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

Not Applicable

• Conditions: Incisional Hernia
• Interventions: Procedure: prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturing

• Registration Number: NCT05359510
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-04-25
• Study Start: 2022-04-26
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-04
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-26
• Primary Completion: 2022-09-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient with various abdominal incisions to be operated	prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturing	patients with various abdominal incisions for closure either by primary suturing or by mesh

Primary Outcome Measures

Name	Time	Method
early wound complications	1 month	wound infection (with or without removal of the mesh) ,wound necrosis , wound hematoma
late wound complications	1 month	post operative incisional hernia, wound infection (with or without removal of the mesh) wound necrosis wound hematoma.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt