- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00930696
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Leuven, Belgium, 3000
- University Hospital Gasthuisberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Extensive Abdominal Lavage
women with full thickness excision of deep endometriosis involving the bowel
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Extensive lavage of the abdomen with 8 liters of saline at the end of the surgical procedure
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Active Comparator: Standard Rinsing
women with full thickness excision of deep endometriosis involving the bowel
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Standard rinsing of the abdomen with some 0,5 liters of saline at the end of the surgical procedure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Post-operative C-reactive protein blood values
Time Frame: Daily for 1 week
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Daily for 1 week
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bowel complications rate
Time Frame: By the clinicians during the first post-operative week and at 1 and 6 months
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By the clinicians during the first post-operative week and at 1 and 6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- trial_lavage_01/endometriosis
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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