Rectovaginal Fistula Repair

Completed

• Conditions: Fistula Vagina; Fistula;Rectal

• Registration Number: NCT05006586
• Lead Sponsor: Uppsala University

Brief Summary

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

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 Timeline

• Study Start: 2020-09-15
• Primary Completion: 2021-03-15
• Study Completion: 2021-04-15
• Study First Submitted: 2021-06-14
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-13
• Last Update Submitted: 2021-08-13
• Study First Posted: 2021-08-16
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

• Undergone RVF repair at Uppsala University Hospital 2003-2018

Exclusion Criteria

• Fistula due to gender reconstructive surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical repair	Assessed on average 3 months postoperatively	Rate of fistula closure

Secondary Outcome Measures

Name	Time	Method
Health-related Quality-of-life	Through study completion, on average 10 years	SF36 questionnaire

Trial Locations

Locations (1)

Akademiska Sjukhuset (Uppsala University hospital); 🇸🇪 Uppsala, Sweden