Laser Assisted Treatment of Fistula In Ano

NCT ID: NCT05390151

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2026-03-01

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.

Conditions

Fistula in Ano; Rectal Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laser assisted fistula closure

Group to be actively treated with laser assisted fistula surgery

Group Type: ACTIVE_COMPARATOR

Laser treatment of anal fistula

Intervention Type: PROCEDURE

using a radial laserprobe to treat transsphincteric fistula

Rectal advancement flap

Group to be actively treated with a rectal advancement flap.

Group Type: ACTIVE_COMPARATOR

RAF

Intervention Type: PROCEDURE

current golden standard in transsphincteric fistula surgery

Interventions

Laser treatment of anal fistula

using a radial laserprobe to treat transsphincteric fistula

Intervention Type: PROCEDURE

RAF

current golden standard in transsphincteric fistula surgery

Intervention Type: PROCEDURE

Other Intervention Names

FiLAC - LAFT; rectal advancement flap

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: collaborator

AZ St.-Dimpna Geel

OTHER

Sponsor Role: collaborator

Jessa Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niels Komen, M.D. Phd

Role: STUDY_CHAIR

University Hospital, Antwerp

Sander Van Hoof, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

Antwerp University Hospital

Edegem, Antwerpen, Belgium

Site Status: RECRUITING

Az St Dimpna Geel

Geel, Antwerpen, Belgium

Site Status: RECRUITING

Jessa Ziekenhuis Hasselt

Hasselt, Limburg, Belgium

Site Status: RECRUITING

Gent University Hospital

Ghent, Oost- Vlaanderen, Belgium

Site Status: NOT_YET_RECRUITING

Brussels University Hospital

Brussels, , Belgium

Site Status: NOT_YET_RECRUITING

Countries

Belgium

Central Contacts

Sander Van Hoof, M.D.

Role: CONTACT

sander.vanhoof@uza.be

+3238212434

Niels Komen, M.D. Phd

Role: CONTACT

niels.komen@uza.be

+3238215007

Facility Contacts

Niels Komen, MD PhD

Role: primary

niels.komen@uza.be

+3238215007

Ben Gys, MD PhD

Role: primary

Bert Houben, MD

Role: primary

Dirk Van De Putte, MD

Role: primary

Jasper Stijns, MD

Role: primary

Other Identifiers

000202

Identifier Type: -

Identifier Source: org_study_id