Clinical trial NCT00929630: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anal Fistulas
Keywords: fibrin glue
transsphincteric anal fistulas
seton
incontinence
prospective randomised trial
Lead sponsor: Societa Italiana di Chirurgia ColoRettale
Sponsor class: NETWORK
First posted: 2009-06-29
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Fecal continence and in-hospital stay
timeFrame: 12 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Dept of Emergency and Organ transplantation - University of Bari
Study officials:
affiliation: University of Bari
name: Donato F Altomare, MD
role: PRINCIPAL_INVESTIGATOR
References: