NCT00929630

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 29, 2009

Completed
Last Updated

September 16, 2009

Status Verified

September 1, 2009

Enrollment Period

1.3 years

First QC Date

March 30, 2009

Last Update Submit

September 15, 2009

Conditions

Anal Fistulas

Keywords

fibrin gluetranssphincteric anal fistulassetonincontinenceprospective randomised trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Fecal continence and in-hospital stay

    12 months

Study Arms (2)

glue (Tissucol ) treatment

EXPERIMENTAL

patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before

Procedure: glue (Tissucol) treatmentProcedure: Fistula closing with biological glue

Seton treatment

ACTIVE COMPARATOR

patients with transsphincteric anal fistulas of cryptoglandular origin never operated on before

Procedure: transsphincteric Seton positioningProcedure: Seton positioning into the fistula tract

Interventions

transsphincteric Seton positioningPROCEDURE

A cutting seton is applied into the fistula tract

Also known as: seton treatment of the fistula
Seton treatment
glue (Tissucol) treatmentPROCEDURE

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

Also known as: fibrin glue treatment of perianal fistulas
glue (Tissucol ) treatment
Fistula closing with biological gluePROCEDURE

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

Also known as: fibrin glue treatment of perianal fistulas
glue (Tissucol ) treatment
Seton positioning into the fistula tractPROCEDURE

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

Also known as: loose seton, cutting seton for anal fistulas
Seton treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medium or high trans-sphincteric fistulas of cryptoglandular origin, no previous treatments

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Emergency and Organ transplantation - University of Bari

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Rectal Fistula

Interventions

AdhesivesFibrin Tissue AdhesiveTherapeutics

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and AgricultureFibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Donato F Altomare, MD

    University of Bari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

March 30, 2009

First Posted

June 29, 2009

Study Start

January 1, 2006

Primary Completion

May 1, 2007

Study Completion

June 1, 2007

Last Updated

September 16, 2009

Record last verified: 2009-09

Locations

IT(1)