Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh

Study Overview
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Brief Summary
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The intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the gold-standard for the repair of incisional hernia. However no studies have convincingly proven that this approach is better than the on-lay repair. The authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.

Official Title
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Randomized Study of Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh Versus On-lay Mesh Repair

Conditions
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Incisional Hernia

Intervention / Treatment
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* Device: Implant of a prosthetic mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2) First repair Older than 35 years of age and younger than 75 years of age Both genders Any BMI Only upper abdominal midline incisional hernias (supraumbilical) Patients submitted only to elective repair Exclusion Criteria: Recurrent incisional hernia Emergency surgery Hernias with a diameter higher than 5 cm or more than 25 cm2 of area Lower midline abdominal incisional hernias Other hernias rather than midline incisional hernias Non-incisional hernias

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Intraperitoneal repair<br>Patients with incisional hernia, 5 cm in diameter or with an area of 25 cm2, submitted to elective surgery | Device: Implant of a prosthetic mesh<br>* A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study<br>|
| Active Comparator: 2. On-Lay repair<br>Patients with incisional hernia, with a diameter of 5 cm or an area of 25 cm2, submitted to elective surgery | Device: Implant of a prosthetic mesh<br>* A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term recurrence |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term complications |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incisional hernia, Intraperitoneal mesh repair, On-lay repair, Prosthetic mesh, First repair (no recurrent hernia will be included), Recurrence, Complications