The anal fistula PLUG versus the mucosal flap advancement for the treatment of perianal fistulas

Completed

• Conditions: Digestive System; Perianal fistula; Diseases of digestive system

• Registration Number: ISRCTN97376902
• Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1.High anorectal fistula of cryptoglandular origin (transphincteric, upper 2/3 of the sphincter complex which is confined by the puborectal sling and the end of the anal canal)
2. Informed consent

Exclusion Criteria

1. Aged less than 18 years
2. Human Immunodeficiency Virus (HIV)-positive
3. Crohn's disease
4. Malignant cause
5. Tuberculosis
6. Hidradenitis suppurativa
7. Pilonidal sinus disease
8. No internal opening found during surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Anorectal fistula closure rate<br>2. Continence

Secondary Outcome Measures

Name	Time	Method
1. Morbidity<br>2. Post-operative pain<br>3. Sick leave<br>4. Quality of life