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Completed

NCT Number: NCT00462176

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.

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Key information

Conditions

Endometriosis Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

19 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Gasthuisberg

Leuven, 3000, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multidisciplinary laparoscopy

Procedure

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

questionnaires

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. Economic life circumstances

    Time frame: a median follow-up of 27 months (range 16 - 40 months) after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Gasthuisberg

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Apr 18, 2007
Registry last updated
Feb 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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