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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00461838
First received: April 17, 2007
Last updated: February 19, 2009
Last verified: February 2009
  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

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

Resource links provided by NLM:


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

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Christel Meuleman, MD, University Hospitals Leuven
ClinicalTrials.gov Identifier: NCT00461838     History of Changes
Other Study ID Numbers: ML2818 - 22/10/2004
Study First Received: April 17, 2007
Last Updated: February 19, 2009
Health Authority: Belgium: Institutional Review Board

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 24, 2014