Fistula;RectalNCT03297138
Fistula Laser Closure
An observational study of Fistula;Rectal, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The anal complex fistula constitutes a challenge in proctologic surgery because of the of its therapeutic care complexity due to the frequency of recurrences and the necessity to protect the sphincter function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula;Rectal
- What is being tested?
- FiLAC laser
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2016to 31 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient having a surgical indication using FiLAC laser technique
Who may be able to join
- Patient with anal fistula drained at least 3 months before inclusion.
Who cannot join
- Fistula not well drained
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The anal complex fistula constitutes a challenge in proctologic surgery because of the of its therapeutic care complexity due to the frequency of recurrences and the necessity to protect the sphincter function.
For several years,differents techniques were developed "said sphincter sparing techniques" to handle fistulas at risk on the anal continence.
Recently there is one of them , named FiLAC using a clip system not yet evaluated.
The purpose is to assess the success rate of his new surgery technique.
- Conditions
- Fistula;Rectal
- Being tested
- FiLAC laser
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiLAC laserProcedure or surgery
The technique consists in applying in a radial way to 360 ° an energy laser in the fistulous route. This energy allows a thermal destruction by coagulation of the wall of the fistula and the fabrics of granulations in a circular and regular way as well as a shrinkage of neighbouring fabrics. The repair is made by a call of macrophages and fibroblasts of neighbouring healthy fabrics so ending in a closure of the fistulous route
What is being measured
The primary outcome is the main question the study is designed to answer.
surgery success rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start16 Sep 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula;RectalStudies 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
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297138
- Sponsor's protocol ID
- FILAC
- Status last verified
- May 2018
- First submitted
- 25 Sep 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fistula Laser Closure
- ClinicalTrials.gov ID
- NCT03297138
- Acronym / sponsor ID
- FILAC
- Conditions
- Fistula;Rectal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 16 Sep 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 29 Sep 2017 (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 anal complex fistula constitutes a challenge in proctologic surgery because of the of its therapeutic care complexity due to the frequency of recurrences and the necessity to protect the sphincter function.
For several years,differents techniques were developed "said sphincter sparing techniques" to handle fistulas at risk on the anal continence.
Recently there is one of them , named FiLAC using a clip system not yet evaluated.
The purpose is to assess the success rate of his new surgery technique.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient having a surgical indication using FiLAC laser technique
Key inclusion criteria (1 listed)
- Patient with anal fistula drained at least 3 months before inclusion.
Key exclusion criteria (1 listed)
- Fistula not well drained
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 |
|---|---|---|
| FiLAC laserThe technique consists in applying in a radial way to 360 ° an energy laser in the fistulous route. This energy allows a thermal destruction by coagulation of the wall of the fistula and the fabrics of granulations in a circular and regular way as well as a shrinkage of neighbouring fabrics. The repair is made by a call of macrophages and fibroblasts of neighbouring healthy fabrics so ending in a closure of the fistulous route | Procedure or surgery | – |
Primary outcome
surgery success rate
Time frame: 6 months
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 30 May 2018.
- 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.
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;Rectal, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 30 May 2018. 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 France. 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?
surgery success rate (time frame: 6 months). 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 30 May 2018.