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Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair (DREAM)

Primary Purpose

Incisional Hernia

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Tisseel®
Drainage
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incisional Hernia

Eligibility Criteria

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

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

Sites / Locations

  • University Hospital Ghent
  • UZ gasthuisberg Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Study group (Tisseel®)

Control group

Outcomes

Primary Outcome Measures

Hospital stay

Secondary Outcome Measures

Postoperative drainage volume
Perioperative morbidity rate
Pain measured using VAS
Quality of life by SF-36 questionnaire
Recurrence

Full Information

First Posted
October 16, 2008
Last Updated
June 22, 2018
Sponsor
University Hospital, Ghent
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00775034
Brief Title
Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair
Acronym
DREAM
Official Title
Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 27, 2010 (Actual)
Primary Completion Date
October 14, 2014 (Actual)
Study Completion Date
May 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Study group (Tisseel®)
Arm Title
2
Arm Type
Other
Arm Description
Control group
Intervention Type
Drug
Intervention Name(s)
Tisseel®
Intervention Description
Mesh repair for open incisional hernia repair with fibrin sealant
Intervention Type
Procedure
Intervention Name(s)
Drainage
Intervention Description
Mesh repair for open incisional hernia repair with drainage
Primary Outcome Measure Information:
Title
Hospital stay
Time Frame
At time of discharge
Secondary Outcome Measure Information:
Title
Postoperative drainage volume
Time Frame
Day 0,1, 2, 3 ? and at day of removal
Title
Perioperative morbidity rate
Time Frame
At time of discharge
Title
Pain measured using VAS
Time Frame
Daily till discharge and after 3 weeks post-surgery
Title
Quality of life by SF-36 questionnaire
Time Frame
Preoperatively, at time of discharge, 2 weeks after discharge, 6 weeks after discharge and 1 year post surgery
Title
Recurrence
Time Frame
At one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ gasthuisberg Leuven
City
Leuven
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

Learn more about this trial

Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

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