Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.

Not Applicable

Completed

• Conditions: Hernia
• Interventions: Procedure: tissue Glue for mesh fixation; Procedure: Metallic Tackers for mesh fixation

• Registration Number: NCT05466084
• Lead Sponsor: University of Jordan

Brief Summary

This is a randomized control trial intending to study the clinical difference between different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .

Detailed Description

Laparoscopic transabdominal preperitoneal ( TAPP ) hernioplasty has emerged as an essential procedure for adults complaining of both unilateral and bilateral inguinal hernia , various descriptions of the procedure have been published recently, complications and recurrence rates are being calculated for each method, different mesh fixation techniques are being used by different surgeons, some use surgical tackers, some use fibrin glue and some demonstrated an equal outcome if the mesh was not fixed at all.

This is a randomized control trial intending to study the clinical difference between those different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-08-30
• Study Completion: 2022-07-01
• Study First Submitted: 2022-07-16
• Study First Submitted QC: 2022-07-16
• Study First Posted: 2022-07-20
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-06
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• all Adult Patients ages between 18 and 80 years old, males and females, inguinal hernias, unilateral or bilateral and femoral hernias.

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Exclusion Criteria

• operations which were converted from TAPP to other procedures (such as open repair or TEP).
• Patients who were unfit for general anesthesia
• patients who refused to participate in the study
• patients with chronic pain disorders requiring long term pain management before the procedure.
• cases with complicated hernias that required emergency repair.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tissue glue	tissue Glue for mesh fixation	mesh fixed using tissue glue
metallic tackers	Metallic Tackers for mesh fixation	mesh fixed using metallic tackers

Primary Outcome Measures

Name	Time	Method
postoperative pain	6 weeks	postoperative pain was measured using The visual analog scale ( VAS ) scored from 1-10

Secondary Outcome Measures

Name	Time	Method
hospital stay	6 WEEKS	postoperative days in hospital measured
operative time	intraoperative	operative time
postoperative complications	6 weeks	postoperative complications including : seroma, ssi , hematoma and others

Trial Locations

Locations (1)

University of Jordan , faculty of medicine; 🇯🇴 Amman, Jordan