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Seton or Glue for Trans-sphincteric Anal Fistulas

NCT00929630 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2009-09-16

No results posted yet for this study

Summary

Surgical treatment of perianal fistulas frequently affects fecal continence. Sphincter saving techniques like loose or cutting seton and fistulectomy with advancement of an endorectal flap have been advocated to minimize the risk of sphincter injury, but patients often complain of a prolonged healing period and major discomfort. Furthermore, the healing rate varies widely according to the type of fistula and the surgeon's experience.In the early '90s the treatment of perianal fistulas by autologous or commercial fibrin glue was suggested and the American FDA approved the use and marketing of a human fibrin glue in 1998.

Since then, several studies have evaluated the effectiveness of human fibrin glue in the treatment of different types of perianal fistulas, reporting a wide range of success rates ranging from 31 to 85%.

Primary aim of this study is to conduct a prospective randomized trial evaluating the effectiveness of glue treatment of perianal fistulas as compared with the classical seton treatment. Secondary aims are to compare postoperative faecal incontinence, postoperative anal pain, healing time and length of hospitalization.

Conditions

  • Anal Fistulas

Interventions

PROCEDURE

transsphincteric Seton positioning

A cutting seton is applied into the fistula tract

PROCEDURE

glue (Tissucol) treatment

After preparation of the fistula, a quantity of biological glue (Tissucol) is injected into the fistula tract

PROCEDURE

Fistula closing with biological glue

After cleaning and disinfection of the fistula tract, abot 1-2 ml of Tissucol (biological Glue) is inserted into the fistula tract to close it

PROCEDURE

Seton positioning into the fistula tract

Under spinal anesthesia a Seton is positioned into the fistula tract.

Sponsors & Collaborators

  • Societa Italiana di Chirurgia ColoRettale

    lead NETWORK

Principal Investigators

  • Donato F Altomare, MD · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-05-31
Completion
2007-06-30

Countries

  • Italy

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 NCT00929630 on ClinicalTrials.gov