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

October 28, 2019 updated by: Hazem Nour Abdellatif, Zagazig University
comparison between onlay and preperitoneal augmentation of mid line closure in high risk patients

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: preperitoneal mesh
patients underwent preperitoneal mesh mesh placement
augmentation of midline closure by nonabsorbsble mesh
Active Comparator: onlay mesh
patients underwent preperitoneal mesh mesh placement
augmentation of midline closure by nonabsorbsble mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
weekly for one month , then monthly for 6 months then every 3 months later on till one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative complications
Time Frame: (1st month post operative
hematoma , seroma, wound infection by clinical examination and\or ultrasound
(1st month post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

October 31, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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