), Gastrointestinal Quality of Life Index (GIQLI), Wexner scale, Urinary Symptom Profile (USP), pregnancy rate, recurrences and reoperation rates. RESULTS: Fifty-five patients were enrolled, and 5 patients stopped follow-up prior to 10 years (9.1%). The primary endpoint was present in respectively 74.1% vs. 71.4% of patients (OR 0.88, 95% CI 0.27-2.9, P=0.83), while 59.1% vs. 58.3% of patients subjectively reported normal bowel movements (OR 0.97, 95%CI 0.30-3.1, P=0.96). An intention-to-treat comparison of overall KESS, GIQLI, Wexner, USP and SF36 scores did not reveal significant differences between the two arms 10 years postoperatively. Longitudinal Generalized Estimating Equations analysis revealed no differences between functional outcome trajectories over time for conservative and radical rectal surgery. The 10-year recurrence rates of rectal endometriosis in the excision vs. the segmental resection arms were 7.4 % vs. 3.6% (OR 0.46, 95%CI 0.04-5.4, P=0.54). Among patients with pregnancy intention after surgery, the pregnancy rate was 85.3%, with most conceiving naturally (64.4%). 45 children were born to 27 women. Second surgeries related to endometriosis were recorded in 32.7% of cases, with no difference between groups. CONCLUSION: Ten-year follow-up data show no statistically significant differences between conservative and radical rectal surgery for long-term functional digestive outcomes, rectal recurrence rate and risk of reoperation in this population of women with large involvement of the rectum. Most patients considered their bowel movements normal. Our study suggests that in patients undergoing surgical management of severe deep endometriosis of the rectum, the surgery-related benefits persist over 10 years postoperatively, with a low risk of rectal recurrence.