MedTrace Logo

Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™

NCT03434301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-12-07

No results posted yet for this study

Summary

This study is designed to examine the effects on post operative pain after the use of a fixation device to secure a mesh in the abdomen to repair a hernia of the abdominal wall. The fixation devices to be used differ with one being made from titanium and is permanent and the other being made from an absorbable material. Both fixation devices are commonly used but two questions remain unanswered, does one cause more chronic pain and also what if any will be the effect on recurrence rates of the hernia. No trial has been undertaken to date which will not only examine the fixation device but in the setting where the hernia is closed first. The closure of the hernial defect by the keyhole technique is a relatively new and growing concept in the hernia world.

Conditions

  • Incisional Hernia
  • Hernia
  • Abdominal Hernia

Interventions

DEVICE

ReliaTack™

Absorbable tack (ReliaTack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.

DEVICE

Protack™

Non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Aali J Sheen · Manchester University NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2020-09-22
Completion
2020-09-22

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03434301 on ClinicalTrials.gov