NCT04109378

The Impact of NOSE-colectomy on Fertility and Quality of Life Among Patients With Colorectal Endometriosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Deep infiltrating endometriosis (DIE) represents the most severe form of endometriosis and is present in 20-35% of all women suffering from the disease. Intestinal nodules are observed in 3% to 37% of endometriosis patients. In cases of colorectal DIE, adequate therapy depends on the depth of infiltration and the size of the lesion as well as the woman's quality of life. Removal of the specimen after segmental bowel resection can be performed by either mini-laparotomy or by the natural orifice specimen extraction (NOSE) technique . The assessment of the quality of life and fertility outcome of the patients was done by using electronic questionnaires before and after surgery.

Detailed description

Endometriosis is an enigmatic disease affecting 6-10% of women of reproductive age or 176 millions of women worldwide (1). Endometriosis is defined as the presence of endometrial-like tissue outside the uterus and it induces a chronic inflammatory reaction (2). Deep infiltrating endometriosis (DIE) represents the most severe form of endometriosis (described by the invasion of anatomical structures and organs deeper than 5 mm beyond the peritoneum) and is present in 20-35% of all women suffering from the disease (3). Intestinal deep infiltrating endometriosis is known as lesions infiltrating at least the muscular layer of the bowel wall and most commonly affects the rectum, sigmoid colon and the rectovaginal septum. (4). Even if bowel endometriosis may be totally asymptomatic, in many patients intestinal wall DIE alters significantly quality of life by provoking constipation, diarrhea, hematochezia, intestinal cramping, abdominal bloating, intestinal stenosis or obstruction and pain of defecation (5, 6). Rectal fixation to adjacent structures results in angulation of the rectum and subsequent defecatory pain and constipation. Fibrosis of nodules can lead to rectal constriction and stenosis, cyclical inflammation of the rectal wall may lead to changes in bowel habit (usually diarrhoea) with or without rectal bleeding (7). Although the surgical laparoscopic management of endometriosis is widely accepted, the optimal type of resection, whether conservative approach (shaving, disc resection) or radical technique (involves limited resection of the bowel wall with preservation of all adjacent structures-autonomic pelvic plexus, rectal vascular supply- known as "nerve-vessel sparing limited segmental resection"), is under discussion for treatment of deep endometriosis infiltrating the rectum. In cases of colorectal DIE, adequate therapy depends on the precise location, extent of the nodule and depth of invasion, as well as the woman's quality of life (3). Removal of the specimen after segmental bowel resection can be performed by either mini-laparotomy (conventional method) or by the natural orifice specimen extraction (NOSE) technique. (8). The conventional method raises concerns because this could disrupt the integrity of the abdominal wall. Moreover, extraction site laparotomy is associated with higher postoperative pain scores. The occurrence of particular complications such as incisional hernias and wound infections is also higher than after conventional laparoscopic procedures (8). In order to avoid these complications, NOSE technique has been introduced. During NOSE colectomy the specimen is extracted through a natural orifice and an intracorporeal anastomosis is performed (8). Several studies have demonstrated a significant drop in pain scores and amelioration of impaired sexual functioning and improved pregnancy rates in women following surgical resection of colorectal endometriosis (9). The aim of this study is to report the short, medium and long-term bowel functional outcomes and improvement of infertility, quality of life in women undergoing conventional and NOSE segmental bowel resection for endometriosis at our institution using validated questionnaires. Functional and psychological outcomes will be assessed using different questionnaires at baseline and postoperative follow-up moments. * Endometriosis Health Profile, EHP 30 (10) * Gastrointestinal Quality of Life Index, GIQLI (11) * Low Anterior Resection Syndrome score, LARS (12) * Assessment of endometriosis related pain: Visual Analog Scale (13) * Psychological questionnaires: Pain catastrophizing Scale (14), Self-Efficacy for Managing Chronic Disease 6-item Scale (15).

Conditions

• Endometriosis
• Quality of Life

Interventions

Type	Name	Description
PROCEDURE	Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE	For conventional laparoscopic and NOSE techniques a 4-port approach is used. The rectum is skeletonized. The distal rectum is closed using an endoscopic linear stapler. The mobilized rectum with the specimen is retrieved through a small suprapubic incision. The anvil of a conventional circular stapler is introduced in the proximal colon after placement of a purse string suture. A circular stapled colorectal anastomosis is fired. In case of NOSE, both the proximal sigmoid colon and the proximal rectum are tied off laparoscopically with a nonabsorbable suture. A transverse colotomy is performed in healthy tissue using a harmonic scalpel to deliver the anvil from a circular stapler introduced through the anus. The specimen is extracted transrectally in a specimen retrieval bag. Proximal part of the anastomosis is completed by suturing the anvil in place with a laparoscopic suture. The distal rectum is closed using a linear stapler. End-to-end anastomosis is made using the circular stapler

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-03-23
• Completion: 2021-03-23
• First posted: 2019-09-30
• Last updated: 2022-05-17

Locations

1 site across 1 country: Hungary