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Fistula in AnoLATFIANCT05390151

Laser Assisted Treatment of Fistula In Ano

A study testing Laser treatment of anal fistula and RAF in people with Fistula in Ano and Rectal Fistula, run by University Hospital, Antwerp at 5 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Randomised Controlled Trial comparing Laser assisted closure of transsphincteric fistula to the rectal advancement flap. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Fistula in Ano, Rectal Fistula
What is being tested?
Laser treatment of anal fistula and RAF
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
5 sitesBelgium
Study dates
1 Mar 2022to 1 Mar 2026
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients with fistula involving more than one-third of the external anal sphincter
  • Single, continuous fistula tract at time of inclusion
  • Loose seton present in fistula tract for 2 months or more at time of inclusion
  • Age ≥ 18
  • Able to complete an informed written consent, understand its implications and contents, and participate in follow-up

Who cannot join

  • Fistula tract < 1 cm
  • Complex fistula tract system (branching of fistula tract inside the sphincter complex)
  • Pregnancy
  • HIV-positive
  • Crohn´s disease, Ulcerative colitis
  • Fistula due to malignancy
Show all 10Show fewer
  • Tuberculosis
  • Hidradenitis Suppurativa
  • No internal opening
  • Unable to undergo or contraindications to MRI

Trial locations and contacts

5 sites in 1 country.

Sander Van Hoof, M.D. contact

+3238212434

sander.vanhoof@uza.be

Niels Komen, M.D. Phd contact

+3238215007

niels.komen@uza.be

5 sites in 1 country

Belgium5 sites, 5 recruiting

  • Brussels University Hospital

    Brussels, 1090

    Jasper Stijns, MD

    Not yet recruiting

  • Antwerp University Hospital

    Edegem, Antwerpen, 2610

    Niels Komen, MD PhD, +3238215007, niels.komen@uza.be

    Recruiting

  • Az St Dimpna Geel

    Geel, Antwerpen, 2440

    Ben Gys, MD PhD

    Recruiting

  • Gent University Hospital

    Ghent, Oost- Vlaanderen, 9000

    Dirk Van De Putte, MD

    Not yet recruiting

  • Jessa Ziekenhuis Hasselt

    Hasselt, Limburg, 3500

    Bert Houben, MD

    Recruiting

Other trials in Belgium

About this study

Official title: LATFIA-trial: Laser Assisted Treatment of Fistula In Ano Randomized Controlled Trial Comparing FiLaCTM to Rectal Advancement Flap

Randomised Controlled Trial comparing Laser assisted closure of transsphincteric fistula to the rectal advancement flap.

Read the detailed description

A prevalent and complex fistula type is the high transsphincteric (TS) fistula. It typically runs through the upper two-thirds of the external anal sphincter (EAS) and is, due to the high risk of fecal incontinence, not suitable for fistulotomy and sphincter sparing treatment is required. To be included in this trial the participants should have a single, continuous TS fistula of cryptoglandular origin, that is treated by loose seton drainage for at least 2 months and is mapped by MRI. Participants with IBD, hidradenitis suppurativa or a malignant fistula will be excluded. Intervention Fistula Laser Closing (FiLaCTM) (Biolitec, Germany) is an endofistular technique, using a radial-emitting laser fiber that emits laser light with a maximum penetration depth of 2 - 3 mm. It destroys both the crypt gland and the additional epithelial layer of the fistula without damaging the sphincter. The fiber is inserted until the internal opening, activated and pulled backwards slowly, allowing the laser to have its effect. The external opening is excised and the internal opening is closed with a single absorbable suture. Rectal advancement flap is currently the gold standard for sphincter sparing treatment of high transsphincteric fistulae. The fistula is cored out and an advancement flap is made of mucosa and submucosa. The opening of the fistula in the flap is excised, the residual internal opening is closed with absorbable suture and the flap is sutured below the fistula to the anoderm. The advancement flap is a difficult technique that requires a relatively large transanal dissection that results in postoperative pain and may lead to disturbances in continence. Preliminary results with the Filac technique show fistula healing rates comparable to the advancement flap. Due to its simplicity, speed and minimal invasiveness the investigators expect a benefit for the participants in terms of postoperative pain, operating time and quality of life.

