Outcome After Multidisciplinary CO2 Laser Laparoscopic Excision of Deep Infiltrating Colorectal Endometriosis - Full Text View

Sponsored by:	University Hospital, Gasthuisberg
Information provided by:	University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:	NCT00461838

Purpose

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	Intervention
Endometriosis	Procedure: multidisciplinary laparoscopy Other: Questionnaires

MedlinePlus related topics: Endometriosis Infertility

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Outcome After Multidisciplinary CO2 Laser Laparoscopic Excision of Deep Infiltrating Colorectal Endometriosis

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Endometriosis was proven by histologic examination of excised lesions.

Enrollment:	56
Study Start Date:	September 1996
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Groups/Cohorts

Assigned Interventions

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.

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).

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	University Hospitals Leuven ( Christel Meuleman, MD )
Study ID Numbers:	ML2818 - 22/10/2004
Study First Received:	April 17, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00461838
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:

colorectal endometriosis
deep infiltrating endometriosis
dysmenorroe
dyspareunia
quality of life

Study placed in the following topic categories:

Genital Diseases, Female
Quality of Life
Endometriosis
Dyspareunia

ClinicalTrials.gov processed this record on February 12, 2009