Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.

NCT ID: NCT00252369

Last Updated: 2009-04-24

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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This study is aimed to assess the hypothesis that instillation of fibrin glue with the induction of local conditions using Infliximab, may be useful in the treatment of perianal Crohn's disease.

Detailed Description

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Patients with perianal fistulae of Crohn's disease will be prospectively enrolled and receive 3 doses of Infliximab. If reduction of fistula associated discharge of at least 50% will be recorded, commercially available fibrin glue will be instilled into the fistula tract using standard surgical techniques. The patients will be followed for 6 months for fistula healing and complications.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Infliximab

Intervention Type DRUG

Instillation of fibrin glue

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Perianal fistula of Crohn's dis

Exclusion Criteria

* More then 2 fistulae perianal sepsis known contraindication to infliximab or glue
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Oded Zmora, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Assaf Harofe Medical Center

Zrifin, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-05-3762-OZ-CTIL

Identifier Type: -

Identifier Source: org_study_id

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