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Completed

NCT Number: NCT00930696

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Gasthuisberg

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extensive abdominal lavage

Procedure

Extensive lavage of the abdomen with 8 liters of saline at the end of the surgical procedure

Rinsing of the abdomen

Procedure

Standard rinsing of the abdomen with some 0,5 liters of saline at the end of the surgical procedure

Primary outcomes

  1. Post-operative C-reactive protein blood values

    Time frame: Daily for 1 week

Secondary outcomes

  1. Bowel complications rate

    Time frame: By the clinicians during the first post-operative week and at 1 and 6 months

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 30, 2009
Registry last updated
Jun 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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