Anal FistulaUFUNCT03937752
3D Endoanal Ultrasound and Anal Fistula
An observational study of Anal Fistula, run by Region Skane at 1 site in Sweden.
Trial summary
The study aims to evaluate the use of 3D endoanal ultrasound in preoperative management of anal fistula disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anal Fistula
- What is being tested?
- 3D endodanal ultrasound
- How many people
- 95 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2018to 24 Jan 2023
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly diagnosed anal fistula with no previous anal fistula procedures.
Who may be able to join
- anal fistula
- no previous fistula procedures
Who cannot join
- previous fistula procedures
- ano/rectovaginal fistula
- inflammatory bowel disease
- more than one internal openings
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of 3D Endoanal Ultrasound in Management of Anal Fistulas
The study aims to evaluate the use of 3D endoanal ultrasound in preoperative management of anal fistula disease.
- Conditions
- Anal Fistula
- Being tested
- 3D endodanal ultrasound
- Keywords
- anal fistula, fistula in ano, endoanal ultrasound, 3D ultrasound, 3D ultrasonography, endoanal ultrasonography, diagnostics
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D endodanal ultrasoundOther
Also called 3D endoanal ultrasonography
Endoanal ultrasound performed with two different transducers preoperatively during a fistula treatment procedure.
| Study group | Role | What they receive |
|---|---|---|
| Anal fistula | Patients with anal fistulas, no previous fistula procedures. Ultrasound investigation done as a part of surgical treatment, such as loose seton or fistulotomy. Receives: Other: 3D endodanal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula position
Dorsal? Ventral? Lateral - right or left?
Measured: Day 1
Fistula level
Level I-IV (how much of the sphincter is affected?)
Measured: Day 1
Fistula length
Shorter or longer than 3 cm?
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Apr 2018
- Primary completion26 Mar 2020
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ursula Aho Fält, MD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937752
- Sponsor's protocol ID
- Ultrasound study 2018/201
- Acronym
- UFU
- Status last verified
- Feb 2024
- First submitted
- 29 Apr 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 3D Endoanal Ultrasound in Management of Anal Fistulas
- ClinicalTrials.gov ID
- NCT03937752
- Acronym / sponsor ID
- UFU / Ultrasound study 2018/201
- Conditions
- Anal Fistula
- Keywords
- anal fistula, fistula in ano, endoanal ultrasound, 3D ultrasound, 3D ultrasonography, endoanal ultrasonography, diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 6 May 2019 (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.
The study aims to evaluate the use of 3D endoanal ultrasound in preoperative management of anal fistula disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anal fistula | – | Other: 3D endodanal ultrasoundPatients with anal fistulas, no previous fistula procedures. Ultrasound investigation done as a part of surgical treatment, such as loose seton or fistulotomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly diagnosed anal fistula with no previous anal fistula procedures.
Key inclusion criteria (2 listed)
- anal fistula
- no previous fistula procedures
Key exclusion criteria (4 listed)
- previous fistula procedures
- ano/rectovaginal fistula
- inflammatory bowel disease
- more than one internal openings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D endodanal ultrasoundAlso: 3D endoanal ultrasonographyEndoanal ultrasound performed with two different transducers preoperatively during a fistula treatment procedure. | Other | Anal fistula |
Primary outcome
Fistula position
Time frame: Day 1
Dorsal? Ventral? Lateral - right or left?
Fistula level
Time frame: Day 1
Level I-IV (how much of the sphincter is affected?)
Fistula length
Time frame: Day 1
Shorter or longer than 3 cm?
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 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ursula Aho Fält, MD principal investigator
Region Skane
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 Anal Fistula, run by Region Skane 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 2 inclusion and 4 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 28 Feb 2024. 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?
Fistula position (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.