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Completed

NCT Number: NCT05466084

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

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 .

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Jordan , faculty of medicine

Amman, 11731, Jordan

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tissue Glue for mesh fixation

Procedure

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

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.

Primary outcomes

  1. postoperative pain

    Time frame: 6 weeks

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

Secondary outcomes

  1. postoperative complications

    Time frame: 6 weeks

    postoperative complications including : seroma, ssi , hematoma and others

  2. operative time

    Time frame: intraoperative

    operative time

  3. hospital stay

    Time frame: 6 WEEKS

    postoperative days in hospital measured

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

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

Acronym: TAVGLU

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 20, 2022
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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