Clinical trial NCT00462176: Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis
Official title: A Retrospective Follow-up of Patients After Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: colorectal endometriosis
deep infiltrating endometriosis
dysmenorroe
dyspareunia
quality of life
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 45
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Pain; Sexuality; Quality of life; Fertility rate; Complication rate; Recurrence rate
timeFrame: a median follow-up of 27 months (range 16 - 40 months) after surgery
Secondary outcomes:
measure: Economic life circumstances
timeFrame: a median follow-up of 27 months (range 16 - 40 months) after surgery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
Study officials:
affiliation: University Hospital Gasthuisberg, Leuven, Belgium
name: Christel LC Meuleman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Gasthuisberg, Leuven, Belgium
name: Thomas D'Hooghe, MD, PhD
role: STUDY_DIRECTOR
References: