Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial

Incisional Hernia Clinical Trial

Official title:

Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145908
• Other study ID #: Hazem nour midline closure
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hernia
• High Risk Patients
• Incisional Hernia
• Mesh Reinforcement
• Midline Incisions
• Surgical Wound

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