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

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

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

Study Overview

• Status: Recruiting
• Conditions: Incisional Hernia
• Intervention / Treatment: Procedure: prophylactic mesh repair at different sites for 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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: kerolos samer, Reside doctor; Phone Number: +201277838435; Email: kerolos.samer1295@gmail.com
• Study Contact Backup: Name: Ahmed Soliman, prof ofsurgery; Phone Number: 01091672661; Email: ahmedmmsoliman@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: patient with various abdominal incisions to be operated; 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; 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.; 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?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Mostafa Abdel Aziz, general surgery Assiut universitiy

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: I H repair by mesh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: age ,sex ,clinical diagnosis
• IPD Sharing Time Frame: 3 years
• IPD Sharing Access Criteria: age ,sex, clinical diagnosis
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No