Clinical Trial: Effects of Extensive Abdominal Lavage on Postoperative Inflammation Following Full Thickness Excision of Deep Endometriosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

In a consecutive series 20 women with full thickness resection for deep endometriosis received randomly, at the end of the procedure, a standard abdominal rinsing (n=10) or extensive abdominal lavage with 8 Liters of saline (n=10). C-reactive protein and white blood cell count values were collected daily for 7 days. Women were observed for complications during the first post-operative week and during the follow up at 1 and 6 months.

The primary end point was to evaluate the effects of extensive abdominal lavage on post-operative inflammation. Secondary end-point was to explore the potential protective rule against post-operative bowel complications.

Sponsor: Katholieke Universiteit Leuven

Current Primary Outcome: Post-operative C-reactive protein blood values [ Time Frame: Daily for 1 week ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Bowel complications rate [ Time Frame: By the clinicians during the first post-operative week and at 1 and 6 months ]

Original Secondary Outcome: Same as current

Information By: Katholieke Universiteit Leuven

Dates:
Date Received: June 26, 2009
Date Started: May 2005
Date Completion:
Last Updated: June 29, 2009
Last Verified: June 2009