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Rectovaginal Fistula Repair

Sponsor
Uppsala University (Other)
Overall Status
Completed
CT.gov ID
NCT05006586
Collaborator
(none)
55
Enrollment
1
Location
7
Actual Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a prospective evaluation of quality-of-life after rectovaginal fistula repair at our institution

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All patient having undergone rectovaginal fistula repair at Uppsala University Hospital 2003-2018. An invitation to join the study was sent to all patients. Those who answered were then sent Rand 36/SF36 questionnaire as a follow-up together with some general questions concerning whether the rectovaginal fistula was healed or not.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    55 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Rectovaginal Fistula Repair Predictors of Outcome and Results After Surgical Management
    Actual Study Start Date :
    Sep 15, 2020
    Actual Primary Completion Date :
    Mar 15, 2021
    Actual Study Completion Date :
    Apr 15, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    RVF

    All patients having undergone repair for rectovaginal fistula

    Outcome Measures

    Primary Outcome Measures

    1. Surgical repair [Assessed on average 3 months postoperatively]

      Rate of fistula closure

    Secondary Outcome Measures

    1. Health-related Quality-of-life [Through study completion, on average 10 years]

      SF36 questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Undergone RVF repair at Uppsala University Hospital 2003-2018
    Exclusion Criteria:
    • Fistula due to gender reconstructive surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Akademiska Sjukhuset (Uppsala University hospital) Uppsala Sweden 75185

    Sponsors and Collaborators

    • Uppsala University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Uppsala University
    ClinicalTrials.gov Identifier:
    NCT05006586
    Other Study ID Numbers:
    • RVF - quality of life
    First Posted:
    Aug 16, 2021
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Uppsala University
    Rectovaginal fistula
    Surgical repair
    Quality-of-life
    Additional relevant MeSH terms:
    Rectovaginal Fistula
    Rectal Fistula
    Fistula

    Study Results

    No Results Posted as of Aug 16, 2021