Rectovaginal Fistula Repair

Fistula;Rectal Clinical Trial

Official title:

Rectovaginal Fistula Repair Predictors of Outcome and Results After Surgical Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05006586
• Other study ID #: RVF - quality of life
• Status: Completed
• Start date: September 15, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: August 2021
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Undergone RVF repair at Uppsala University Hospital 2003-2018

Exclusion Criteria:

• Fistula due to gender reconstructive surgery

Related Conditions & MeSH terms

• Fistula
• Fistula Vagina
• Fistula;Rectal
• Rectal Fistula
• Rectovaginal Fistula

Locations

Country	Name	City	State
Sweden	Akademiska Sjukhuset (Uppsala University hospital)	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical repair	Rate of fistula closure	Assessed on average 3 months postoperatively
Secondary	Health-related Quality-of-life	SF36 questionnaire	Through study completion, on average 10 years