LVHR Multicenter Study

Study Overview
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Brief Summary
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The study aims to prove differences or equalities in outcome for patients operated with laparoscopic ventral hernia repair with different methods of fixation of mesh and with or without approximation of defect prior to meshfixation.

Detailed Description
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Patients are randomized to 4 groups: non-absorbable suture fixation and hernia approximation, double crown mesh fixation with titanium spiral tacks with hernia approximation and the same fixations without hernia approximation. Primary endpoint is recurrence. Secondary endpoints are operating time, adhesion score, mode of entering abdominal cavity, time to recovery, pain durance, seroma formation, aesthetic result (protrusion), organ traumatization infection. Endpoints are correlated to hernia size, body mass index, previous recurrence, age, concurrent illness. Patients are followed 3 years after operation with clinical examination. 300 patients are planned included in primary study. A subgroup of organ transplanted patients is evaluated in a separate study with identical criteria for inclusion.

Official Title
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Randomized Controlled National Multicenter Study for Evaluation of Two Different Ways of Fixation of Mesh-implants and Differences With or Without Approximation of Herniadefects at Laparoscopic Operation for Incisional and Ventral Hernia

Conditions
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Ventral and Ventral Insicional Hernia

Intervention / Treatment
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* Procedure: Laparoscopic ventral hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: secondary or primary ventral hernia Exclusion Criteria: Loss of domain, Giant hernia with need of abdominal plastic operation, ASA score above 3

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: a<br>a: suture anchoring + tackers and approximation of defect | Procedure: Laparoscopic ventral hernia repair<br> <br> |
| Active Comparator: b<br>b: suture anchoring + tackers without approximation of defect | Procedure: Laparoscopic ventral hernia repair<br> <br> |
| Active Comparator: c<br>c: only tacker fixation and approximation of defect | Procedure: Laparoscopic ventral hernia repair<br> <br> |
| Active Comparator: d<br>d: only tacker fixation without approximation of defect | Procedure: Laparoscopic ventral hernia repair<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time |  | 30-180 min | 
| Adhesion score |  |  | 
| Mode of entering abdominal cavity |  |  | 
| Pain durance |  | 8 weeks | 
| Seroma formation |  |  | 
| Aesthetic result (protrusion) |  | 3 years | 
| Infection |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, ventral, hernia, repair, surgery