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

NCT ID: NCT05359510

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-26
• Study Completion Date: 2022-11-01

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.

Conditions

Incisional Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patient with various abdominal incisions to be operated

patients with various abdominal incisions for closure either by primary suturing or by mesh

Group Type: EXPERIMENTAL

prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturing

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

closure of various abdominal incision by different types of prophylactic mesh at different sites for prevention of incisional hernia versus primary abdominal closure

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Kerolos Samer Shafik

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mostafa Abdel Aziz

Role: STUDY_CHAIR

general surgery Assiut universitiy

Locations

Assiut University

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

kerolos samer, Reside doctor

Role: CONTACT

kerolos.samer1295@gmail.com

+201277838435

Ahmed Soliman, prof ofsurgery

Role: CONTACT

ahmedmmsoliman@yahoo.com

01091672661

Other Identifiers

I H repair by mesh

Identifier Type: -

Identifier Source: org_study_id