Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zagazig University
- Enrollment
- 47
- Primary Endpoint
- midline incisional hernia ,
Study Overview
Brief Summary
comparison between onlay and preperitoneal augmentation of mid line closure in high risk patients
Detailed Description
This study is a randomized comparative clinical trial, carried out in the period from July 2016 to August, 2019, on 47 high-risk patients who are liable to develop incisional hernia, after elective abdominal operations through midline incisions.
High-risk patients means patients who had one or more of the factors that make them more liable to develop incisional hernia, as Obesity, Diabetes mellitus (DM), Steroid therapy, Liver diseases, Renal diseases, Cardiac diseases, Chest diseases , Malignancy, Nutritional deficiency and Old age.
Institutional Review Board, the ethical committee approved the study, determined the number of the study patients, all patients were informed and consented.
Randomization was carried out by assistant nurse using randomization computer program.
The patients were randomly divided into two groups:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Masking Description
patient don't know the procedure
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diabetes mellitus (DM),
- •Steroid therapy,
- •Liver diseases,
- •Renal diseases,
- •Cardiac diseases, Chest diseases ,
- •Malignancy,
- •Nutritional deficiency
Exclusion Criteria
- •non risk factor
- •previous incisional hernia
Arms & Interventions
preperitoneal mesh
patients underwent preperitoneal mesh mesh placement
Intervention: midline mesh reinforcement (Procedure)
onlay mesh
patients underwent preperitoneal mesh mesh placement
Intervention: midline mesh reinforcement (Procedure)
Outcomes
Primary Outcomes
midline incisional hernia ,
Time Frame: weekly for one month , then monthly for 6 months then every 3 months later on till one year
clinical and ultrasound examination of the abdomen for incisional hernia development
Secondary Outcomes
- post operative complications((1st month post operative)
Investigators
Hazem Nour Abdellatif
Assistant professor
Zagazig University