Fistula VaginaNCT05006586
Rectovaginal Fistula Repair
An observational study of Fistula Vagina and Fistula;Rectal, run by Uppsala University at 1 site in Sweden.
Trial summary
This study is a prospective evaluation of quality-of-life after rectovaginal fistula repair at our institution Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fistula Vagina, Fistula;Rectal
- How many people
- 55 participants
- Where
- 1 siteSweden
- Study dates
- 15 Sep 2020to 15 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women undergoing RVF repair att Uppsala University Hospital. A quality-of-life follow-up is planned.
Who may be able to join
- Undergone RVF repair at Uppsala University Hospital 2003-2018
Who cannot join
- Fistula due to gender reconstructive surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rectovaginal Fistula Repair Predictors of Outcome and Results After Surgical Management
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.
- Conditions
- Fistula Vagina, Fistula;Rectal
- Keywords
- Rectovaginal fistula, Surgical repair, Quality-of-life
- Medical subject headings
- Vaginal Fistula, Rectal Fistula, Rectovaginal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RVF | All patients having undergone repair for rectovaginal fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical repair
Rate of fistula closure
Measured: Assessed on average 3 months postoperatively
Secondary outcomes (1)
Health-related Quality-of-life
SF36 questionnaire
Measured: Through study completion, on average 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start15 Sep 2020
- Primary completion15 Mar 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fistula VaginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006586
- Sponsor's protocol ID
- RVF - quality of life
- Status last verified
- Aug 2021
- First submitted
- 14 Jun 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectovaginal Fistula Repair Predictors of Outcome and Results After Surgical Management
- ClinicalTrials.gov ID
- NCT05006586
- Acronym / sponsor ID
- RVF - quality of life
- Conditions
- Fistula Vagina, Fistula;Rectal
- Keywords
- Rectovaginal fistula, Surgical repair, Quality-of-life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RVF | – | –All patients having undergone repair for rectovaginal fistula |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women undergoing RVF repair att Uppsala University Hospital. A quality-of-life follow-up is planned.
Key inclusion criteria (1 listed)
- Undergone RVF repair at Uppsala University Hospital 2003-2018
Key exclusion criteria (1 listed)
- Fistula due to gender reconstructive surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical repair
Time frame: Assessed on average 3 months postoperatively
Rate of fistula closure
1 secondary outcome
Health-related Quality-of-life
Time frame: Through study completion, on average 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Derived from this study: PubMed 35779081Soderqvist 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fistula Vagina and Fistula;Rectal, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical repair (time frame: Assessed on average 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05006586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.