Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

Phase 4

Completed

• Conditions: Incisional Hernia
• Interventions: Drug: Tisseel®; Procedure: Drainage

• Registration Number: NCT00775034
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Study Start: 2010-01-27
• Primary Completion: 2014-10-14
• Study Completion: 2018-05-24
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-22
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Tisseel®	Study group (Tisseel®)
2	Drainage	Control group

Primary Outcome Measures

Name	Time	Method
Hospital stay	At time of discharge

Secondary Outcome Measures

Name	Time	Method
Postoperative drainage volume	Day 0,1, 2, 3 ? and at day of removal
Perioperative morbidity rate	At time of discharge
Pain measured using VAS	Daily till discharge and after 3 weeks post-surgery
Quality of life by SF-36 questionnaire	Preoperatively, at time of discharge, 2 weeks after discharge, 6 weeks after discharge and 1 year post surgery
Recurrence	At one year

Trial Locations

Locations (2)

University Hospital Ghent; 🇧🇪 Ghent, Belgium

UZ gasthuisberg Leuven; 🇧🇪 Leuven, Belgium