Rectovaginal Fistula Repair | NCT05006586

Studies
Rectovaginal Fistula Repair

NCT05006586

Sponsor

Uppsala University

Status

Completed

Last Update Posted

Aug 16, 2021Actual

Enrollment

55Actual

Phase

Not provided

Conditions

Fistula Vagina
Fistula;Rectal

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2020Actual

Primary Completion Date

Mar 15, 2021Actual

Completion Date

Apr 15, 2021Actual

First Submitted Date

Jun 14, 2021

First Submission Date that Met QC Criteria

Aug 13, 2021

First Posted Date

Aug 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2021

Last Update Posted Date

Aug 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Label	Type	Description	Intervention Names
RVF		All patients having undergone repair for rectovaginal fistula

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergone RVF repair at Uppsala University Hospital 2003-2018

Exclusion Criteria:

Fistula due to gender reconstructive surgery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akademiska Sjukhuset (Uppsala University hospital)		Uppsala		75185	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35779081	Derived	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.

ID	Term
D014624	Vaginal Fistula
D012003	Rectal Fistula
D012006	Rectovaginal Fistula

ID	Term
D014623	Vaginal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications