Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00723047

Acronym

Fibrin glue

Enrollment

Registered

2008-07-28

Start date

2003-11-30

Completion date

2006-08-31

Last updated

2011-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Patients, CD complicated, least, One perianal fistula, Draining, 2 months duration

Brief summary

This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège, Belgium approved the protocol for each participating centers. Recruitment took place at 12 sites (11 in France and 1 in Belgium)

Interventions

PROCEDUREFibrin glue injection in fistula

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* at least 18 years old * CD confirmed by endoscopy and histology. * CDAI should be 250 or less * at least one perianal fistula (between anus or low rectum and perineum, vulva or vagina) draining for more than 2 months duration

Exclusion criteria

* treatment with an anti-TNF agent or with ciclosporin or tacrolimus within the last 3 months * presence of a perianal abscess (\>1cm) assessed by magnetic resonance imaging (MRI) or endo-anal ultrasonography performed within the last month, * presence of anal or rectal stenosis, * surgery during the previous month (except seton removal), * previous fibrin glue injection, * pregnancy.

Design outcomes

Primary

Measure	Time frame	Description
Clinical Remission	8 weeks after inclusion	Clinical remission was defined as * the absence of any draining by fistula openings occurring spontaneously or after gentle finger compression , * the absence of perianal pain * and the absence of perianal abscess.

Secondary

Measure	Time frame
Early Clinical Remission	4 weeks after Inclusion
Occurrence of perianal abcess	During whole study

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026