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

• Sponsor: University Hospital, Gasthuisberg (Other)
• Overall Status: Completed
• CT.gov ID: NCT00461838
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Duration (Months): 94
• Patients Per Site Per Month: 0.6

Study Details

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	Phase
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: Sep 1, 1996
• Actual Primary Completion Date: Jul 1, 2004
• Actual Study Completion Date: Jul 1, 2004

Arms and Interventions

Arm

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 [median follow-up: 29 months (range 6 - 76 months)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00461838
• Other Study ID Numbers: ML2818 - 22/10/2004
• First Posted: Apr 18, 2007
• Last Update Posted: Feb 20, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: colorectal endometriosis; deep infiltrating endometriosis; dysmenorroe; dyspareunia; quality of life
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Feb 20, 2009