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

University of Jordan50 enrolled

Overview

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 .

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hernia

Interventions

tissue Glue for mesh fixationPROCEDURE

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

Metallic Tackers for mesh fixationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Jordan , faculty of medicine

Amman, Jordan

Outcomes

Primary Outcomes

postoperative pain

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

Time frame: 6 weeks

Secondary Outcomes

postoperative complications

postoperative complications including : seroma, ssi , hematoma and others

Time frame: 6 weeks

operative time

Time frame: intraoperative

hospital stay

postoperative days in hospital measured

Time frame: 6 WEEKS

Data from ClinicalTrials.gov

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