The Use of Different Types of Mesh for Prevention of Incisional Hernia Versus Primary Abdominal Suturing

Study Overview
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Brief Summary
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The use of different types of mesh at different sites in prevention of incisional hernia after various abdominal incision versus primary abdominal suturing.

Detailed Description
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The burden of incisional hernia after abdominal exploration has raised the question if a prophylactic mesh placement during abdominal wall closure is of benefit. The reported rate of incisional hernia after abdominal incisions varies from 4.2% up to a calculated risk of 73%. The impact on quality of life and annual health care costs has motivated various groups to research ways to decrease the rate of incisional hernia by optimizing the technique of abdominal wall closure. One of the crucial risk factors of the genesis of incisional hernias is the malfunction of collagen synthesis. Other main risk factors are found to be obesity, steroid therapy, malnutrition, nicotine abuse, and other connective tissue diseases. Since German physician Theodor Billroth's first suggested use of prosthetic material to close the hernia defect in 1890, continued interest lead to the development of a variety of surgical meshes and techniques for suture and mesh reinforcement to prevent incisional hernia . Overtime, RCTs have demonstrated the effectiveness of the use of prophylactic mesh in the prevention of incisional hernia. While surgeons world over use different techniques of positioning mesh in the prophylactic mesh repair (PMR) such as the Onlay, Sublay and Intraperitoneal positions, which can be associated with a high incidence of complications such as the postoperative seroma.

Official Title
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The Use of Different Types of Mesh at Different Sites in the Prevention of Incisional Hernia After Various Abdominal Incision Versus Primary Abdominal Suturing.

Conditions
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Incisional Hernia

Intervention / Treatment
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* Procedure: prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent patient age: ≥ 18 years patients undergoing elective or urgent open abdominal surgical procedure regardless of benign or malignant disease Exclusion Criteria: age <18 years navel site infection pregnancy expected survival <12 month previous intra abdominal mesh placement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient with various abdominal incisions to be operated<br>patients with various abdominal incisions for closure either by primary suturing or by mesh | Procedure: prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturing<br>* before closure of the abdominal layers prophylactic mesh will be used for prevention of incisional hernia. another patient with abdominal incision , primary closure of abdominal layer will occur.<br>* Other names: closure of various abdominal incision by different types of prophylactic mesh at different sites for prevention of incisional hernia versus primary abdominal closure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early wound complications | wound infection (with or without removal of the mesh) ,wound necrosis , wound hematoma | 1 month | 
| late wound complications | post operative incisional hernia, wound infection (with or without removal of the mesh) wound necrosis wound hematoma. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate | major bleeding bowel injury | intraoperative complications will be recorded immediately after finishing the operation | 
| incidence of incisional hernia | the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups. | 12 month |