Being tested
Laser treatment of anal fistula, RAF
Keywords
Rectal, Advancement Flap, Laser assisted Fistula Closure, Randomised Control Trial
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 treatment of anal fistulaProcedure or surgery

    Also called FiLAC - LAFT

    using a radial laserprobe to treat transsphincteric fistula

  • RAFProcedure or surgery

    Also called rectal advancement flap

    current golden standard in transsphincteric fistula surgery

Study groups in NCT05390151
Study groupRoleWhat they receive
Laser assisted fistula closureActive comparatorGroup to be actively treated with laser assisted fistula surgery
Receives: Procedure: Laser treatment of anal fistula
Rectal advancement flapActive comparatorGroup to be actively treated with a rectal advancement flap.
Receives: Procedure: RAF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary fistula closure after index laser or flap treatment

    Success rate (number of patients) of laser/flap treatment defined as full healing (fistula closure) after the index procedure

    Measured: 6 months

Secondary outcomes (8)

  1. Secondary Fistula closure

    Secondary success rate (number of patients) defined as full healing (fistula closure) after a second procedure (either rectal advancement flap, laser treatment, fistulotomy)

    Measured: 6 months

  2. Postoperative Pain

    Reported pain after laser or flap treatment: measured using the visual analog scale - VAS where 0 = no pain; 10 = worst pain imaginable,

    Measured: 6 months

  3. Postoperative fecal incontinence

    Reported fecal incontinence after laser or flap treatment:

    measured using the Vaizey score where minimum score 0 = perfect continence; maximum score 24 = totally incontinent)

    Measured: 6 months

  4. Postoperative wound complications

    Reported wound complications after laser or flap treatment defined as wound dehiscence or bleeding as reported on the adverse event forms

    Measured: 6 months

  5. Postoperative Quality of Life

    General postoperative well being and ability to partake in daily life and daily tasks (specific role functioning) measured and scored using the SF 36 questionnaire (consisting of 8 weighted scales:

    vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role, functioning, and mental health. The lower the score the more disability. The higher the score the less disability)

    This outcome is measured in all participants after the initial procedure (index flap or laser treatment) as well as after a second procedure (in case of recurrence)

    Measured: 6 months

  6. Primary Recurrence

    Number of participants presenting with a clinical recurrence or residual fistula after initial and laser/flap treatment (index procedure)

    Measured: 6 months

  7. Secondary Recurrence

    Number of participants presenting with a clinical recurrence or residual fistula after the second procedure (Laser - Flap - Fistulotomy - Ligation of the fistula tract, video-assisted fistula treatment)

    Measured: 12 months

  8. Identify predictive factors for clinical fistula healing to determine the treatment indications.

    This outcome evaluates the correlations between patients'/ fistula's clinical characteristics and primary healing rates

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start1 Mar 2022
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

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
Masking
Single blind
Who is masked
Participant
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05390151
Sponsor's protocol ID
000202
Acronym
LATFIA
Status last verified
Mar 2022
First submitted
21 Apr 2022
Last updated
15 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gaillard M, Van den Broeck S, Op de Beeck B, Wouters K, Stijns J, Van de Putte D, Gys B, Houben B, Van Dessel E, Bislenghi G, Komen N. Protocol of the LATFIA trial (Laser Assisted Treatment of Fistula in Ano): a multicentre, prospective, randomized controlled trial comparing fistula-tract laser closure (FiLaC) with rectal advancement flap for high trans-sphincteric fistulas. Colorectal Dis. 2024 May;26(5):1038-1046. doi: 10.1111/codi.16951. Epub 2024 Mar 18.

    PubMed 38499516

Questions about this trial

What is this clinical trial studying?

A study testing Laser treatment of anal fistula and RAF in people with Fistula in Ano and Rectal Fistula, run by University Hospital, Antwerp at 5 sites in Belgium.

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 10 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: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium. 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?

Contact Sander Van Hoof, M.D. (+3238212434, sander.vanhoof@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary fistula closure after index laser or flap treatment (time frame: 6 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 NCT05390151, 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 15 Jun 2022.

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