The Impact of NOSE-colectomy on Fertility and Quality of Life Among Patients With Colorectal Endometriosis
Condition: Endometriosis; Quality of Life
MeSH terms: Endometriosis
Study type: Interventional

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).
    

Intervention name(s): Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE
Intervention type(s): Procedure
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fertility; Colorectal endometriosis; Surgery