O-308 The impact of NOSE colectomy and laparoscopic conventional segmental resection on bowel function and quality of life among patients with rectal endometriosis: prospective randomized trial

Abstract

Abstract Study question What is the impact of laparoscopic conventional or NOSE colorectal resection on bowel function in patients with deep endometriosis infiltrating the rectum one year postoperatively? Summary answer Both conventional and NOSE colectomy improved the functional outcomes and quality of life among patients with deeply invasive rectal endometriosis one year after bowel surgery. What is known already Conventional laparoscopic approach to the surgical management of deep endometriosis infiltrating the rectum appears to assure improved digestive functional outcomes. NOSE technique for colorectal disease can significantly reduce the duration of hospital stay, accelerate postoperative recovery with better cosmetic results, and in particular, result in less postoperative pain and fewer complications. However, long-term solid data about gastrointestinal well-being after segmental bowel or NOSE resection for deep endometriosis are still missing. Study design, size, duration Between the 1st September 2019 - 31th of December 2020 we performed a 2-arm unblinded prospective randomized trial, enroling 91 patients with deep infiltrating rectal endometriosis up to 15 cm from the anal verge. Patients aged between 18 and 45 years, with deep endometriosis infiltrating at least the muscular layer in depth, and up to 50% of rectal circumference, complaining pain, bowel symptoms and/or infertility were included. The average follow up time was 14±2.6 months. Participants/materials, setting, methods Patients were enroled at Semmelweis University, Department of Obstetrics and Gynecology, Budapest, Hungary and had either conventional laparoscopic bowel resection or NOSE resection. Randomization was performed preoperatively using the simple randomization method. The primary endpoint was to assess the bowel function and quality of life by using the Endometriosis Health Profile 30, the Gastrointestinal Quality of Life Index and the Low Anterior Resection Syndrome score preoperatively, 1 month, 6 months, 1 year after the surgery. Main results and the role of chance A total of 91 patients were enroled. 39 patients were in the NOSE surgery arm, 49 were in the Conventional laparoscopic surgery arm. One patient was lost to follow-up and we had two cases of drop out from the trial after randomization due to performing non intended disc resection. This cases were excluded from the study. There was no conversion to laparotomy.The overall scores on Gastrointestinal Quality of Life Index (GIQLI), Low Anterior Resection Syndrome scores (LARS) and Endometriosis Health Profile 30 (EHP30) scores did not reveal significant differences between the two groups. LARS scores were improved, but did not reveal significant differences 12 months (T3) after the operation compared with the preoperative (T0) values in both groups (Conventional surgery group: T0=21.41 T3= 17.90; p = 0.934, NOSE surgery goup T0= 26.53 T3= 18.23; p = 0.229). GIQLI scores were significantly improved 12 months after the operation compared with the baseline values in Conventional surgery group T0= 95.44 T3= 111.39 p = 0.002. EHP30 scores were significantly improved concerning pain, emotion well-being, control and powerlessness, self-image, social support and sexuality scale 12 months after the operation compared with the preoperative values in both groups. Limitations, reasons for caution An obvious bias of performance is the lack of blinding, however blinding was not feasible due to the clinical nature of our study. We report no imprecision in patient selection, but a potential source of attrition bias in our data occured in a total number of three cases in NOSE-group. Wider implications of the findings Our study does not show a statistically significant difference between conventional or NOSE surgery for short and mid-term functional digestive outcomes. Occurrence of longterm bowel dysfunction does not appear to be related to a specific surgical technique. Trial registration number ClinicalTrials.gov number: NCT04109378