- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04145908
Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hazem nour midline closure
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Incisional Hernia
-
W.L.Gore & AssociatesRecruitingHernia, Ventral | Hernia Incisional | Hernia Incisional VentralUnited States, Spain, Italy, United Kingdom
-
Zagazig UniversityCompletedIncisional Hernia of Midline of Abdomen | Incisional Hernia of Midline of Upper Abdomen | Incisional Hernia of Midline of Lower AbdomenEgypt
-
C. R. BardCompletedHernia | Hernia, Abdominal | Hernia, IncisionalBelgium, Netherlands, Denmark, France, Italy, United Kingdom, Austria, Germany
-
Mansoura UniversityUnknownHernia, Abdominal | Hernia, Ventral | Hernia IncisionalEgypt
-
Hospital Central "Dr. Ignacio Morones Prieto"UnknownHernia, Ventral | Ventral Incisional Hernia
-
Universitaire Ziekenhuizen KU LeuvenBelgian Section for Abdominal Wall Surgery, section of the Royal Belgian...Not yet recruitingVentral Incisional Hernia
-
University of PennsylvaniaCompleted
-
Azienda Sanitaria Locale Napoli 2 NordCompletedHernia, Abdominal | Hernia IncisionalItaly
-
Medtronic - MITGCompletedVentral Incisional HerniaFrance
-
Hospital Regional de Alta Especialidad del BajioCompleted
Clinical Trials on midline mesh reinforcement
-
Hospital Regional de Alta Especialidad del BajioCompleted
-
Karolinska InstitutetStockholm South General HospitalRecruiting
-
Medtronic - MITGTerminatedIncisional HerniaFrance
-
Skane University HospitalLund University; Ethicon, Inc.; Crafoord Foundation; Region Skåne FoUU; The Einar... and other collaboratorsCompletedHERNIA, VENTRALSweden
-
Hospices Civils de LyonRecruiting
-
Mayo ClinicCompleted
-
University of Sao Paulo General HospitalCompletedSurgical Wound DehiscenceBrazil
-
University of Campania "Luigi Vanvitelli"CompletedIncisional Hernia
-
W.L.Gore & AssociatesCompletedVentral Incisional HerniaUnited States, Netherlands
-
Washington University School of MedicineTerminated