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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04145908
Other study ID # Hazem nour midline closure
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2016
Est. completion date August 2019

Study information

Verified date October 2019
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

comparison between onlay and preperitoneal augmentation of mid line closure in high risk patients


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date August 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

Procedure:
midline mesh reinforcement
augmentation of midline closure by nonabsorbsble mesh

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Outcome

Type Measure Description Time frame Safety issue
Primary midline incisional hernia , clinical and ultrasound examination of the abdomen for incisional hernia development weekly for one month , then monthly for 6 months then every 3 months later on till one year
Secondary post operative complications hematoma , seroma, wound infection by clinical examination and\or ultrasound (1st month post operative
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