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Completed

NCT Number: NCT00723047

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

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)

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sart Tilman University Hospital, Liège, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibrin glue injection in fistula

Procedure

Primary outcomes

  1. Clinical Remission

    Time frame: 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 outcomes

  1. Early Clinical Remission

    Time frame: 4 weeks after Inclusion

  2. Occurrence of perianal abcess

    Time frame: During whole study

Sponsors and collaborators

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Other

Collaborators

  • Nycomed
  • Société Nationale Française de Gastroentérologie

Registry information

Acronym: Fibrin glue

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Jul 28, 2008
Registry last updated
Sep 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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