CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIEprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04109378
NCT04109378N/ACompleted

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

Semmelweis University·interventional·Posted Sep 30, 2019·Updated May 17, 2022

In Brief

A clinical study evaluating Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE for Endometriosis and Quality of Life. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHungary
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 30, 2019
Enrollment StartSep 1, 2019
Primary CompletionMar 23, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.8 years ago

Interventions

Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIEprocedure

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