A Phase 2 interventional study of Extensive abdominal lavage and Rinsing of the abdomen in Endometriosis, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2009-06-30.
Sponsored by KU Leuven · Phase 2, Interventional, and Treatment
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.
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's enrollment of 20 is below the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.
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Exclusion Criteria:
women with full thickness excision of deep endometriosis involving the bowel
Procedure: Extensive abdominal lavage
women with full thickness excision of deep endometriosis involving the bowel
Procedure: Rinsing of the abdomen
Extensive lavage of the abdomen with 8 liters of saline at the end of the surgical procedure
Standard rinsing of the abdomen with some 0,5 liters of saline at the end of the surgical procedure
Post-operative C-reactive protein blood values
Time frame: Daily for 1 week
Bowel complications rate
Time frame: By the clinicians during the first post-operative week and at 1 and 6 months
This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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KU Leuven