Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis

Sponsor

University Hospital, Gasthuisberg (Other)

Overall Status

Completed

CT.gov ID

NCT00462176

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Procedure: multidisciplinary laparoscopy Other: Questionnaires

Detailed 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).

Study Design

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
1 All women (n=45) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of the colorectal surgeon performing a bowel resection were selected retrospectively from the list of all patients (n=more than 400) operated at the Leuven University Fertility Centre (LUFc) between September 2004 and July 2006.	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).

Arm

Intervention/Treatment

All women (n=45) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of the colorectal surgeon performing a bowel resection were selected retrospectively from the list of all patients (n=more than 400) operated at the Leuven University Fertility Centre (LUFc) between September 2004 and July 2006.

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).

Outcome Measures

Primary Outcome Measures

Pain; Sexuality; Quality of life; Fertility rate; Complication rate; Recurrence rate [a median follow-up of 27 months (range 16 - 40 months) after surgery]

Secondary Outcome Measures

Economic life circumstances [a median follow-up of 27 months (range 16 - 40 months) after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 43 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

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, Leuven, Belgium
Study Director: Thomas D'Hooghe, MD, PhD, University Hospital Gasthuisberg, Leuven, Belgium