Fistula in AnoNCT05666609
Fistula-in-ano in Infants and Children
A study testing placement of non-cutting seton (silicone) in people with Fistula in Ano, run by Friedrich-Alexander-Universität Erlangen-Nürnberg at 1 site in Germany.
Trial summary
In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Fistula in Ano
- What is being tested?
- placement of non-cutting seton (silicone)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- any patient with FIA and treatment with non-cutting seton placement in our institution
- regardless of underlying diagnoses
- age 0-18 years
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
Erlangen, Bavaria, 91054
Sonja Diez, M.D., 0049 09131 85 32923, sonja.diez@uk-erlangen.de
About this study
Official title: Fistula-in-ano in Infants and Children: Prospective, Randomized Clinical Trail on the Duration of Non-cutting Seton Placement
In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated.
Read the detailed description
In this prospective, randomized trail, patients are treated in case of fistula-in-ano with non-cutting seton placement. They are then randomized 1:1 in either Group A (duration of placed seton for 4 weeks) or Group B (duration of placed seton for 12 weeks). Patients are participating after informed consent is obtained.
- Conditions
- Fistula in Ano
- Being tested
- placement of non-cutting seton (silicone)
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placement of non-cutting seton (silicone)Procedure or surgery
Treatment of Fistula in ano is conducted according to the institution's treatment guidelines. Silicon seton placement is conducted under general anesthesia. Identification of the FIA is secured by the insertion of a bulb-headed lacrimal probe, on which a silicon vessel loop is attached and pulled through the entire fistulous tract. In case of a perianal abscess, drainage and sphincter-sparing debridement is performed followed by secondary wound healing. The loop is ligated loosely outside the anus without any additional tension to the skin. Duration of placed seton is depending on group assignment and is set to either 4 or 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 4weeks | Active comparator | Duration of placed seton 4 weeks Receives: Procedure: placement of non-cutting seton (silicone) |
| Group 12weeks | Active comparator | Duration of placed seton 12 weeks Receives: Procedure: placement of non-cutting seton (silicone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent fistula in ano
Measured: 6 months after initial surgery
Recurrent perianal abscess
Measured: 6 months after initial surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula in AnoStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: duration of placed seton 4 weeks Group B: duration of placed seton 12 weeks
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Sonja Diez, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Investigators
- Sonja Diez, MD, Principal investigator, Friedrich-Alexander-Universität Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666609
- Sponsor's protocol ID
- FIA2023-7
- Status last verified
- Aug 2025
- First submitted
- 18 Dec 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fistula-in-ano in Infants and Children: Prospective, Randomized Clinical Trail on the Duration of Non-cutting Seton Placement
- ClinicalTrials.gov ID
- NCT05666609
- Acronym / sponsor ID
- FIA2023-7
- Conditions
- Fistula in Ano
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-NürnbergUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Dec 2022 (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.
In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated.
Detailed description
In this prospective, randomized trail, patients are treated in case of fistula-in-ano with non-cutting seton placement. They are then randomized 1:1 in either Group A (duration of placed seton for 4 weeks) or Group B (duration of placed seton for 12 weeks). Patients are participating after informed consent is obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A: duration of placed seton 4 weeks Group B: duration of placed seton 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Group 4weeks | Active comparator | Procedure: placement of non-cutting seton (silicone)Duration of placed seton 4 weeks |
| Group 12weeks | Active comparator | Procedure: placement of non-cutting seton (silicone)Duration of placed seton 12 weeks |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- any patient with FIA and treatment with non-cutting seton placement in our institution
- regardless of underlying diagnoses
- age 0-18 years
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| placement of non-cutting seton (silicone)Treatment of Fistula in ano is conducted according to the institution's treatment guidelines. Silicon seton placement is conducted under general anesthesia. Identification of the FIA is secured by the insertion of a bulb-headed lacrimal probe, on which a silicon vessel loop is attached and pulled through the entire fistulous tract. In case of a perianal abscess, drainage and sphincter-sparing debridement is performed followed by secondary wound healing. The loop is ligated loosely outside the anus without any additional tension to the skin. Duration of placed seton is depending on group assignment and is set to either 4 or 12 weeks. | Procedure or surgery | Group 12weeks, Group 4weeks |
Primary outcome
Recurrent fistula in ano
Time frame: 6 months after initial surgery
Recurrent perianal abscess
Time frame: 6 months after initial surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Sonja Diez, MD principal investigator
Friedrich-Alexander-Universität Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing placement of non-cutting seton (silicone) in people with Fistula in Ano, run by Friedrich-Alexander-Universität Erlangen-Nürnberg at 1 site in Germany.
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 3 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonja Diez, MD (004991318532923, sonja.diez@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent fistula in ano (time frame: 6 months after initial surgery). The study lists 2 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 8 Sep 2025.