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

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

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.

Study Overview

• Status: Completed
• Conditions: Hernia; Abdominal Hernia; Incisional Hernia
• Intervention / Treatment: Device: ReliaTack™; Device: Protack™

Detailed 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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WL
    • Manchester University NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All adults undergoing elective incisional hernia repair for midline abdominal incisional hernia, with a defect of 3-10cm in diameter.

Exclusion Criteria:

• Patients less than 18 years of age, or unable to give informed consent.
• Patients over 80 years of age.
• Females of reproductive age.
• Prisoners.
• Clinically small incisional hernia <3cm maximum diameter.
• Emergency procedures (for irreducible, strangulated or obstructed hernia).
• Procedure involving dirty (purulent inflammation (e.g. abscess); preoperative perforation of respiratory, gastrointestinal, biliary or genitourinary tract; penetrating trauma >4 hours old) or contaminated (Non-purulent inflammation; gross spillage from gastrointestinal tract; entry into biliary or genitourinary tract in the presence of infected bile or urine; major break in technique; penetrating trauma <4 hours old; chronic open wounds to be grafted or covered) surgery.
• Patients with a Body Mass Index (BMI) >40 kg/m².
• Patients participating in any other study, whose concurrent participation in the TACK study might place them at undue risk or might confound the study data in the opinion of the chief investigators.
• Failure to close the anterior rectus sheath intraoperatively.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mesh with absorbable tack fixation; Mesh with absorbable tack (ReliaTack™) fixation	Device: ReliaTack™; Absorbable tack (ReliaTack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.
Active Comparator: Mesh with non-absorbable fixation; Mesh with non-absorbable (Protack™) fixation	Device: Protack™; Non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain Score at rest and activity at day 30 recorded using visual analogue pain score (VAS) (0-10cm).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue pain score (VAS).	Visual analogue pain score (VAS) pain score at days 1, 5-7 3 months and 1 year post-operative. A preoperative VAS score will also be recorded.	Day 1, days 5-7, 3 months, 1 year.
Seroma formation.	Seroma formation (no fixed time point) (a seroma will be defined as any clinically apparent fluid collection at the site of mesh placement).	Days 1, 6, 30, 3 months and 1 year post-operation.
Postoperative hospital stay.	The length of postoperative hospital stay.	Time from end of Surgery to patient discharge (up to end of study; 104 weeks).
Time to return to normal daily activity.	The time to return to normal daily activity.	From day of surgery to end of study (104 weeks).
Wound infection.	Any wound infection.	Days 1, 6, 30, 3 months and 1 year post-operation.
Operating time.	The time taken for the Operation - from start to finish.	Length of Operation.
Mesh fixation time.	Mesh fixation time after adhesions have been taken down and fascia closed.	Time during Operation.
Hernia recurrence.	Hernia recurrence at one year and at all time points.	Days 1, 6, 30, 3 months and 1 year post-operation.
Health-related quality of life.	Health-related quality of life - assessed using the Carolinas Comfort Score™ (which is specifically designed for hernia repair) (26) and Short Form 36™, at pre-operatively, 30 days and 1 year, (appendix K and SF-36).	30 days and 1 year post-operation.
Adverse Events.	To capture any Adverse Events during the study duration.	Days 1, 6, 30, 3 months and 1 year post-operation.

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: Medtronic
• Investigators: Principal Investigator: Aali J Sheen, Manchester University NHS Foundation Trust

Publications and helpful links

General Publications

• Sheen AJ, Pilkington JJ, Baltatzis M, Tyurkylmaz A, Stathakis P, Jamdar S, Siriwardena AK. Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia-ReliaTack v ProTack (TACKoMesh) - A double-blind randomised controlled trial. BMC Surg. 2018 Jul 11;18(1):46. doi: 10.1186/s12893-018-0378-3.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Actual): September 22, 2020
• Study Completion (Actual): September 22, 2020

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Surgery; Laparotomy; Tack; Non-absorbable Tack; Absorbable Tack
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Internal Hernia; Incisional Hernia
• Other Study ID Numbers: R04484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No