Effects of Extensive Abdominal Lavage on Postoperative Inflammation Following Full Thickness Excision of Deep Endometriosis
- Conditions
- Endometriosis
- Interventions
- Procedure: Rinsing of the abdomenProcedure: Extensive abdominal lavage
- Registration Number
- NCT00930696
- Lead Sponsor
- KU Leuven
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
- The patients (aged 18-50 years) were all recruited from a single, tertiary referral hospital at Leuven University, Belgium, specializing in the surgical treatment of severe endometriosis.
- All the women were scheduled for a surgical excision of a rectovaginal nodule.
- Women with a full thickness involvement of the bowel requiring discoid resection were included.
- evidence on chest x-ray in the previous 3 months of old or currently active TB, even if adequately treated;
- evidence of serious infections (such as pneumonia or pyelonephritis) in the previous 3 months
- evidence of a documented HIV infection, active hepatitis-B or C, or an opportunistic infection (e.g. herpes zoster, cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) in the previous 6 months
- Previous transplant surgery, a lymphoproliferative disorder or other malignancy
- Positive cervical cytology in the previous 6 months
- Any haematological or biochemical abnormalities on routine screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Rinsing Rinsing of the abdomen women with full thickness excision of deep endometriosis involving the bowel Extensive Abdominal Lavage Extensive abdominal lavage women with full thickness excision of deep endometriosis involving the bowel
- Primary Outcome Measures
Name Time Method Post-operative C-reactive protein blood values Daily for 1 week
- Secondary Outcome Measures
Name Time Method Bowel complications rate By the clinicians during the first post-operative week and at 1 and 6 months
Trial Locations
- Locations (1)
University Hospital Gasthuisberg
🇧🇪Leuven, Belgium