Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias

Study Overview
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Brief Summary
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The purpose of this study is to: compare the long term results of mesh versus suture repair in treatment of abdominal wall defects; find the optimal location of implanted prosthesis, comparing the two most useful position of mesh in abdominal wall hernia surgery.

Detailed Description
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To determine difference of operation time, applied materials of hernia operations; clinical complications, postoperative pain, hernia recurrence, recovery and normal activity time after surgery.

Official Title
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Results of Open Mesh Versus Suture Repair in Treatment of Abdominal Wall (Multicentric, Prospective, Randomised, Internet-based, Clinical Trial)

Conditions
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Abdominal Hernia

Intervention / Treatment
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* Procedure: abdominal wall reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: During the two-year randomization period at the joined centres all patients were included who were admitted with abdominal wall or umbilical hernia and who suited the requirements. All the patients with primer or first recurrence of postoperative abdominal or primer or first recurrence of umbilical hernia were randomized into this study. For involvement into the study good patient compliance, signed consent form, normal local circumstances were needed. Exclusion Criteria: Ages fewer than 18 or above 70 years Hernia orifice under 5 cm2. Planned or accidental intraoperative opening of any bowel. Unstable parameters of circulation, uncontrollable diabetic or autoimmune disease. Severe renal or hepatic failure Advanced stage of tumours or currently treated malignancies. Inflamed or muddy content of hernia sac. If the patient did not signed the consent form.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: small hernias - suture repair<br> | Procedure: abdominal wall reconstruction<br>* suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate<br>|
| Active Comparator: small hernias - mesh repair<br> | Procedure: abdominal wall reconstruction<br>* suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate<br>|
| Active Comparator: large hernias - sublay mesh<br> | Procedure: abdominal wall reconstruction<br>* suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate<br>|
| Active Comparator: large hernias - onlay mesh<br> | Procedure: abdominal wall reconstruction<br>* suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate after hernia surgery |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic pain after hernia surgery |  | more one year | 
| complications after hernia surgery |  | 0-5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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position of the mesh, recurrence rate, surgical procedure, long time outcome