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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fibrin glue injection in fistula
Sponsored by
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Patients, CD complicated, least, One perianal fistula, Draining, 2 months duration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sart Tilman University Hospital
  • Beaujon Hospital
  • Louis Mourrier Hospital
  • CHRU Lille
  • Marseille North Hospital
  • Nice University Hospital
  • Hopital St Louis
  • Lariboisiere Hospital
  • Georges Pompidou European Hospital
  • Bichat Hospital
  • Lyon Sud University Hospital
  • Pontchaillou University Hospital
  • Rouen University Hospital
  • Trousseau University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Early Clinical Remission
Occurrence of perianal abcess

Full Information

First Posted
July 25, 2008
Last Updated
September 2, 2011
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborators
Nycomed, Société Nationale Française de Gastroentérologie
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1. Study Identification

Unique Protocol Identification Number
NCT00723047
Brief Title
Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
Acronym
Fibrin glue
Official Title
Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborators
Nycomed, Société Nationale Française de Gastroentérologie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Patients, CD complicated, least, One perianal fistula, Draining, 2 months duration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Fibrin glue injection in fistula
Primary Outcome Measure Information:
Title
Clinical Remission
Description
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.
Time Frame
8 weeks after inclusion
Secondary Outcome Measure Information:
Title
Early Clinical Remission
Time Frame
4 weeks after Inclusion
Title
Occurrence of perianal abcess
Time Frame
During whole study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sart Tilman University Hospital
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Beaujon Hospital
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Louis Mourrier Hospital
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
CHRU Lille
City
Lille
Country
France
Facility Name
Marseille North Hospital
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Nice University Hospital
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital St Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Lariboisiere Hospital
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Georges Pompidou European Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Bichat Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Lyon Sud University Hospital
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Pontchaillou University Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Trousseau University Hospital
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
7429313
Citation
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.
Results Reference
background
PubMed Identifier
11910338
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. doi: 10.1053/gast.2002.32362.
Results Reference
background
PubMed Identifier
11712881
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. doi: 10.7326/0003-4819-135-10-200111200-00011.
Results Reference
background
PubMed Identifier
7399243
Citation
Bernstein LH, Frank MS, Brandt LJ, Boley SJ. Healing of perineal Crohn's disease with metronidazole. Gastroenterology. 1980 Aug;79(2):357-65.
Results Reference
background
PubMed Identifier
6102739
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. doi: 10.1056/NEJM198005013021801.
Results Reference
background
PubMed Identifier
7778826
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. doi: 10.7326/0003-4819-123-2-199507150-00009.
Results Reference
background
PubMed Identifier
20178792
Citation
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.
Results Reference
derived
Links:
URL
http://www.getaid.org
Description
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Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial

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