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Laser Assisted Treatment of Fistula In Ano (LATFIA)

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ClinicalTrials.gov Identifier: NCT05390151
Recruitment Status : Recruiting
First Posted : May 25, 2022
Last Update Posted : June 15, 2022
Sponsor:
Collaborators:
Universitair Ziekenhuis Brussel
University Hospital, Ghent
AZ St.-Dimpna Geel
Jessa Hospital
Information provided by (Responsible Party):
University Hospital, Antwerp

Study Description
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Brief Summary:
Randomised Controlled Trial comparing Laser assisted closure of transsphincteric fistula to the rectal advancement flap.

Condition or disease Intervention/treatment Phase
Fistula in Ano Rectal Fistula Procedure: Laser treatment of anal fistula Procedure: RAF Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: LATFIA-trial: Laser Assisted Treatment of Fistula In Ano Randomized Controlled Trial Comparing FiLaCTM to Rectal Advancement Flap
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : March 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Laser assisted fistula closure
Group to be actively treated with laser assisted fistula surgery
 Procedure: Laser treatment of anal fistula
using a radial laserprobe to treat transsphincteric fistula
Other Name: FiLAC - LAFT
Active Comparator: Rectal advancement flap
Group to be actively treated with a rectal advancement flap.
 Procedure: RAF
current golden standard in transsphincteric fistula surgery
Other Name: rectal advancement flap


Outcome Measures
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Primary Outcome Measures :
  1. Primary fistula closure after index laser or flap treatment [ Time Frame: 6 months ]
    Success rate (number of patients) of laser/flap treatment defined as full healing (fistula closure) after the index procedure


Secondary Outcome Measures :
  1. Secondary Fistula closure [ Time Frame: 6 months ]
    Secondary success rate (number of patients) defined as full healing (fistula closure) after a second procedure (either rectal advancement flap, laser treatment, fistulotomy)

  2. Postoperative Pain [ Time Frame: 6 months ]
    Reported pain after laser or flap treatment: measured using the visual analog scale - VAS where 0 = no pain; 10 = worst pain imaginable,

  3. Postoperative fecal incontinence [ Time Frame: 6 months ]

    Reported fecal incontinence after laser or flap treatment:

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


  4. Postoperative wound complications [ Time Frame: 6 months ]
    Reported wound complications after laser or flap treatment defined as wound dehiscence or bleeding as reported on the adverse event forms

  5. Postoperative Quality of Life [ Time Frame: 6 months ]

    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)


  6. Primary Recurrence [ Time Frame: 6 months ]
    Number of participants presenting with a clinical recurrence or residual fistula after initial and laser/flap treatment (index procedure)

  7. Secondary Recurrence [ Time Frame: 12 months ]
    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)

  8. Identify predictive factors for clinical fistula healing to determine the treatment indications. [ Time Frame: 6 months ]
    This outcome evaluates the correlations between patients'/ fistula's clinical characteristics and primary healing rates


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Tuberculosis
  • Hidradenitis Suppurativa
  • No internal opening
  • Unable to undergo or contraindications to MRI
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05390151


Contacts
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Contact: Sander Van Hoof, M.D. +3238212434 sander.vanhoof@uza.be
Contact: Niels Komen, M.D. Phd +3238215007 niels.komen@uza.be

Locations
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Belgium
Antwerp University Hospital Recruiting
Edegem, Antwerpen, Belgium, 2610
Contact: Niels Komen, MD PhD    +3238215007    niels.komen@uza.be   
Az St Dimpna Geel Recruiting
Geel, Antwerpen, Belgium, 2440
Contact: Ben Gys, MD PhD         
Jessa Ziekenhuis Hasselt Recruiting
Hasselt, Limburg, Belgium, 3500
Contact: Bert Houben, MD         
Gent University Hospital Not yet recruiting
Gent, Oost- Vlaanderen, Belgium, 9000
Contact: Dirk Van De Putte, MD         
Brussels University Hospital Not yet recruiting
Brussels, Belgium, 1090
Contact: Jasper Stijns, MD         
Sponsors and Collaborators
University Hospital, Antwerp
Universitair Ziekenhuis Brussel
University Hospital, Ghent
AZ St.-Dimpna Geel
Jessa Hospital
Investigators
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Study Chair: Niels Komen, M.D. Phd University Hospital, Antwerp
Principal Investigator: Sander Van Hoof, M.D. University Hospital, Antwerp
More Information
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Responsible Party: University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT05390151    
Other Study ID Numbers: 000202
First Posted: May 25, 2022    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Antwerp:
Rectal, Advancement Flap
Laser assisted Fistula Closure
Randomised Control Trial
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
 Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases