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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930696
• Other study ID #: trial_lavage_01/endometriosis
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2009
• Last updated: June 29, 2009
• Start date: May 2005
• Est. completion date: January 2007

Study information

• Verified date: June 2009
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• Extensive abdominal lavage
Extensive lavage of the abdomen with 8 liters of saline at the end of the surgical procedure
• Rinsing of the abdomen
Standard rinsing of the abdomen with some 0,5 liters of saline at the end of the surgical procedure

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

References & 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. German. — View Citation

Arnesjö 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. — View 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. — View 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. — View Citation

Ret Dávalos 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative C-reactive protein blood values		Daily for 1 week	No
Secondary	Bowel complications rate		By the clinicians during the first post-operative week and at 1 and 6 months	No