CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Extensive abdominal lavage +1 moreprocedure
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/NCT00930696
NCT00930696Phase 2Completed

Extensive Abdominal Lavage Following Laparoscopic Full Thickness Resection of Deep Endometriosis Involving the Bowel, Effects on Post-Operative Inflammation: a Randomised Controlled Trial

KU Leuven·interventional·Posted Jun 30, 2009·Updated Jun 30, 2009

In Brief

A Phase 2 clinical trial evaluating Extensive abdominal lavage and Rinsing of the abdomen for Endometriosis. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Surgical treatment of deep endometriosis with bowel involvement is widely accepted to require complete excision of all endometriosis also when invading the bowel. In case of opening of the bowel a subsequent inflammatory reaction follows the surgery, as demonstrated by the increase in blood levels of C-reactive protein during the first post-operative week. Furthermore it increases the risk of post-operative bowel complications. In case of peritonitis the general surgeons use extensive lavage in order to decreases mortality, morbidity and post-operative adhesions formation, as demonstrated in animal models and clinically in patients with peritonitis. Considering the efficacy of extensive lavage for peritonitis and the inflammatory reaction as judged by the increased C-reactive protein (CRP) following full thickness deep endometriosis resection from the bowel, the study aims to evaluate, in women undergoing this procedure, the effect of extensive abdominal lavage on abdominal inflammation and post-operative bowel complications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometriosis
CountriesBelgium
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 30, 2009
Enrollment StartMay 1, 2005
Primary CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.0 years ago

Interventions

Extensive abdominal lavageprocedure

Extensive lavage of the abdomen with 8 liters of saline at the end of the surgical procedure

Rinsing of the abdomenprocedure

Standard rinsing of the abdomen with some 0,5 liters of saline at the end of the surgical procedure