Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of

Status Completed

Clinical Trial 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.

Clinical Trial Description

TACKoMESH study (Comparison of using absorbable tacks (ReliaTack™) against a non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia) is a prospective, single-centre, double blinded randomised trial which aims to establish whether the use of absorbable (ABS) compared to non-absorbable (Non-ABS) tacks in adult patients undergoing elective incisional hernia repair produces a lower rate of pain both immediately and long-term. Secondary outcomes to be explored include seroma formation, hernia recurrence, length of postoperative hospital stay, wound infection, reoperation rate, operation time, health related quality of life and time to return to normal daily activity. Patients entering TACKoMesh will be randomised immediately prior to their operation with a 1:1 ratio of ABS versus Non-ABS tack arm allocation. The same composite mesh will be used for all operations. Follow-up is according to a predetermined schedule, using specifically designed Case Report Forms to collect the blinded data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03434301
Study type	Interventional
Source	Manchester University NHS Foundation Trust
Contact
Status	Completed
Phase	N/A
Start date	July 20, 2017
Completion date	September 22, 2020

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms