Text Size

Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00462176
First received: April 17, 2007
Last updated: February 19, 2009
Last verified: February 2009
History of Changes
  Purpose

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 Intervention
Endometriosis
 Procedure: multidisciplinary laparoscopy
Other: Questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Follow-up of Patients After Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Pain; Sexuality; Quality of life; Fertility rate; Complication rate; Recurrence rate [ Time Frame: a median follow-up of 27 months (range 16 - 40 months) after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Economic life circumstances [ Time Frame: a median follow-up of 27 months (range 16 - 40 months) after surgery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

The diagnosis of endometriosis was confirmed by histologic examination of resected lesions.


Enrollment: 45
Study Start Date: September 2004
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

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).

  Eligibility

Ages Eligible for Study:   19 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462176

Locations
Belgium
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
  More Information

No publications provided

Responsible Party: Christel Meuleman, MD, University Hospitals Leuven, Leuven, Belgium
ClinicalTrials.gov Identifier: NCT00462176     History of Changes
Other Study ID Numbers: ML2818 - 20/02/2006 a
Study First Received: April 17, 2007
Last Updated: February 19, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:
colorectal endometriosis
deep infiltrating endometriosis
dysmenorroe
dyspareunia
quality of life

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013