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

Incisional Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05359510
• Other study ID #: I H repair by mesh
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: August 2022
• Source: Assiut University
• Contact: kerolos samer, Reside doctor
• Phone: +201277838435
• Email: kerolos.samer1295[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: November 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

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.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early wound complications	wound infection (with or without removal of the mesh) ,wound necrosis , wound hematoma	1 month
Primary	late wound complications	post operative incisional hernia, wound infection (with or without removal of the mesh) wound necrosis wound hematoma.	1 month
Secondary	complication rate	major bleeding bowel injury	intraoperative complications will be recorded immediately after finishing the operation
Secondary	incidence of incisional hernia	the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups.	12 month