Rectovaginal Fistula Repair

August 13, 2021 updated by: Uppsala University

Rectovaginal Fistula Repair Predictors of Outcome and Results After Surgical Management

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

55

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

  • Sweden
      • Uppsala, Sweden, 75185
        • Akademiska Sjukhuset (Uppsala University hospital)

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

Women undergoing RVF repair att Uppsala University Hospital. A quality-of-life follow-up is planned.

Description

Inclusion Criteria:

  • Undergone RVF repair at Uppsala University Hospital 2003-2018

Exclusion Criteria:

  • Fistula due to gender reconstructive surgery

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
RVF
All patients having undergone repair for rectovaginal fistula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical repair
Time Frame: Assessed on average 3 months postoperatively
Rate of fistula closure
Assessed on average 3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality-of-life
Time Frame: Through study completion, on average 10 years
SF36 questionnaire
Through study completion, on average 10 years

Collaborators and Investigators

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

Sponsor

Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 15, 2020

Primary Completion (Actual)

March 15, 2021

Study Completion (Actual)

April 15, 2021

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

August 13, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVF - quality of life

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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