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

Catholic University (KU) of Leuven

Status and phase

Completed

Phase 2

Conditions

Endometriosis

Treatments

Procedure: Rinsing of the abdomen

Procedure: Extensive abdominal lavage

Study type

Interventional

Funder types

Other

Identifiers

NCT00930696

trial_lavage_01/endometriosis

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No 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.