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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT01953250
Collaborator
(none)
143
Enrollment
1
Location
12
Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    143 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    To Assess the Functional Outcome in Patients That Underwent Laparoscopic Sigmoid and/or Rectum Resection
    Study Start Date :
    Jun 1, 2012
    Actual Primary Completion Date :
    Jun 1, 2013
    Actual Study Completion Date :
    Jun 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. ColoRectal Functional Outcome [1 day]

      Operation: between 1997 and 2011 Questionnaire to assess the colorectal function sent once in 2012

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Clinics Gasthuisberg Leuven Flemish Brabant Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT01953250
    Other Study ID Numbers:
    • S-54351
    First Posted:
    Sep 30, 2013
    Last Update Posted:
    Sep 30, 2013
    Last Verified:
    Apr 1, 2012
    Keywords provided by Universitaire Ziekenhuizen Leuven
    Deep infiltrating endometriosis
    Laparoscopic sigmoid resection
    laparoscopic rectum resection
    Colorectal surgery
    Additional relevant MeSH terms:
    Endometriosis

    Study Results

    No Results Posted as of Sep 30, 2013