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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometriosis

Intervention / Treatment
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* Procedure: Extensive abdominal lavage
* Procedure: Rinsing of the abdomen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extensive Abdominal Lavage<br>women with full thickness excision of deep endometriosis involving the bowel | Procedure: Extensive abdominal lavage<br>* Extensive lavage of the abdomen with 8 liters of saline at the end of the surgical procedure<br>|
| Active Comparator: Standard Rinsing<br>women with full thickness excision of deep endometriosis involving the bowel | Procedure: Rinsing of the abdomen<br>* Standard rinsing of the abdomen with some 0,5 liters of saline at the end of the surgical procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative C-reactive protein blood values |  | Daily for 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel complications rate |  | By the clinicians during the first post-operative week and at 1 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, abdominal lavage, bowel perforation, discoid resection, laparoscopy