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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04418323
Other study ID # R.19.03.453 - 2019/03/11
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 16, 2020
Est. completion date June 2, 2021

Study information

Verified date May 2020
Source Mansoura University
Contact Mohamed Arnouse
Phone 01099222561
Email drmhamdy@mans.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 2, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Egypt Mansoura University Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary recurrence of anal fistula recurrence of anal fistula symptoms one year