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

Extensive Abdominal Lavage Following Laparoscopic Full Thickness Resection of Deep Endometriosis Involving the Bowel, Effects on Post-Operative Inflammation: a Randomised Controlled Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00930696
Enrollment
20
Registered
2009-06-30
Start date
2005-05-31
Completion date
2007-01-31
Last updated
2009-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

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

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.

Interventions

PROCEDUREExtensive abdominal lavage

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

PROCEDURERinsing of the abdomen

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

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Post-operative C-reactive protein blood valuesDaily for 1 week

Secondary

MeasureTime frame
Bowel complications rateBy the clinicians during the first post-operative week and at 1 and 6 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026