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

NCT05466084 | Completed

• 1 other identifier: 10/2022/4308
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 .

Conditions

Hernia

Keywords

Laparoscopic TAPP; tissue glue; tackers; hernia

Outcome Measures

Primary Outcomes (1)

• postoperative pain

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

  6 weeks

Secondary Outcomes (3)

• postoperative complications

  6 weeks

• operative time

  intraoperative

• hospital stay

  6 WEEKS

Study Arms (2)

tissue glue

EXPERIMENTAL

mesh fixed using tissue glue

Procedure: tissue Glue for mesh fixation

metallic tackers

EXPERIMENTAL

mesh fixed using metallic tackers

Procedure: Metallic Tackers for mesh fixation

Interventions

tissue Glue for mesh fixation PROCEDURE

one arm of the study had their mesh fixed with tissue glue applied at multiple sites

tissue glue

Metallic Tackers for mesh fixation PROCEDURE

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.

metallic tackers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

University of Jordan , faculty of medicine

Amman, 11731, Jordan

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General surgery specialist

Model Details: randomized control trial

Study Record Dates

• First Submitted: July 16, 2022
• First Posted: July 20, 2022
• Study Start: January 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: July 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)