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

Primary Purpose

Endometriosis

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Extensive abdominal lavage

Rinsing of the abdomen

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring endometriosis, abdominal lavage, bowel perforation, discoid resection, laparoscopy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital Gasthuisberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extensive Abdominal Lavage

Standard Rinsing

Arm Description

women with full thickness excision of deep endometriosis involving the bowel

Outcomes

Primary Outcome Measures

Post-operative C-reactive protein blood values

Secondary Outcome Measures

Bowel complications rate

Full Information

NCT ID

NCT00930696

First Posted

June 26, 2009

Last Updated

June 29, 2009

Sponsor

KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT00930696

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

KU Leuven

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Extensive Abdominal Lavage

Arm Type

Experimental

Arm Description

women with full thickness excision of deep endometriosis involving the bowel

Arm Title

Standard Rinsing

Arm Type

Active Comparator

Arm Description

women with full thickness excision of deep endometriosis involving the bowel

Intervention Type

Procedure

Intervention Name(s)

Extensive abdominal lavage

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Rinsing of the abdomen

Intervention Description

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

Primary Outcome Measure Information:

Title

Post-operative C-reactive protein blood values

Time Frame

Daily for 1 week

Secondary Outcome Measure Information:

Title

Bowel complications rate

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe R Koninckx, MD, PhD

Organizational Affiliation

Catholic University Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Gasthuisberg

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

9333702

Citation

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.

Results Reference

background

PubMed Identifier

1181805

Citation

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.

Results Reference

background

PubMed Identifier

8943540

Citation

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.

Results Reference

background

PubMed Identifier

16920418

Citation

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.

Results Reference

background

PubMed Identifier

17218226

Citation

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.

Results Reference

background

PubMed Identifier

16966207

Citation

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.

Results Reference

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

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