Skip to main content
OpenTrials
Completed

NCT Number: NCT00775034

Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Incisional Hernia Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Ghent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tisseel®

Drug

Mesh repair for open incisional hernia repair with fibrin sealant

Drainage

Procedure

Mesh repair for open incisional hernia repair with drainage

Primary outcomes

  1. Hospital stay

    Time frame: At time of discharge

Secondary outcomes

  1. Postoperative drainage volume

    Time frame: Day 0,1, 2, 3 ? and at day of removal

  2. Perioperative morbidity rate

    Time frame: At time of discharge

  3. Pain measured using VAS

    Time frame: Daily till discharge and after 3 weeks post-surgery

  4. 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

  5. Recurrence

    Time frame: At one year

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Acronym: DREAM

Important dates

Study start
2010
Primary completion
2014
Study completion
2018
First posted
Oct 17, 2008
Registry last updated
Jun 26, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.