Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal Inguinal Hernia Repair Without Mesh Fixation

Study Overview
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Brief Summary
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comparison between two groups of participants suffering inguinal hernia each group 23 individual all underwent laparoscopic trans-abdominal inguinal hernia repair first group received mesh fixation the second underwent no fixation , results of follow up in the first year were compared together

Detailed Description
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This comparative study was performed in Zagazig university hospitals, general surgery department in the time period between july 2018 and june 2020 0n 46 patients undergoing laparoscopic trans abdominal preperitoneal (TAPP) repair for un complicated unilateral inguinal hernia. 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

Official Title
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Short Term Outcome of Laparoscopic Trans-abdominal Preperitoneal (TAPP) Inguinal Hernia Repair Without Mesh Fixation, Comparative Study

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: fixation of mesh prosthesis
* Procedure: mesh placement without fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old suffering unilateral, non -recurrent, un-complicated inguinal hernia. Exclusion Criteria: previous abdominal or pelvic surgery, unfit with laparoscopic surgery, those with ascites, abdominal malignancy on chemotherapy and immune-compromised patients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: ; 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fixation group<br>; group A; patients underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was fixed in position using absorbable Vicryl tacks (abstack30 medtronic), | Procedure: fixation of mesh prosthesis<br>* in the first group mesh was fixed in position with laparoscopic tacks<br>|
| Active Comparator: non fixation group<br>group B patient underwent laparoscopic TAPP repair of inguinal hernia and the mesh prosthesis was placed in position without fixation. | Procedure: mesh placement without fixation<br>* mesh placement in preperitoneal space without fixation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | pain in the first 6 month of surgery measured by visual analogue scale | 6 month | 
| hernia recurrence | recurrence of inguinal hernia measured by computed tomography of the abdomen | 1 year |