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

September 25, 2013 updated by: Universitaire Ziekenhuizen KU Leuven

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

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

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • University Clinics Gasthuisberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Infiltrating endometriosis
272 patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis, in the department of Abdominal Surgery, University Hospital Leuven, between the year 1997 and September 2011.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ColoRectal Functional Outcome
Time Frame: 1 day
Operation: between 1997 and 2011 Questionnaire to assess the colorectal function sent once in 2012
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: André JL D'Hoore, PhD, University Clinics Gasthuisberg Department of Abdominal Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

September 25, 2013

First Posted (Estimate)

September 30, 2013

Study Record Updates

Last Update Posted (Estimate)

September 30, 2013

Last Update Submitted That Met QC Criteria

September 25, 2013

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-54351

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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