Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis

Endometriosis Clinical Trial

Official title:

A Retrospective Follow-up of Patients After Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462176
• Other study ID #: ML2818 - 20/02/2006 a
• Status: Completed
• Phase: N/A
• First received: April 17, 2007
• Last updated: February 19, 2009
• Start date: September 2004
• Est. completion date: February 2008

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

This study is executed to evaluate the outcome on quality of life, pain, sexuality, pregnancy rate and recurrence rate after a fertility sparing multidisciplinary CO2 laser laparoscopic radical excision of deep infiltrating colorectal endometriosis with a bowel resection.

Description:

Patients

All women (n=45) who had undergone fertility sparing CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with bowel resection were selected retrospectively from the list of all patients (n=more than 500, of whom slightly more than 50% with endometriosis) operated at the Leuven University Fertility Centre (LUFc) between September 2004 and September 2006.

Questionnaires

All 45 patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire (27), a sexual activity questionnaire (28), visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, and to answer questions about medication and fertility, to compare their status before surgery and at the moment of the evaluation (December 2008).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 43 Years

Eligibility

Inclusion Criteria:

• Patients suffering from deep infiltrating endometriosis with colorectal extension

• Who had undergone CO2 laser laparoscopic radical excision of the endometriosis

• with bowel resection performed by the colorectal surgeon

• between September 2004 and July 2006.

Exclusion Criteria:

• Patients without bowel resection

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• multidisciplinary laparoscopy
Laparoscopic segmental bowel resection for deep infiltrating colorectal endometriosis performed by an experienced colorectal surgeon.

Other:
• Questionnaires
All 45 patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire, a sexual activity questionnaire, visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, and to answer questions about medication and fertility, to compare their status before surgery and at the moment of the evaluation (December 2008).

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	Pain; Sexuality; Quality of life; Fertility rate; Complication rate; Recurrence rate		a median follow-up of 27 months (range 16 - 40 months) after surgery	No
Secondary	Economic life circumstances		a median follow-up of 27 months (range 16 - 40 months) after surgery	No