NCT05006586

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

June 14, 2021

Last Update Submit

August 13, 2021

Conditions

Fistula VaginaFistula;Rectal

Keywords

Rectovaginal fistulaSurgical repairQuality-of-life

Outcome Measures

Primary Outcomes (1)

  • Surgical repair

    Rate of fistula closure

    Assessed on average 3 months postoperatively

Secondary Outcomes (1)

  • Health-related Quality-of-life

    Through study completion, on average 10 years

Study Arms (1)

RVF

All patients having undergone repair for rectovaginal fistula

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Undergone RVF repair at Uppsala University Hospital 2003-2018

You may not qualify if:

  • Fistula due to gender reconstructive surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akademiska Sjukhuset (Uppsala University hospital)

Uppsala, 75185, Sweden

Location

Related Publications (1)

  • Soderqvist EV, Cashin PH, Graf W. Surgical treatment of rectovaginal fistula-predictors of outcome and effects on quality of life. Int J Colorectal Dis. 2022 Jul;37(7):1699-1707. doi: 10.1007/s00384-022-04206-7. Epub 2022 Jul 2.

    PMID: 35779081DERIVED

MeSH Terms

Conditions

Vaginal FistulaRectal FistulaRectovaginal Fistula

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

August 16, 2021

Study Start

September 15, 2020

Primary Completion

March 15, 2021

Study Completion

April 15, 2021

Last Updated

August 16, 2021

Record last verified: 2021-08

Locations

SE(1)