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

NCT05359510 | Unknown

• 1 other identifier: I H repair by mesh
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• complication rate

  intraoperative complications will be recorded immediately after finishing the operation

• incidence of incisional hernia

  12 month

Study Arms (1)

patient with various abdominal incisions to be operated

EXPERIMENTAL

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

Interventions

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

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

patient with various abdominal incisions to be operated

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent
• patient age: ≥ 18 years
• patients undergoing elective or urgent open abdominal surgical procedure regardless of benign or malignant disease

You may not qualify if:

• age \<18 years
• navel site infection
• pregnancy
• expected survival \<12 month
• previous intra abdominal mesh placement

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Mostafa Abdel Aziz

  general surgery Assiut universitiy

  STUDY CHAIR

Central Study Contacts

kerolos samer, Reside doctor

CONTACT

+201277838435; kerolos.samer1295@gmail.com

Ahmed Soliman, prof ofsurgery

CONTACT

01091672661; ahmedmmsoliman@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 4, 2022
• Study Start: April 26, 2022
• Primary Completion: September 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 3 years
• Access Criteria: age ,sex, clinical diagnosis

Locations

EG (1)