Outcome After Multidisciplinary CO2 Laser Laparoscopic Excision of Deep Infiltrating Colorectal Endometriosis
February 19, 2009 updated by: University Hospital, Gasthuisberg
Improved pain, sexuality and quality of life, high fertility and low complication and recurrence rates after multidisciplinary CO2 laser laparoscopic excision of deep infiltrating colorectal endometriosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist were selected retrospectively from the list of all patients (n=more than 2000) operated at the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004.
All 56 multidisciplinary operated patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire, a sexual activity questionnaire and visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, to compare their status before surgery and at the moment of the evaluation (January 2005).
Study Type
Observational
Enrollment (Actual)
56
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leuven, Belgium, 3000
- University Hospital Gasthuisberg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist were selected retrospectively from the list of all patients (n=more than 2000) operated at the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004.
Description
Inclusion Criteria:
- All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist
- operated at the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004
Exclusion Criteria:
- Women who had undergone CO2 laser laparoscopic excision of deep infiltrating endometriosis without active involvement of colorectal surgeon and/or urologist
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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1
All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist were selected retrospectively from the list of all patients (n=more than 2000) operated at the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004.
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Multidisciplinary (with active involvement of the colorectal surgeon/urologist) fertility-sparing CO2 laser laparoscopic radical excision of deep infiltrating endometriosis.
Patients (n=56) were asked to complete questionnaires regarding quality of life (QOL), pain, fertility and sexuality to compare their status before and after surgery, and their medical files were analyzed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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complication rate, cumulative recurrence and cumulative fertility rate, pain, quality of life and sexual satisfaction
Time Frame: median follow-up: 29 months (range 6 - 76 months)
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median follow-up: 29 months (range 6 - 76 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christel LC Meuleman, MD, University Hospital Gasthuisberg, Catholic University, Leuven, Belgium
- Study Director: Thomas D'Hooghe, MD, PhD, University Hospital Gasthuisberg, Catholic University, Leuven, Belgium
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1996
Primary Completion (Actual)
July 1, 2004
Study Completion (Actual)
July 1, 2004
Study Registration Dates
First Submitted
April 17, 2007
First Submitted That Met QC Criteria
April 17, 2007
First Posted (Estimate)
April 18, 2007
Study Record Updates
Last Update Posted (Estimate)
February 20, 2009
Last Update Submitted That Met QC Criteria
February 19, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML2818 - 22/10/2004
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.