Clinical trial NCT05390151: Laser Assisted Treatment of Fistula In Ano
Official title: LATFIA-trial: Laser Assisted Treatment of Fistula In Ano Randomized Controlled Trial Comparing FiLaCTM to Rectal Advancement Flap
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fistula in Ano
Rectal Fistula
Keywords: Rectal, Advancement Flap
Laser assisted Fistula Closure
Randomised Control Trial
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universitair Ziekenhuis Brussel
name: University Hospital, Ghent
name: AZ St.-Dimpna Geel
name: Jessa Hospital
First posted: 2022-05-25
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Primary fistula closure after index laser or flap treatment
timeFrame: 6 months
Secondary outcomes:
measure: Secondary Fistula closure
timeFrame: 6 months
measure: Postoperative Pain
timeFrame: 6 months
measure: Postoperative fecal incontinence
timeFrame: 6 months
measure: Postoperative wound complications
timeFrame: 6 months
measure: Postoperative Quality of Life
timeFrame: 6 months
measure: Primary Recurrence
timeFrame: 6 months
measure: Secondary Recurrence
timeFrame: 12 months
measure: Identify predictive factors for clinical fistula healing to determine the treatment indications.
timeFrame: 6 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerpen
city: Geel
country: Belgium
facility: Az St Dimpna Geel
state: Antwerpen
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis Hasselt
state: Limburg
city: Gent
country: Belgium
facility: Gent University Hospital
state: Oost- Vlaanderen
city: Brussels
country: Belgium
facility: Brussels University Hospital
Study officials:
affiliation: University Hospital, Antwerp
name: Niels Komen, M.D. Phd
role: STUDY_CHAIR
affiliation: University Hospital, Antwerp
name: Sander Van Hoof, M.D.
role: PRINCIPAL_INVESTIGATOR
References: