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

NCT ID: NCT04418323

Last Updated: 2020-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-16

Study Completion Date

2021-06-02

Brief Summary

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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

Detailed Description

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Conditions

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Video Assisted Anal Fistula Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Video-assisted anal fistula treatment (VAAFT

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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)

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Conventional seton

Conventional seton in the Management of anal fistula

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Arnouse

Role: CONTACT

01099222561

Facility Contacts

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Mohamed Hamada Mohamed Hamada

Role: primary

+20 109 212 7930

Other Identifiers

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R.19.03.453 - 2019/03/11

Identifier Type: -

Identifier Source: org_study_id

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