Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
Fibrin glue
1 other identifier
interventional
77
2 countries
14
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2003
Typical duration for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 28, 2008
CompletedSeptember 5, 2011
September 1, 2011
2.6 years
July 25, 2008
September 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Early Clinical Remission
4 weeks after Inclusion
Occurrence of perianal abcess
During whole study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Sart Tilman University Hospital
Liège, 4000, Belgium
Beaujon Hospital
Clichy, 92110, France
Louis Mourrier Hospital
Colombes, 92700, France
CHRU Lille
Lille, France
Marseille North Hospital
Marseille, 13915, France
Nice University Hospital
Nice, 06202, France
Hopital St Louis
Paris, 75010, France
Lariboisiere Hospital
Paris, 75010, France
Georges Pompidou European Hospital
Paris, 75015, France
Bichat Hospital
Paris, 75018, France
Lyon Sud University Hospital
Pierre-Bénite, 69495, France
Pontchaillou University Hospital
Rennes, 35033, France
Rouen University Hospital
Rouen, 76031, France
Trousseau University Hospital
Tours, 37044, France
Related Publications (7)
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.
PMID: 7429313BACKGROUNDSchwartz 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.
PMID: 11910338BACKGROUNDSchwartz 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.
PMID: 11712881BACKGROUNDBernstein LH, Frank MS, Brandt LJ, Boley SJ. Healing of perineal Crohn's disease with metronidazole. Gastroenterology. 1980 Aug;79(2):357-65.
PMID: 7399243BACKGROUNDPresent 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.
PMID: 6102739BACKGROUNDPearson 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.
PMID: 7778826BACKGROUNDGrimaud 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.
PMID: 20178792DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 28, 2008
Study Start
November 1, 2003
Primary Completion
June 1, 2006
Study Completion
August 1, 2006
Last Updated
September 5, 2011
Record last verified: 2011-09