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CompletedNCT05006586Updated Aug 16, 2021

Rectovaginal Fistula Repair

An observational study in Fistula Vagina and Fistula;Rectal, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to female participants. Per ClinicalTrials.gov, last updated 2021-08-16.

Sponsored by Uppsala University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
55
Sex
Female
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Study summary

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

Read the 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.

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Conditions studied

  • Fistula Vagina
  • Fistula;Rectal

Keywords

  • Rectovaginal fistula
  • Surgical repair
  • Quality-of-life
03

In context

Rectal Fistula

189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.

This study's enrollment of 55 is below the median of 94 across 50 observational studies indexed under Rectal Fistula.

Browse Rectal Fistula studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Undergone RVF repair at Uppsala University Hospital 2003-2018

Exclusion criteria

Exclusion Criteria:

  • Fistula due to gender reconstructive surgery
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
55 participants (actual)
Patient registry
No

Groups and cohorts

  • RVF

    All patients having undergone repair for rectovaginal fistula

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What researchers measure

Primary outcomes

  1. Surgical repair

    Rate of fistula closure

    Time frame: Assessed on average 3 months postoperatively

Secondary outcomes

  1. Health-related Quality-of-life

    SF36 questionnaire

    Time frame: Through study completion, on average 10 years

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Study locations

1 site
  • Akademiska Sjukhuset (Uppsala University hospital)
    Uppsala, 75185, Sweden
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References and documents

Publications

  • 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. PubMed 35779081 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05006586
Lead sponsor
Uppsala University
Responsible party
Sponsor
First posted
Aug 16, 2021
Start date
Sep 15, 2020
Primary completion
Mar 15, 2021
Completion
Apr 15, 2021
Last update
Aug 16, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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