The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair

Study Overview
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Brief Summary
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A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in laparoscopic ventral hernia repair.

Official Title
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The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair.

Conditions
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Ventral Hernia

Intervention / Treatment
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* Procedure: Closure of hernia defect.
* Procedure: No closure of the hernia defect.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent from the patient or his/her legal representative Ventral or incisional hernia requiring elective surgical repair Diameter between 2 and 5cm in width Midline and flank hernias are eligible Exclusion Criteria: No written informed consent 'Hostile' abdomen, open abdomen treatment Contraindication to pneumoperitoneum Emergency surgery (incarcerated hernia) Parastomal hernia Subxiphoidal hernia Subcostal hernia Suprapubic hernia Clean-contaminated or contaminated field Hernia diameter >5cm in width Pregnancy Non-compliance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Closure<br> | Procedure: Closure of hernia defect.<br>* Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).<br>|
| Sham Comparator: Non-Closure<br> | Procedure: No closure of the hernia defect.<br>* Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroma formation after 4 weeks. | The seroma formation is checked by clinical evaluation. | 4 weeks after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, discomfort and esthetic evaluation after 4 weeks. | Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale. | 4 weeks after surgery. | 
| Pain, discomfort and esthetic evaluation after 1 year. | Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale. | 1 year after surgery. | 
| Pain, discomfort and esthetic evaluation after 2 years. | Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale. | 2 years after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventral hernia