The Use of Different Types of Mesh for Prevention of Incisional Hernia Versus Primary Abdominal Suturing
Primary Purpose
Incisional Hernia
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturing
Sponsored by
About this trial
This is an interventional treatment trial for Incisional Hernia
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
Sites / Locations
- Assiut UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient with various abdominal incisions to be operated
Arm Description
patients with various abdominal incisions for closure either by primary suturing or by mesh
Outcomes
Primary Outcome Measures
early wound complications
wound infection (with or without removal of the mesh) ,wound necrosis , wound hematoma
late wound complications
post operative incisional hernia, wound infection (with or without removal of the mesh) wound necrosis wound hematoma.
Secondary Outcome Measures
complication rate
major bleeding bowel injury
incidence of incisional hernia
the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05359510
Brief Title
The Use of Different Types of Mesh for Prevention of Incisional Hernia Versus Primary Abdominal Suturing
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient with various abdominal incisions to be operated
Arm Type
Experimental
Arm Description
patients with various abdominal incisions for closure either by primary suturing or by mesh
Intervention Type
Procedure
Intervention Name(s)
prophylactic mesh repair at different sites for prevention of incisional hernia after various abdominal incision versus primary abdominal suturing
Other Intervention Name(s)
closure of various abdominal incision by different types of prophylactic mesh at different sites for prevention of incisional hernia versus primary abdominal closure
Intervention Description
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.
Primary Outcome Measure Information:
Title
early wound complications
Description
wound infection (with or without removal of the mesh) ,wound necrosis , wound hematoma
Time Frame
1 month
Title
late wound complications
Description
post operative incisional hernia, wound infection (with or without removal of the mesh) wound necrosis wound hematoma.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
complication rate
Description
major bleeding bowel injury
Time Frame
intraoperative complications will be recorded immediately after finishing the operation
Title
incidence of incisional hernia
Description
the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups.
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kerolos samer, Reside doctor
Phone
+201277838435
Email
kerolos.samer1295@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Soliman, prof ofsurgery
Phone
01091672661
Email
ahmedmmsoliman@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa Abdel Aziz
Organizational Affiliation
general surgery Assiut universitiy
Official's Role
Study Chair
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
age ,sex ,clinical diagnosis
IPD Sharing Time Frame
3 years
IPD Sharing Access Criteria
age ,sex, clinical diagnosis
Learn more about this trial
The Use of Different Types of Mesh for Prevention of Incisional Hernia Versus Primary Abdominal Suturing
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