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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461838
• Other study ID #: ML2818 - 22/10/2004
• Status: Completed
• Phase: N/A
• First received: April 17, 2007
• Last updated: February 19, 2009
• Start date: September 1996
• Est. completion date: July 2004

Study information

• Verified date: February 2009
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complication rate, cumulative recurrence and cumulative fertility rate, pain, quality of life and sexual satisfaction		median follow-up: 29 months (range 6 - 76 months)	No