Clinical trial NCT04145908: 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
Overall status: COMPLETED
Phase: NA
Conditions: Midline Incisions
High Risk Patients
Mesh Reinforcement
Incisional Hernia
Keywords: midline reinforcement
incisional hernia
mesh
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-10-31
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups one group for onlay mesh position the other for preperitoneal position
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: midline incisional hernia ,
timeFrame: weekly for one month , then monthly for 6 months then every 3 months later on till one year
Secondary outcomes:
measure: post operative complications
timeFrame: (1st month post operative
Other outcomes:
Locations:
Study officials:
References: