Fistula-In-AnoNCT03017898
Treatment of Anal Fistula With Lasercoagulation
A study testing Laser Coagulation in people with Fistula-In-Ano and Anal Fistula, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether treatment with laser coagulation is an effective and safe treatment option for patients with anal fistula Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula-In-Ano, Anal Fistula
- What is being tested?
- Laser Coagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSweden
- Study dates
- 3 Mar 2017to Dec 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
- Subject must be at least 18 years of age
- Subject must have a verified anal fistula (by transanal ultrasound performed by treating surgeon)
- Subject must have a clean and infection-free fistula tract (no cavities seen on transanal ultrasound)
- Subject must be able to comply with study and study follow-up requirements.
Who cannot join
- Subject with anorectal fistula due to Crohn's disease
- Subject has an undrained abscess in fistula tract (cavities as seen on transanal ultrasound)
- Subject has fistula with side tracts (as seen on transanal ultrasound)
- Subject is unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Anal Fistula With Laser Mediated Heat Coagulation Using Fistula Laser Closure (FiLaC)
The purpose of this study is to determine whether treatment with laser coagulation is an effective and safe treatment option for patients with anal fistula
Read the detailed description
Treatment of anal fistula remains a challenge - the only truly effective treatment available (fistulotomy) involves very high rates of anal incontinence if performed on the majority of patients, and a vast number of alternative, sphincter-preserving treatments have been developed and evaluated in the past decades. The treatment of anal fistula with laser coagulation causes the fistula to collapse and subsequently heal, without having to add any external materials. The available published studies show that the treatment is safe regarding infection and incontinence, and that a majority of the patients treated show complete healing. There is however a need for more prospective studies to ascertain these preliminary facts.
- Conditions
- Fistula-In-Ano, Anal Fistula
- Being tested
- Laser Coagulation
- Keywords
- FiLaC, Fistula Laser Closure, Laser Coagulation
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser CoagulationProcedure or surgery
Also called Fistula Laser Closure (FiLaC)
Laser coagulation of anal fistula
| Study group | Role | What they receive |
|---|---|---|
| Laser coagulation | Experimental | Treatment of anal fistulae meeting the inclusion criteria Receives: Procedure: Laser Coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing
Fistula closure success at 12 months is defined as complete healing of the fistula tract and external opening at clinical examination and on a transanal ultrasound performed by the examining surgeon (yes/no).
Measured: 12 months
Secondary outcomes (2)
Infection
Rate of infection i.e. formation of abcess during the time of healing or thereafter within the first year of treatment.
Measured: 12 months
Incontinence
Presence of fecal incontinence as described by the patient
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start3 Mar 2017
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Study halted due to lower success rates than expected, under evaluation, will potentially resume at a later date.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fistula-In-AnoStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017898
- Sponsor's protocol ID
- FiLaC-2016
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2017
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilhelm A. A new technique for sphincter-preserving anal fistula repair using a novel radial emitting laser probe. Tech Coloproctol. 2011 Dec;15(4):445-9. doi: 10.1007/s10151-011-0726-0. Epub 2011 Aug 16.
PubMed 21845480Giamundo P, Esercizio L, Geraci M, Tibaldi L, Valente M. Fistula-tract Laser Closure (FiLaC): long-term results and new operative strategies. Tech Coloproctol. 2015 Aug;19(8):449-53. doi: 10.1007/s10151-015-1282-9. Epub 2015 Feb 28.
PubMed 25724967Giamundo P, Geraci M, Tibaldi L, Valente M. Closure of fistula-in-ano with laser--FiLaC: an effective novel sphincter-saving procedure for complex disease. Colorectal Dis. 2014 Feb;16(2):110-5. doi: 10.1111/codi.12440.
PubMed 24119103Ozturk E, Gulcu B. Laser ablation of fistula tract: a sphincter-preserving method for treating fistula-in-ano. Dis Colon Rectum. 2014 Mar;57(3):360-4. doi: 10.1097/DCR.0000000000000067.
PubMed 24509460
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anal Fistula With Laser Mediated Heat Coagulation Using Fistula Laser Closure (FiLaC)
- ClinicalTrials.gov ID
- NCT03017898
- Acronym / sponsor ID
- FiLaC-2016
- Conditions
- Fistula-In-Ano, Anal Fistula
- Keywords
- FiLaC, Fistula Laser Closure, Laser Coagulation
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study halted due to lower success rates than expected, under evaluation, will potentially resume at a later date.
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- 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 purpose of this study is to determine whether treatment with laser coagulation is an effective and safe treatment option for patients with anal fistula
Detailed description
Treatment of anal fistula remains a challenge - the only truly effective treatment available (fistulotomy) involves very high rates of anal incontinence if performed on the majority of patients, and a vast number of alternative, sphincter-preserving treatments have been developed and evaluated in the past decades. The treatment of anal fistula with laser coagulation causes the fistula to collapse and subsequently heal, without having to add any external materials. The available published studies show that the treatment is safe regarding infection and incontinence, and that a majority of the patients treated show complete healing. There is however a need for more prospective studies to ascertain these preliminary facts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser coagulation | Experimental | Procedure: Laser CoagulationTreatment of anal fistulae meeting the inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
- Subject must be at least 18 years of age
- Subject must have a verified anal fistula (by transanal ultrasound performed by treating surgeon)
- Subject must have a clean and infection-free fistula tract (no cavities seen on transanal ultrasound)
- Subject must be able to comply with study and study follow-up requirements.
Key exclusion criteria (4 listed)
- Subject with anorectal fistula due to Crohn's disease
- Subject has an undrained abscess in fistula tract (cavities as seen on transanal ultrasound)
- Subject has fistula with side tracts (as seen on transanal ultrasound)
- Subject is unable or unwilling to provide informed consent.
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 |
|---|---|---|
| Laser CoagulationAlso: Fistula Laser Closure (FiLaC)Laser coagulation of anal fistula | Procedure or surgery | Laser coagulation |
Primary outcome
Healing
Time frame: 12 months
Fistula closure success at 12 months is defined as complete healing of the fistula tract and external opening at clinical examination and on a transanal ultrasound performed by the examining surgeon (yes/no).
2 secondary outcomes
Infection
Time frame: 12 months
Incontinence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 21845480Wilhelm A. A new technique for sphincter-preserving anal fistula repair using a novel radial emitting laser probe. Tech Coloproctol. 2011 Dec;15(4):445-9. doi: 10.1007/s10151-011-0726-0. Epub 2011 Aug 16.
- Background: PubMed 25724967Giamundo P, Esercizio L, Geraci M, Tibaldi L, Valente M. Fistula-tract Laser Closure (FiLaC): long-term results and new operative strategies. Tech Coloproctol. 2015 Aug;19(8):449-53. doi: 10.1007/s10151-015-1282-9. Epub 2015 Feb 28.
- Background: PubMed 24119103Giamundo P, Geraci M, Tibaldi L, Valente M. Closure of fistula-in-ano with laser--FiLaC: an effective novel sphincter-saving procedure for complex disease. Colorectal Dis. 2014 Feb;16(2):110-5. doi: 10.1111/codi.12440.
- Background: PubMed 24509460Ozturk E, Gulcu B. Laser ablation of fistula tract: a sphincter-preserving method for treating fistula-in-ano. Dis Colon Rectum. 2014 Mar;57(3):360-4. doi: 10.1097/DCR.0000000000000067.
- 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. 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?
A study testing Laser Coagulation in people with Fistula-In-Ano and 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 5 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: paused, as of the sponsor's last update on 1 Mar 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?
Results are not available in the source record.
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?
Healing (time frame: 12 months). 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 NCT03017898, which also lists 4 linked publications.
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 1 Mar 2024.