An interventional study of midline mesh reinforcement in Midline Incisions, High Risk Patients and Mesh Reinforcement, sponsored by Zagazig University. Completed. Per ClinicalTrials.gov, last updated 2019-10-31.
Sponsored by Zagazig University · Not applicable, Interventional, and Health services research
comparison between onlay and preperitoneal augmentation of mid line closure in high risk patients
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:
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 47 is below the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
patients underwent preperitoneal mesh mesh placement
Procedure: midline mesh reinforcement
patients underwent preperitoneal mesh mesh placement
Procedure: midline mesh reinforcement
augmentation of midline closure by nonabsorbsble mesh
midline incisional hernia ,
clinical and ultrasound examination of the abdomen for incisional hernia development
Time frame: weekly for one month , then monthly for 6 months then every 3 months later on till one year
post operative complications
hematoma , seroma, wound infection by clinical examination and\\or ultrasound
Time frame: (1st month post operative
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Zagazig University