Effects of Extensive Abdominal Lavage on Postoperative Inflammation Following Full Thickness Excision of Deep Endometriosis
NCT00930696 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2009-06-30
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.
Conditions
- Endometriosis
Interventions
- PROCEDURE
-
Extensive abdominal lavage
Extensive lavage of the abdomen with 8 liters of saline at the end of the surgical procedure
- PROCEDURE
-
Rinsing of the abdomen
Standard rinsing of the abdomen with some 0,5 liters of saline at the end of the surgical procedure
Sponsors & Collaborators
-
KU Leuven
lead OTHER
Principal Investigators
-
Philippe R Koninckx, MD, PhD · Catholic University Leuven
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-05-31
- Primary Completion
- 2007-01-31
- Completion
- 2007-01-31
Countries
- Belgium
Study Locations
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