Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

NCT ID: NCT00775034

Last Updated: 2018-06-26

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-27

Study Completion Date

2018-05-24

Brief Summary

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Mesh repair for open incisional hernia repair with fibrin sealant or with drainage

Detailed Description

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Conditions

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Incisional Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Study group (Tisseel®)

Group Type EXPERIMENTAL

Tisseel®

Intervention Type DRUG

Mesh repair for open incisional hernia repair with fibrin sealant

2

Control group

Group Type OTHER

Drainage

Intervention Type PROCEDURE

Mesh repair for open incisional hernia repair with drainage

Interventions

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Tisseel®

Mesh repair for open incisional hernia repair with fibrin sealant

Intervention Type DRUG

Drainage

Mesh repair for open incisional hernia repair with drainage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients with a large incisional hernia \>5cm diameter that needs elective repair with mesh augmentation

Exclusion Criteria

* no written informed consent
* 'hostile' abdomen
* emergency surgery (incarcerated hernia)
* parastomal hernia
* incisional hernia outside the midline
* recurrent incisional hernia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederik Berrevoet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

UZ gasthuisberg Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2008/433

Identifier Type: -

Identifier Source: org_study_id

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