Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

Phase 4CompletedNCT00775034

University Hospital, Ghent57 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Incisional Hernia

Interventions

Tisseel®DRUG

Mesh repair for open incisional hernia repair with fibrin sealant

DrainagePROCEDURE

Mesh repair for open incisional hernia repair with drainage

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospital Ghent

Ghent, Belgium

UZ gasthuisberg Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Hospital stay

Time frame: At time of discharge

Secondary Outcomes

Postoperative drainage volume

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

Perioperative morbidity rate

Time frame: At time of discharge

Pain measured using VAS

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

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

Recurrence

Time frame: At one year

Data from ClinicalTrials.gov

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