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NCT01953250 Clinical Trial

Functional Outcome in Patients That Underwent Laparoscopic Sigmoid and/or Rectum Resection

Endometriosis Clinical Trial

Official title:
To Assess the Functional Outcome in Patients That Underwent Laparoscopic Sigmoid and/or Rectum Resection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01953250
Other study ID # S-54351
Secondary ID
Status Completed
Phase N/A
First received February 19, 2013
Last updated September 25, 2013
Start date June 2012
Est. completion date June 2013

Study information
Verified date April 2012
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial Summary

Questionnaire To assess the functional outcome in patients that underwent laparoscopic sigmoid and/or rectum resection.

Description:

A questionnaire will be sent to every patient by mail. The questionnaire that will be used is the COREFO questionnaire (ColoRectal Functional Outcome).

Depending on the amount of responses, we will try to make connections between peri-operative data and functional outcome after considerable period of follow-up. Peri-operative factors include grade of endometriosis, surgical technique and post-operative complications.

Recruitment information / eligibility
Status Completed
Enrollment 143
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium University Clinics Gasthuisberg Leuven Flemish Brabant

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary ColoRectal Functional Outcome Operation: between 1997 and 2011 Questionnaire to assess the colorectal function sent once in 2012 1 day No
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