DRainage versus sEAlant in prospective, Monocentric, double blinded randomized trial to evaluate the effect of fibrin glue in surgical repair of incisional hernias (DREAM-trial) - DREAM

Phase 1

• Conditions: Open incisional hernia mesh repair

• Registration Number: EUCTR2008-004113-96-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-29
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

- written informed consent from the patient.
- incisional hernia larger than 5cm in diameter requiring elective surgical repair.
- the diameter will be estimated pre-operatively and confirmed intra-operatively. The intra-operative measure be the definite value.
- only primary incisional hernias will be considered.
- A retromuscular preperitoneal mesh repair should be the intention to repair the hernia.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- no written informed consent
- ‘hostile’ abdomen
- emergency surgery (incarcerated hernia)
- parastomal hernia
- incisional hernia outside the midline
- recurrent incisional hernia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified