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Surgical Treatment of High Perianal Fistulas

NCT01997645 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2013-11-28

No results posted yet for this study

Summary

Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the third and fourth decade of life. According to Parks classification fistulas have been divided into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. Simple fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high (transsphincteric) fistulas it may affect anal continence seriously.

Therefore sphincter preserving procedures should be preferred in these cases. Rectal advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication with high success rate in cryptoglandular fistulas. However, this technique is technically demanding and results can be expert depended with wide spread of healing rates (24-100%) in individual studies as referred in recent systematic review.

Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple sphincter preserving technique. The success rate varies between 40-95% with low overall incontinence rate (6%).

The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment of high perianal fistulas.

Conditions

  • Anal Fistula
  • Rectal Fistula

Interventions

PROCEDURE

LIFT

PROCEDURE

RAF

Sponsors & Collaborators

  • University Hospital Hradec Kralove

    lead OTHER

Principal Investigators

  • Július Örhalmi, MD · University Hospital Hradec Kralove

  • Zuzana Šerclová, MD · Central MIlitary Hospital Prague

  • Karel Klos, MD · District Hospital Nový Jičín

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-06-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01997645 on ClinicalTrials.gov