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

April 17, 2007
February 19, 2009
September 2004
February 2008   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00462176 on ClinicalTrials.gov Archive Site
Economic life circumstances [ Time Frame: a median follow-up of 27 months (range 16 - 40 months) after surgery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis
A Retrospective Follow-up of Patients After Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

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.

Endometriosis
  • 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).
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.
Interventions:
  • Procedure: multidisciplinary laparoscopy
  • Other: Questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Female
19 Years to 43 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00462176
ML2818 - 20/02/2006 a
No
Christel Meuleman, MD, University Hospitals Leuven, Leuven, Belgium
University Hospital, Gasthuisberg
Not Provided
Principal Investigator: Christel LC Meuleman, MD University Hospital Gasthuisberg, Leuven, Belgium
Study Director: Thomas D'Hooghe, MD, PhD University Hospital Gasthuisberg, Leuven, Belgium
University Hospital, Gasthuisberg
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP