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

NCT ID: NCT05466084

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-07-01

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 .

Conditions

Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tissue glue

mesh fixed using tissue glue

Group Type: EXPERIMENTAL

tissue Glue for mesh fixation

Intervention Type: PROCEDURE

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

metallic tackers

mesh fixed using metallic tackers

Group Type: EXPERIMENTAL

Metallic Tackers for mesh fixation

Intervention Type: 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.

Interventions

tissue Glue for mesh fixation

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

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Hanan Ibrahim Mansour

General surgery specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Jordan , faculty of medicine

Amman, , Jordan

Countries

Jordan

Other Identifiers

10/2022/4308

Identifier Type: -

Identifier Source: org_study_id