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

May 10, 2022 updated by: Semmelweis University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients operated with conventional laparoscopic technique
Patients operated with conventional laparoscopic technique for colorectal DIE
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
Active Comparator: Patients operated with NOSE laparoscopic technique
Patients operated with NOSE technique for colorectal DIE
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometriosis Health Profile, EHP 30
Time Frame: 24 months

To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum.

The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months.

Impact of surgical technique on the quality of life. The outcome will be assessed using validated electronic questionnaires containing questions from Endometriosis Health Profile 30. This is a core questionnaire which consists of five scales (pain, control and powerlessness, emotional well-being, social support, and self-image) contains a total of 30 items. (10)
24 months
Gastrointestinal Quality of Life Index, GIQLI
Time Frame: 24 months

To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum.

The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months.

GIQLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice of patients with gastrointestinal disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and subscores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life. (11)
24 months
LARS score before and after colorectal resection for DIE
Time Frame: 24 months

To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum.

The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months.

The Low Anterior Resection Syndrome (LARS) is a common complication that occures after colorectal surgery. The LARS score is a simple self-administered questionnaire measuring bowel dysfunction after rectal surgery. Contains questions regarding incontinence, emptying difficulties, urgency, and frequency. The calculated score ranges from 0 to 42, with a score of 0-20 representing no LARS, a score of 21-29 representing minor LARS and a score of 30-42 representing major LARS. (12)
24 months
Endometriosis related pain before and after colorectal resection for DIE
Time Frame: 24 months

To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum.

The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months.

For the assessment of pre- and postoperative pain a Visual Analogue Scale is used (from 1-10, where 1 is the lowest and 10 is the maximum score) to assess the pre- and postoperative quality of life (dysmenorrhoea, dyspareunia, dyschezia, dysuria, CPP) (13).
24 months
Infertility outcomes after colorectal resection for bowel endometriosis
Time Frame: 24 months
Number of pregnancies, cumulative pregnancy rate and take home baby rate after laparoscopic bowel resection.
24 months
Psychological questionnaires:
Time Frame: 24 months

To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum.

The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months.

Pain catastrophizing Scale, Self-Efficacy for Managing Chronic Disease 6-item Scale to investigate the psychological aspect of the disease (14,15).
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rates after conventional and NOSE-colectomy performed for colorectal endometriosis
Time Frame: 24 months

To measure the complication rates after conventional and NOSE-colectomy performed for colorectal endometriosis. The complication rates between the NOSE vs conventional specimen extraction technique will be examined. The difference between the complication rates will be presented according to Clavien-Dindo Classification System (16).

As follows:

Grade I Any deviation from the normal postoperative course without treatment by invasive interventions Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

Grade III

Requiring surgical, endoscopic or radiological intervention

  • IIIa

Intervention not under general anesthesia

  • IIIb

Intervention under general anesthesia Grade IV

Life-threatening complication requiring IC/ICU-management

  • IVa

single organ dysfunction (including dialysis)

  • IVb

multiorgan dysfunction Grade V Death of a patient
24 months
Hospital stay after colorectal resection perfomed for the treatment of bowel endometriosis
Time Frame: 24 months
To measure the hospital stay after colorectal resection perfomed for the treatment of bowel endometriosis
24 months
Lenght of recovery after colorectal resection performed for the treatment of bowel endometriosis
Time Frame: 24 months
To measure the lenght of recovery after bowel resection will be assessed by the comparison of the hospital stay (mean +/- SD days)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Investigators

  • Study Director: Attila Bokor, MD, PhD, Semmelweis University
  • Study Chair: Noemi Dobo, MD, Semmelweis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

March 23, 2021

Study Completion (Actual)

March 23, 2021

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SemmlweisU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Will individual participant data will be available (including datadictionaires)? Individual participant data will be available. What data in particular will be shared? Individual participant data that underline the results reported in the article after deidentification (text, tables, figures and appendices) will be shared.

What other documents will be available? Study protocol, statistical analysis plan, analytic code will be available as well.

When will data be available (start and end dates)? Data will be available from 3 months to 5 years after the publication of the article.

With whom? The data will be shared with researchers who provide a methodologically sound proposal.

For what types of analysis? To achieve aims in the approved proposal. By what mechanism will data be made available? Proposals should be directed to attila.z.bokor@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.

IPD Sharing Time Frame

5 years after study closure

IPD Sharing Access Criteria

Any researcher intersted in the study

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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