Seton or Glue for Trans-sphincteric Anal Fistulas
Primary Purpose
Anal Fistulas
Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
transsphincteric Seton positioning
glue (Tissucol) treatment
Fistula closing with biological glue
Seton positioning into the fistula tract
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fistulas focused on measuring fibrin glue, transsphincteric anal fistulas, seton, incontinence, prospective randomised trial
Eligibility 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.
Sites / Locations
- Dept of Emergency and Organ transplantation - University of Bari
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
glue (Tissucol ) treatment
Seton treatment
Arm Description
patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before
patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before
Outcomes
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.
Secondary Outcome Measures
Fecal continence and in-hospital stay
Full Information
NCT ID
NCT00929630
First Posted
March 30, 2009
Last Updated
September 15, 2009
Sponsor
Societa Italiana di Chirurgia ColoRettale
1. Study Identification
Unique Protocol Identification Number
NCT00929630
Brief Title
Seton or Glue for Trans-sphincteric Anal Fistulas
Official Title
Seton or Glue for Trans-sphincteric Anal Fistulas. A Prospective Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Terminated
Why Stopped
Evident advantages of one treatment (seton) over the other (Tissucol Glue)
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Societa Italiana di Chirurgia ColoRettale
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistulas
Keywords
fibrin glue, transsphincteric anal fistulas, seton, incontinence, prospective randomised trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
glue (Tissucol ) treatment
Arm Type
Experimental
Arm Description
patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before
Arm Title
Seton treatment
Arm Type
Active Comparator
Arm Description
patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before
Intervention Type
Procedure
Intervention Name(s)
transsphincteric Seton positioning
Other Intervention Name(s)
seton treatment of the fistula
Intervention Description
A cutting seton is applied into the fistula tract
Intervention Type
Procedure
Intervention Name(s)
glue (Tissucol) treatment
Other Intervention Name(s)
fibrin glue treatment of perianal fistulas
Intervention Description
After preparation of the fistula, a quantity of biological glue (Tissucol) is injected into the fistula tract
Intervention Type
Procedure
Intervention Name(s)
Fistula closing with biological glue
Other Intervention Name(s)
fibrin glue treatment of perianal fistulas
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Seton positioning into the fistula tract
Other Intervention Name(s)
loose seton, cutting seton for anal fistulas
Intervention Description
Under spinal anesthesia a Seton is positioned into the fistula tract.
Primary Outcome Measure Information:
Title
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Fecal continence and in-hospital stay
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donato F Altomare, MD
Organizational Affiliation
University of Bari, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Emergency and Organ transplantation - University of Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Seton or Glue for Trans-sphincteric Anal Fistulas
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