Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis

NCT ID: NCT00462176

Last Updated: 2009-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

multidisciplinary laparoscopy

Intervention Type PROCEDURE

Laparoscopic segmental bowel resection for deep infiltrating colorectal endometriosis performed by an experienced colorectal surgeon.

Questionnaires

Intervention Type OTHER

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).

Interventions

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multidisciplinary laparoscopy

Laparoscopic segmental bowel resection for deep infiltrating colorectal endometriosis performed by an experienced colorectal surgeon.

Intervention Type PROCEDURE

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gasthuisberg

OTHER

Sponsor Role lead

Responsible Party

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University Hospitals Leuven, Leuven, Belgium

Principal Investigators

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Christel LC Meuleman, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Gasthuisberg, Leuven, Belgium

Thomas D'Hooghe, MD, PhD

Role: STUDY_DIRECTOR

University Hospital Gasthuisberg, Leuven, Belgium

Locations

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University Hospital Gasthuisberg

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ML2818 - 20/02/2006 a

Identifier Type: -

Identifier Source: org_study_id

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