Seton or Glue for Trans-sphincteric Anal Fistulas
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Background: Fibrin glue treatment of anal fistulas has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because clear data in literature are lacking. We will run a prospective randomised trial comparing commercial fibrin glue treatment with classical seton treatment, taking into account the healing rate, hospital stay, healing time, faecal incontinence and postoperative pain.
Patients and Methods: 130 homogeneous patients with trans-sphincteric anal fistulas referred to 7 Colorectal Units will be randomised to undergo fibrin glue or seton treatment. permanent healing of the fistula will be defined as absence on any discharge from the fistula and healing of the secondary fistula orifice after at least 1 year of follow up.
Post operative pain (on a VAS scale) and hospital stay will be recorded and compared in the two groups
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: glue (Tissucol ) treatment patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before |
Procedure: glue (Tissucol) treatment
After preparation of the fistula, a quantity of biological glue (Tissucol) is injected into the fistula tract
Other Names:
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
Other Names:
|
| Active Comparator: Seton treatment patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before |
Procedure: transsphincteric Seton positioning
A cutting seton is applied into the fistula tract
Other Names:
Procedure: Seton positioning into the fistula tract
Under spinal anesthesia a Seton is positioned into the fistula tract.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Fistula healing (absence of any discharge from the external fistula opening and complete healing of the external fistulas opening after at least 1 year of follow-up). The analysis of the population is not intention to treat. [12 months]
Secondary Outcome Measures
- Fecal continence and in-hospital stay [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
- medium or high trans-sphincteric fistulas of cryptoglandular origin, no previous treatments
Exclusion Criteria:
-
Crohn's disease
-
anal abscesses
-
complex fistulas (horse-shoe type or multiple secondary tracts)
-
immunosuppression
-
diabetes,
-
anal fissures
-
pregnancy
-
anti-coagulant treatments,
-
any allergic reaction to the bioglue components.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept of Emergency and Organ transplantation - University of Bari | Bari | Italy | 70124 |
Sponsors and Collaborators
- Societa Italiana di Chirurgia ColoRettale
Investigators
- Principal Investigator: Donato F Altomare, MD, University of Bari, Italy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SICCR 10/2006