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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00775034
First received: October 16, 2008
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Incisional Hernia
Drug: Tisseel®
Procedure: Drainage
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Hospital stay [ Time Frame: At time of discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative drainage volume [ Time Frame: Day 0,1, 2, 3 ? and at day of removal ] [ Designated as safety issue: No ]
  • Perioperative morbidity rate [ Time Frame: At time of discharge ] [ Designated as safety issue: Yes ]
  • Pain measured using VAS [ Time Frame: Daily till discharge and after 3 weeks post-surgery ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Recurrence [ Time Frame: At one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Study group (Tisseel®)
Drug: Tisseel®
Mesh repair for open incisional hernia repair with fibrin sealant
2
Control group
Procedure: Drainage
Mesh repair for open incisional hernia repair with drainage

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775034

Contacts
Contact: Frederik Berrevoet, MD Frederik.berrevoet@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Frederik Berrevoet, MD         
UZ gasthuisberg Leuven Recruiting
Leuven, Belgium
Principal Investigator: Prof. Dr. M. Miserez         
Sponsors and Collaborators
University Hospital, Ghent
Baxter Healthcare Corporation
Investigators
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00775034     History of Changes
Other Study ID Numbers: 2008/433
Study First Received: October 16, 2008
Last Updated: January 31, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 22, 2014