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

Hernia Clinical Trial

— TAVGLU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05466084
• Other study ID #: 10/2022/4308
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2022
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 1, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia

Intervention

Procedure:
• tissue Glue for mesh fixation
one arm of the study had their mesh fixed with tissue glue applied at multiple sites
• 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.

Locations

Country	Name	City	State
Jordan	University of Jordan , faculty of medicine	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	postoperative pain was measured using The visual analog scale ( VAS ) scored from 1-10	6 weeks
Secondary	postoperative complications	postoperative complications including : seroma, ssi , hematoma and others	6 weeks
Secondary	operative time	operative time	intraoperative
Secondary	hospital stay	postoperative days in hospital measured	6 WEEKS