Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial
Primary Purpose
Midline Incisions, High Risk Patients, Mesh Reinforcement
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
midline mesh reinforcement
Sponsored by
About this trial
This is an interventional health services research trial for Midline Incisions focused on measuring midline reinforcement, incisional hernia, mesh
Eligibility Criteria
Inclusion Criteria:
- Obesity
- Diabetes mellitus (DM),
- Steroid therapy,
- Liver diseases,
- Renal diseases,
- Cardiac diseases, Chest diseases ,
- Malignancy,
- Nutritional deficiency
- Old age
Exclusion Criteria:
- non risk factor
- previous incisional hernia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
preperitoneal mesh
onlay mesh
Arm Description
patients underwent preperitoneal mesh mesh placement
patients underwent preperitoneal mesh mesh placement
Outcomes
Primary Outcome Measures
midline incisional hernia ,
clinical and ultrasound examination of the abdomen for incisional hernia development
Secondary Outcome Measures
post operative complications
hematoma , seroma, wound infection by clinical examination and\or ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04145908
Brief Title
Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial
Official Title
Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Group I: wound closure is reinforced by onlay polypropylene mesh (24 patients)
Group II: wound closure is reinforced by preperitoneal polypropylene mesh (23 patients).
In both groups midline laparotomy was closed by non-absorbable continuous suture, 4\1 ratio reinforced with interrupted sutures every 4 bites.
All patients were subjected to: full history taking and clinical examination, radiological and laboratory investigations and endoscopy if needed.
SURGICAL TECHNIQUE In group I patients, after completion of the deemed surgery, the linea alba was closed as mentioned before, then the subcutaneous tissue was dissected of the anterior rectus sheath for 2 cm on both sides, then a polypropylene mesh strip 4 cm width and 4 cm longer than the wound length was applied and centered over the wound, fixed in the onlay position using prolene sutures 2\0. Suction drain is left in position, subcutaneous tissue and skin closed as per usual.
In group II patients, a preperitoneal pocket is created at the time of opening the mid line figure, linea alba is incised separately from peritoneum to facilitate formation of preperitoneal pocket , at time of closure, the mesh was inserted in the preperitoneal space after peritoneal closure with Vicryl 3\0 sutures, the mesh is fixed to the peritoneum by 4 stitches in the 4 quadrants , and to linea alba during midline closure , suction drain was left in the preperitoneal space.
Follow up Patients were followed up in outpatient clinic, (weekly for the first month then monthly for the first six months and lastly every 3 months for one year( in each visit they were carefully examined for any wound occurrences or hernia development, superficial probe ultrasonic examination of abdominal wall was done after 1 week and after 1 month. Demographic data, preoperative, operative and follow up data was collected tabulated and analyzed using SPSS 22 program package.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Midline Incisions, High Risk Patients, Mesh Reinforcement, Incisional Hernia
Keywords
midline reinforcement, incisional hernia, mesh
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups one group for onlay mesh position the other for preperitoneal position
Masking
Participant
Masking Description
patient don't know the procedure
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
preperitoneal mesh
Arm Type
Active Comparator
Arm Description
patients underwent preperitoneal mesh mesh placement
Arm Title
onlay mesh
Arm Type
Active Comparator
Arm Description
patients underwent preperitoneal mesh mesh placement
Intervention Type
Procedure
Intervention Name(s)
midline mesh reinforcement
Intervention Description
augmentation of midline closure by nonabsorbsble mesh
Primary Outcome Measure Information:
Title
midline incisional hernia ,
Description
clinical and ultrasound examination of the abdomen for incisional hernia development
Time Frame
weekly for one month , then monthly for 6 months then every 3 months later on till one year
Secondary Outcome Measure Information:
Title
post operative complications
Description
hematoma , seroma, wound infection by clinical examination and\or ultrasound
Time Frame
(1st month post operative
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obesity
Diabetes mellitus (DM),
Steroid therapy,
Liver diseases,
Renal diseases,
Cardiac diseases, Chest diseases ,
Malignancy,
Nutritional deficiency
Old age
Exclusion Criteria:
non risk factor
previous incisional hernia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial
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