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

Crohn's Disease Clinical Trial

— Fibrin glue  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723047
• Other study ID #: GETAID 2003-1
• Status: Completed
• Phase: Phase 3
• First received: July 25, 2008
• Last updated: September 2, 2011
• Start date: November 2003
• Est. completion date: August 2006

Study information

• Verified date: September 2011
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: August 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Procedure:
• Fibrin glue injection in fistula

Locations

Country	Name	City	State
Belgium	Sart Tilman University Hospital	Liege
France	Beaujon Hospital	Clichy
France	Louis Mourrier Hospital	Colombes
France	CHRU Lille	Lille
France	Marseille North Hospital	Marseille
France	Nice University Hospital	Nice
France	Bichat Hospital	Paris
France	Georges Pompidou European Hospital	Paris
France	Hopital St Louis	Paris
France	Lariboisiere Hospital	Paris
France	Lyon Sud University Hospital	Pierre Benite
France	Pontchaillou University Hospital	Rennes
France	Rouen University Hospital	Rouen
France	Trousseau University Hospital	Tours

Sponsors (3)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	Nycomed, Société Nationale Française de Gastroentérologie

Countries where clinical trial is conducted

Belgium,  France, 

References & Publications (6)

Bernstein LH, Frank MS, Brandt LJ, Boley SJ. Healing of perineal Crohn's disease with metronidazole. Gastroenterology. 1980 Aug;79(2):357-65. — View Citation

Hellers G, Bergstrand O, Ewerth S, Holmström B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. — View Citation

Pearson DC, May GR, Fick GH, Sutherland LR. Azathioprine and 6-mercaptopurine in Crohn disease. A meta-analysis. Ann Intern Med. 1995 Jul 15;123(2):132-42. — View Citation

Present DH, Korelitz BI, Wisch N, Glass JL, Sachar DB, Pasternack BS. Treatment of Crohn's disease with 6-mercaptopurine. A long-term, randomized, double-blind study. N Engl J Med. 1980 May 1;302(18):981-7. — View Citation

Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. — View Citation

Schwartz DA, Pemberton JH, Sandborn WJ. Diagnosis and treatment of perianal fistulas in Crohn disease. Ann Intern Med. 2001 Nov 20;135(10):906-18. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Remission	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.	8 weeks after inclusion	No
Secondary	Early Clinical Remission		4 weeks after Inclusion	No
Secondary	Occurrence of perianal abcess		During whole study	No

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