Clinical trial NCT00930696: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: endometriosis
abdominal lavage
bowel perforation
discoid resection
laparoscopy
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Post-operative C-reactive protein blood values
timeFrame: Daily for 1 week
Secondary outcomes:
measure: Bowel complications rate
timeFrame: By the clinicians during the first post-operative week and at 1 and 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
Study officials:
affiliation: Catholic University Leuven
name: Philippe R Koninckx, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.