Video-assisted Anal Fistula Treatment (VAAFT) Versus Fistula-tract Laser Closure (Filac) Versus Conventional Seton in the Management of Anal Fistula

Mansoura University

Status: Unknown

Conditions: Video Assisted Anal Fistula Treatment

Treatments: Procedure: Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula

Study type: Interventional

Funder types: Other

Identifiers

NCT04418323

R.19.03.453 - 2019/03/11

Details and patient eligibility

About

Anal fistula is a chronic inflammatory tract connecting an internal opening in the anal canal with one or more than one external openings in the perianal skin Aim of the work This prospective randomized control trial, we will compare video-assisted anal fistula treatment (Vaaft) and Fistula Laser closure (Filac) and conventional Seton as regards, recurrence rate as a primary outcome. Secondary outcome includes; operative and post-operative data, hospital stay, pain score, healing time, return to work and continence

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both genders aging between 18-65 years with cryptoglandular anal fistula will be included.

Exclusion criteria

• We will exclude patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases, and patients on long acting corticosteroids or immunosuppressive drugs will be also excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Video-assisted anal fistula treatment (VAAFT

Active Comparator group

Description:

Video-assisted anal fistula treatment (VAAFT) in the Management of anal fistula

Treatment:

Procedure: Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula

Fistula-tract Laser Closure (filac)

Active Comparator group

Description:

Fistula-tract Laser Closure (filac)in the Management of anal fistula

Treatment:

Procedure: Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula

Conventional seton

Active Comparator group

Description:

Conventional seton in the Management of anal fistula

Treatment:

Procedure: Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula