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

Primary Purpose

Hernia

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
tissue Glue for mesh fixation
Metallic Tackers for mesh fixation
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring Laparoscopic TAPP, tissue glue, tackers, hernia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Jordan , faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

tissue glue

metallic tackers

Arm Description

mesh fixed using tissue glue

mesh fixed using metallic tackers

Outcomes

Primary Outcome Measures

postoperative pain
postoperative pain was measured using The visual analog scale ( VAS ) scored from 1-10

Secondary Outcome Measures

postoperative complications
postoperative complications including : seroma, ssi , hematoma and others
operative time
operative time
hospital stay
postoperative days in hospital measured

Full Information

First Posted
July 16, 2022
Last Updated
August 6, 2022
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT05466084
Brief Title
Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.
Acronym
TAVGLU
Official Title
A Randomized Controlled Trial Studying Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
Keywords
Laparoscopic TAPP, tissue glue, tackers, hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tissue glue
Arm Type
Experimental
Arm Description
mesh fixed using tissue glue
Arm Title
metallic tackers
Arm Type
Experimental
Arm Description
mesh fixed using metallic tackers
Intervention Type
Procedure
Intervention Name(s)
tissue Glue for mesh fixation
Intervention Description
one arm of the study had their mesh fixed with tissue glue applied at multiple sites
Intervention Type
Procedure
Intervention Name(s)
Metallic Tackers for mesh fixation
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative pain
Description
postoperative pain was measured using The visual analog scale ( VAS ) scored from 1-10
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
postoperative complications
Description
postoperative complications including : seroma, ssi , hematoma and others
Time Frame
6 weeks
Title
operative time
Description
operative time
Time Frame
intraoperative
Title
hospital stay
Description
postoperative days in hospital measured
Time Frame
6 WEEKS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Jordan , faculty of medicine
City
Amman
ZIP/Postal Code
11731
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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