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

This study has been completed.
Sponsor:
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00930696
First received: June 26, 2009
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Endometriosis
Procedure: Extensive abdominal lavage
Procedure: Rinsing of the abdomen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Post-operative C-reactive protein blood values [ Time Frame: Daily for 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bowel complications rate [ Time Frame: By the clinicians during the first post-operative week and at 1 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: May 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extensive Abdominal Lavage
women with full thickness excision of deep endometriosis involving the bowel
Procedure: Extensive abdominal lavage
Extensive lavage of the abdomen with 8 liters of saline at the end of the surgical procedure
Active Comparator: Standard Rinsing
women with full thickness excision of deep endometriosis involving the bowel
Procedure: Rinsing of the abdomen
Standard rinsing of the abdomen with some 0,5 liters of saline at the end of the surgical procedure

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00930696

Locations
Belgium
University Hospital Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Philippe R Koninckx, MD, PhD Catholic University Leuven
  More Information

Publications:
Responsible Party: Koninckx Philippe, UZ Gasthuisberg, Catholic University Leuven
ClinicalTrials.gov Identifier: NCT00930696     History of Changes
Other Study ID Numbers: trial_lavage_01/endometriosis
Study First Received: June 26, 2009
Last Updated: June 29, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Katholieke Universiteit Leuven:
endometriosis
abdominal lavage
bowel perforation
discoid resection
laparoscopy

Additional relevant MeSH terms:
Inflammation
Endometriosis
Pathologic Processes
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 16, 2014