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

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ClinicalTrials.gov Identifier: NCT00930696
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : June 30, 2009
Sponsor:
Information provided by:
Katholieke Universiteit 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.

Condition or disease Intervention/treatment Phase
Endometriosis Procedure: Extensive abdominal lavage Procedure: Rinsing of the abdomen Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Post-operative C-reactive protein blood values [ Time Frame: Daily for 1 week ]

Secondary Outcome Measures :
  1. Bowel complications rate [ Time Frame: By the clinicians during the first post-operative week and at 1 and 6 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009

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