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Outcome After Multidisciplinary CO2 Laser Laparoscopic Excision of Deep Infiltrating Colorectal Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00461838
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : February 20, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Endometriosis Procedure: multidisciplinary laparoscopy Other: Questionnaires

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 Design

Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcome After Multidisciplinary CO2 Laser Laparoscopic Excision of Deep Infiltrating Colorectal Endometriosis
Study Start Date : September 1996
Primary Completion Date : July 2004
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.
Procedure: multidisciplinary laparoscopy
Multidisciplinary (with active involvement of the colorectal surgeon/urologist) fertility-sparing CO2 laser laparoscopic radical excision of deep infiltrating endometriosis.
Other: Questionnaires
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.


Outcome Measures

Primary Outcome Measures :
  1. 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) ]

Biospecimen Retention:   Samples Without DNA
Endometriosis was proven by histologic examination of excised lesions.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461838


Locations
Belgium
University Hospital Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
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
More Information

Responsible Party: Christel Meuleman, MD, University Hospitals Leuven
ClinicalTrials.gov Identifier: NCT00461838     History of Changes
Other Study ID Numbers: ML2818 - 22/10/2004
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009

Keywords provided by University Hospital, Gasthuisberg:
colorectal endometriosis
deep infiltrating endometriosis
dysmenorroe
dyspareunia
quality of life

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female