Clinical trial NCT04109378: The Impact of NOSE-colectomy on Fertility and Quality of Life Among Patients With Colorectal Endometriosis
Official title: The Impact of NOSE-colectomy on Fertility and Quality of Life Among Patients With Colorectal Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Quality of Life
Keywords: Fertility
Colorectal endometriosis
Surgery
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our study was designed as a two-arm prospective randomized trial where all cases will be executed unblindly. As an experimental clinical trial the cases have been managed independently where the applied measures were computer based randomization.

In addition clustering effect has been examined within the two groups. The statistical power will be calculated for a sample size.

Randomization: Blinding in our study is not feasible.

Assignment of a patient to conventional or NOSE-colorectal resection is based on a randomization list using the simple randomization method. In order to determine the allocation sequence a computer based (www.random.org) coin flipping is carried out by a staff member with no clinical involvement in the study. The randomization will start after the patient had completed all baseline assessments and had given written consent to be enrolled in the trial.
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion criteria:

* Age: 18 - 45 years (both inclusive)
* Complaining of infertility and/or pain
* Deep endometriosis infiltrating the rectum on at least one imaging technique or confirmed by previous surgery

  * up to 15 cm from the anus
  * Involving at least the muscularis layer in depth

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Suspected pelvic malignancy
* Pregnancy
* Patients without bowel resection

Primary outcomes:
measure: Endometriosis Health Profile, EHP 30
timeFrame: 24 months
measure: Gastrointestinal Quality of Life Index, GIQLI
timeFrame: 24 months
measure: LARS score before and after colorectal resection for DIE
timeFrame: 24 months
measure: Endometriosis related pain before and after colorectal resection for DIE
timeFrame: 24 months
measure: Infertility outcomes after colorectal resection for bowel endometriosis
timeFrame: 24 months
measure: Psychological questionnaires:
timeFrame: 24 months
Secondary outcomes:
measure: Complication rates after conventional and NOSE-colectomy performed for colorectal endometriosis
timeFrame: 24 months
measure: Hospital stay after colorectal resection perfomed for the treatment of bowel endometriosis
timeFrame: 24 months
measure: Lenght of recovery after colorectal resection performed for the treatment of bowel endometriosis
timeFrame: 24 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University
Study officials:
affiliation: Semmelweis University
name: Attila Bokor, MD, PhD
role: STUDY_DIRECTOR
affiliation: Semmelweis University
name: Noemi Dobo, MD
role: STUDY_CHAIR
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