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

NCT ID: NCT00930696

Last Updated: 2009-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2007-01-31

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.

Conditions

Endometriosis

Keywords

endometriosis; abdominal lavage; bowel perforation; discoid resection; laparoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Extensive Abdominal Lavage

women with full thickness excision of deep endometriosis involving the bowel

Group Type: EXPERIMENTAL

Extensive abdominal lavage

Intervention Type: PROCEDURE

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

Standard Rinsing

women with full thickness excision of deep endometriosis involving the bowel

Group Type: ACTIVE_COMPARATOR

Rinsing of the abdomen

Intervention Type: PROCEDURE

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

Interventions

Extensive abdominal lavage

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

Intervention Type: PROCEDURE

Rinsing of the abdomen

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

UZ Gasthuisberg, Catholic University Leuven

Principal Investigators

Philippe R Koninckx, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catholic University Leuven

Locations

University Hospital Gasthuisberg

Leuven, , Belgium

Countries

Belgium

References

Adam U, Ledwon D, Hopt UT. [Programmed lavage as a basic principle in therapy of diffuse peritonitis]. Langenbecks Arch Chir. 1997;382(4 Suppl 1):S18-21. doi: 10.1007/pl00014638. German.

Reference Type: BACKGROUND

PMID: 9333702 (View on PubMed)

Arnesjo B, Breland U, Petersson BG. The effect of peritoneal lavage on the postoperative course after colonic anastomosis and perforation in the rat. Acta Chir Scand. 1975;141(5):433-6.

Reference Type: BACKGROUND

PMID: 1181805 (View on PubMed)

Koninckx PR, Timmermans B, Meuleman C, Penninckx F. Complications of CO2-laser endoscopic excision of deep endometriosis. Hum Reprod. 1996 Oct;11(10):2263-8. doi: 10.1093/oxfordjournals.humrep.a019087.

Reference Type: BACKGROUND

PMID: 8943540 (View on PubMed)

Polubinska A, Winckiewicz M, Staniszewski R, Breborowicz A, Oreopoulos DG. Time to reconsider saline as the ideal rinsing solution during abdominal surgery. Am J Surg. 2006 Sep;192(3):281-5. doi: 10.1016/j.amjsurg.2005.05.047.

Reference Type: BACKGROUND

PMID: 16920418 (View on PubMed)

Ret Davalos ML, De Cicco C, D'Hoore A, De Decker B, Koninckx PR. Outcome after rectum or sigmoid resection: a review for gynecologists. J Minim Invasive Gynecol. 2007 Jan-Feb;14(1):33-8. doi: 10.1016/j.jmig.2006.07.015.

Reference Type: BACKGROUND

PMID: 17218226 (View on PubMed)

Sortini D, Feo CV, Maravegias K, Carcoforo P, Pozza E, Liboni A, Sortini A. Role of peritoneal lavage in adhesion formation and survival rate in rats: an experimental study. J Invest Surg. 2006 Sep-Oct;19(5):291-7. doi: 10.1080/08941930600889409.

Reference Type: BACKGROUND

PMID: 16966207 (View on PubMed)

Other Identifiers

trial_lavage_01/endometriosis

Identifier Type: -

Identifier Source: org_study_id