Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial
NCT ID: NCT04145908
Last Updated: 2019-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
47 participants
INTERVENTIONAL
2016-07-31
2019-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
preperitoneal mesh
patients underwent preperitoneal mesh mesh placement
midline mesh reinforcement
augmentation of midline closure by nonabsorbsble mesh
onlay mesh
patients underwent preperitoneal mesh mesh placement
midline mesh reinforcement
augmentation of midline closure by nonabsorbsble mesh
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
midline mesh reinforcement
augmentation of midline closure by nonabsorbsble mesh
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diabetes mellitus (DM),
* Steroid therapy,
* Liver diseases,
* Renal diseases,
* Cardiac diseases, Chest diseases ,
* Malignancy,
* Nutritional deficiency
* Old age
Exclusion Criteria
* previous incisional hernia
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zagazig University
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hazem Nour Abdellatif
Assistant professor
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Hazem nour midline closure
Identifier Type: -
Identifier Source: org_study_id