Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis

NCT00462176 | Completed

• 1 other identifier: ML2818 - 20/02/2006 a
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

colorectal endometriosis; deep infiltrating endometriosis; dysmenorroe; dyspareunia; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Economic life circumstances

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

Study Arms (1)

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; Other: Questionnaires

Interventions

multidisciplinary laparoscopy PROCEDURE

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

1

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).

1

Eligibility Criteria

• Age: 19 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients without bowel resection

Sponsors & Collaborators

• University Hospital, Gasthuisberg: lead

Study Sites (1)

University Hospital Gasthuisberg

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Endometriosis; Dyspareunia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Christel LC Meuleman, MD

  University Hospital Gasthuisberg, Leuven, Belgium

  PRINCIPAL INVESTIGATOR

• Thomas D'Hooghe, MD, PhD

  University Hospital Gasthuisberg, Leuven, Belgium

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: September 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 20, 2009

Record last verified: 2009-02

Locations

BE (1)