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

A Randomized Controlled Trial Studying Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.

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 .

Study Overview

• Status: Completed
• Conditions: Hernia
• Intervention / Treatment: Procedure: tissue Glue for mesh fixation; Procedure: Metallic Tackers for mesh fixation

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11731
    • University of Jordan , faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: tissue glue; mesh fixed using tissue glue	Procedure: tissue Glue for mesh fixation; one arm of the study had their mesh fixed with tissue glue applied at multiple sites
EXPERIMENTAL: metallic tackers; mesh fixed using metallic tackers	Procedure: Metallic Tackers for mesh fixation; in the other arm mesh was fixed with tackers applied avoiding the triangle of pain and the triangle of doom using a three point fixation technique; Cooper's ligament, medial cranial edge of the mesh and just lateral to the inferior epigastric vessels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	postoperative pain was measured using The visual analog scale ( VAS ) scored from 1-10	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	postoperative complications including : seroma, ssi , hematoma and others	6 weeks
operative time	operative time	intraoperative
hospital stay	postoperative days in hospital measured	6 WEEKS

Collaborators and Investigators

• Sponsor: University of Jordan

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): August 30, 2021
• Study Completion (ACTUAL): July 1, 2022

Study Registration Dates

• First Submitted: July 16, 2022
• First Submitted That Met QC Criteria: July 16, 2022
• First Posted (ACTUAL): July 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 6, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: hernia; tissue glue; Laparoscopic TAPP; tackers
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 10/2022/4308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No