Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall Hernias

Study Overview
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Brief Summary
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Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter

Detailed Description
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Many techniques of ventral hernias repair have been reported. It is shown that open mesh hernia repairs have low recurrence and low complication rates then suture repair. But for hernias less than 3 cm some surgeons defend the treatment by suture. The main variable of interest is the location of mesh placement compared to suture repair. The investigator will compare in a prospective randomized clinical trial three techniques of abdominal wall hernia repair: preperitoneal polyester mesh, retromuscular polyester mesh and suture for hernias less than 3 cm. All patients underwent general anesthesia. The investigators used Polyester-based mesh because it has shown minimal shrinkage and excellent tissue ingrowth in animal models. Operative notes were physician-abstracted and the presence, type, and location of mesh prosthesis was recorded. Independent variables of interest were patient-level demographics (age and sex), facility where hernia repair occurred, year of hernia repair, preoperative comorbid conditions, history of prior repair, and intraoperative variables. The results compared postoperative pain was evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit, operating time evaluated as skin-to-skin time, drain management and both of early and late complications including seroma and hematoma formation, wound infection, fistula formation and recurrence rates.

Official Title
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Randomized Clinical Trial Comparing Open Preperitoneal Mesh, Retromuscular Mesh and Suture Repair for Abdominal Wall Hernias Less Than 3 cm Diameter

Conditions
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Ventral Hernia, Ventral Incisional Hernia, Umbilical Hernia

Intervention / Treatment
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* Procedure: Ventral hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vebtral hernia or post incisional hernia diameter < 3 cm Male or female aged between 18 and 90 year-old Elective surgery for ventral hernia Exclusion Criteria: Any contraindication to the prosthetic treatment. Any hernia or incisional hernia with a collar strictly greater than 3 cm. Previous hernia mesh repaired contraindication for general anaesthesia Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: Preperitoneal mesh repair<br>Ventral hernia repair using polyester preperitoneal mesh repair | Procedure: Ventral hernia repair<br>* Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.<br>* Other names: suture hernia repair;|
| Experimental: Retromuscular mesh repair<br>Ventral hernia repair using polyester retromuscular mesh repair | Procedure: Ventral hernia repair<br>* Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.<br>* Other names: suture hernia repair;|
| Experimental: Suture repair<br>Ventral hernia repair using suture repair | Procedure: Ventral hernia repair<br>* Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.<br>* Other names: suture hernia repair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rates | Late complications of ventral hernia repair | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time | operating time evaluated as skin-to-skin time | 15 to 90 minutes | 
| Early complication | Early complicaion including seroma and hematoma formation, wound infection and fistula | 30 days | 
| Postoperative pain | Postoperative pain evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit | 6, 12 and 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventral hernia, Open mesh repair, Polyester mesh, Preperitoneal, Retromuscular