Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
NCT ID: NCT00723047
Last Updated: 2011-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
77 participants
INTERVENTIONAL
2003-11-30
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
Fibrin glue injection in fistula
Interventions
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Fibrin glue injection in fistula
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Nycomed
INDUSTRY
Société Nationale Française de Gastroentérologie
OTHER
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
OTHER
Responsible Party
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Locations
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Sart Tilman University Hospital
Liège, , Belgium
Beaujon Hospital
Clichy, , France
Louis Mourrier Hospital
Colombes, , France
CHRU Lille
Lille, , France
Marseille North Hospital
Marseille, , France
Nice University Hospital
Nice, , France
Hopital St Louis
Paris, , France
Lariboisiere Hospital
Paris, , France
Georges Pompidou European Hospital
Paris, , France
Bichat Hospital
Paris, , France
Lyon Sud University Hospital
Pierre-Bénite, , France
Pontchaillou University Hospital
Rennes, , France
Rouen University Hospital
Rouen, , France
Trousseau University Hospital
Tours, , France
Countries
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References
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Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525.
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. doi: 10.1053/gast.2002.32362.
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. doi: 10.7326/0003-4819-135-10-200111200-00011.
Bernstein LH, Frank MS, Brandt LJ, Boley SJ. Healing of perineal Crohn's disease with metronidazole. Gastroenterology. 1980 Aug;79(2):357-65.
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. doi: 10.1056/NEJM198005013021801.
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. doi: 10.7326/0003-4819-123-2-199507150-00009.
Grimaud JC, Munoz-Bongrand N, Siproudhis L, Abramowitz L, Senejoux A, Vitton V, Gambiez L, Flourie B, Hebuterne X, Louis E, Coffin B, De Parades V, Savoye G, Soule JC, Bouhnik Y, Colombel JF, Contou JF, Francois Y, Mary JY, Lemann M; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif. Fibrin glue is effective healing perianal fistulas in patients with Crohn's disease. Gastroenterology. 2010 Jun;138(7):2275-81, 2281.e1. doi: 10.1053/j.gastro.2010.02.013. Epub 2010 Feb 20.
Related Links
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Related Info
Other Identifiers
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GETAID 2003-1
Identifier Type: -
Identifier Source: org_study_id
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