Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal Inguinal Hernia Repair Without Mesh Fixation
NCT ID: NCT04532983
Last Updated: 2020-08-31
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
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COMPLETED
NA
46 participants
INTERVENTIONAL
2018-07-01
2020-06-30
Brief Summary
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Detailed Description
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Patient selection; In this study we enrolled patients above
* 18 years old suffering unilateral,
* non -recurrent,
* un-complicated inguinal hernia. We excluded patients with
* previous abdominal or pelvic surgery,
* unfit with laparoscopic surgery,
* those with ascites,
* abdominal malignancy
* on chemotherapy and immune-compromised patients.
Randomization; using computer generated random numbers , the study participants were randomly allocated into two equal groups each group 23 individual, the first group; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), and group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.
All the study participants were subjected to thorough history taking, detailed clinical examination, determination of the presence of inguinal hernia, measurement of the hernia defect diameter by ultrasound or computerized tomography in difficult cases, preoperative laboratory tests were performed as per usual
Follow up Early postoperative data during the admission were collected, a; pain score (measured by visual analogue scale (VAS), hematoma formation, early recurrence, time needed for ambulation.
Follow up was carried out in outpatients clinics by the attending surgeon after 1 week, 1 month,3 months and 6 months of the operation , the recorded follow up data included wound complications, seroma formation, foreign body sensation and recurrence.
The study was approved by the local ethical committee and institutional review board (IRB) of our university hospitals, all patients signed an informed written consent before participation in this study Preoperative, demographic, operative and postoperative data were collected and properly analyzed using t test, Z test in SPSS 22 program package
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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fixation group
; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic),
fixation of mesh prosthesis
in the first group mesh was fixed in position with laparoscopic tacks
non fixation group
group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation.
mesh placement without fixation
mesh placement in preperitoneal space without fixation
Interventions
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fixation of mesh prosthesis
in the first group mesh was fixed in position with laparoscopic tacks
mesh placement without fixation
mesh placement in preperitoneal space without fixation
Eligibility Criteria
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Inclusion Criteria
* non -recurrent,
* un-complicated inguinal hernia.
Exclusion Criteria
* unfit with laparoscopic surgery,
* those with ascites,
* abdominal malignancy
* on chemotherapy and immune-compromised patients.
18 Years
ALL
No
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Hazem Nour Abdellatif
Assistant professor
Principal Investigators
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hazem nour
Role: PRINCIPAL_INVESTIGATOR
zag university
Locations
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Zagazig Faculty of Medicine
Zagazig, Sharqya, Egypt
Countries
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Other Identifiers
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hazem tapp no fix
Identifier Type: -
Identifier Source: org_study_id