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

NCT00930696 | Completed Phase 2

• 1 other identifier: trial_lavage_01/endometriosis
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Post-operative C-reactive protein blood values

  Daily for 1 week

Secondary Outcomes (1)

• Bowel complications rate

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

Study Arms (2)

Extensive Abdominal Lavage

EXPERIMENTAL

women with full thickness excision of deep endometriosis involving the bowel

Procedure: Extensive abdominal lavage

Standard Rinsing

ACTIVE COMPARATOR

women with full thickness excision of deep endometriosis involving the bowel

Procedure: Rinsing of the abdomen

Interventions

Extensive abdominal lavage PROCEDURE

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

Extensive Abdominal Lavage

Rinsing of the abdomen PROCEDURE

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

Standard Rinsing

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospital Gasthuisberg

Leuven, 3000, Belgium

Location

Related Publications (6)

• 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.

  PMID: 9333702 BACKGROUND

• 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.

  PMID: 1181805 BACKGROUND

• 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.

  PMID: 8943540 BACKGROUND

• 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.

  PMID: 16920418 BACKGROUND

• 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.

  PMID: 17218226 BACKGROUND

• 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.

  PMID: 16966207 BACKGROUND

MeSH Terms

Conditions

Endometriosis; Intestinal Perforation

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Philippe R Koninckx, MD, PhD

  Catholic University Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 26, 2009
• First Posted: June 30, 2009
• Study Start: May 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: June 30, 2009

Record last verified: 2009-06

Locations

BE (1)