Laser Assisted Treatment of Fistula In Ano (LATFIA)

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Fistula; Fistula in Ano
• Intervention / Treatment: Procedure: Laser treatment of anal fistula; Procedure: RAF

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 Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sander Van Hoof, M.D.; Phone Number: +3238212434; Email: sander.vanhoof@uza.be
• Study Contact Backup: Name: Niels Komen, M.D. Phd; Phone Number: +3238215007; Email: niels.komen@uza.be

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Not yet recruiting
    • Brussels University Hospital
    • Contact: Jasper Stijns, MD
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2610
      • Recruiting
      • Antwerp University Hospital
      • Contact: Niels Komen, MD PhD; Phone Number: +3238215007; Email: niels.komen@uza.be
    • Geel, Antwerpen, Belgium, 2440
      • Recruiting
      • Az St Dimpna Geel
      • Contact: Ben Gys, MD PhD
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Ziekenhuis Hasselt
      • Contact: Bert Houben, MD
  • Oost- Vlaanderen
    • Gent, Oost- Vlaanderen, Belgium, 9000
      • Not yet recruiting
      • Gent University Hospital
      • Contact: Dirk Van De Putte, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: rectal advancement flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months
Postoperative Pain	Reported pain after laser or flap treatment: measured using the visual analog scale - VAS where 0 = no pain; 10 = worst pain imaginable,	6 months
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)	6 months
Postoperative wound complications	Reported wound complications after laser or flap treatment defined as wound dehiscence or bleeding as reported on the adverse event forms	6 months
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)	6 months
Primary Recurrence	Number of participants presenting with a clinical recurrence or residual fistula after initial and laser/flap treatment (index procedure)	6 months
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)	12 months
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	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Jessa Hospital; University Hospital, Ghent; Universitair Ziekenhuis Brussel; AZ St.-Dimpna Geel
• Investigators: Study Chair: Niels Komen, M.D. Phd, University Hospital, Antwerp; Principal Investigator: Sander Van Hoof, M.D., University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Randomised Control Trial; Rectal, Advancement Flap; Laser assisted Fistula Closure
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: 000202 (Astrazeneca)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No