Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair

Study Overview
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Brief Summary
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Hernia of the abdominal wall occur frequently after various surgical procedures of the abdomen and are increasingly performed by laparoscopic means. Different mesh fixation techniques are applied, but the influence of mesh fixation on shrinkage is not known in human patients. Therefore, mesh shrinkage was assessed using two different techniques for fixation.

Detailed Description
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Ventral hernia repair is increasingly performed by laparoscopic means. While mesh ingrowth and shrink-age has been analysed in the experimental setting, there is scarce data available in humans. In addition, different mesh fixation techniques are applied, but the influence of mesh fixation on shrinkage is not known in human patients. Mesh shrinkage is assessed using two different techniques for fixation. Blinded randomized trial using a Parietene composite mesh for laparoscopic ventral hernia repair. Patients with ventral hernias of no larger than 8 cm were assigned to either mesh fixation using transfacial nonabsorbable sutures or titan tacks. Primary endpoint was mesh migration, secondary endpoints were mesh shrinkage, surgical morbidity and pain.

Official Title
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Mesh Shrinkage Following Transfacial Suturing Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair: a Prospective, Randomised Blinded Study

Conditions
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Ventral Hernia, Pain

Intervention / Treatment
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* Procedure: mesh fixation by transfacial sutures
* Procedure: mesh fixation by staples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with incisional hernia smaller than 8cm in diameter obtained informed consent Exclusion Criteria: Pregnancy Residual intraperitoneal mesh contaminated abdominal cavity longterm use of corticosteroids and other immunosuppressive agents bodymass index > 45 general contradictions for laparoscopy

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>transfacial sutures | Procedure: mesh fixation by transfacial sutures<br>* mesh fixation by transfacial sutures<br>|
| Other: B<br>staples | Procedure: mesh fixation by staples<br>* mesh fixation by staples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mesh shrinkage |  | perioperative, 6 weeks, 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mesh dislocation |  | perioperative, 6 weeks postoperative,6 months postoperative | 
| pain |  | perioperative, 6 weeks postoperative,6 months, 12 moths postoperative | 
| recurrence |  | perioperative, 6 weeks postoperative,6 months, 12 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventral hernia, laparoscopy, mesh, recurrence