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

Primary Purpose

Incisional Hernia, Hernia, Abdominal Hernia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ReliaTack™
Protack™
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incisional Hernia focused on measuring Surgery, Laparotomy, Tack, Non-absorbable Tack, Absorbable Tack, Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Manchester University NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mesh with absorbable tack fixation

Mesh with non-absorbable fixation

Arm Description

Mesh with absorbable tack (ReliaTack™) fixation

Mesh with non-absorbable (Protack™) fixation

Outcomes

Primary Outcome Measures

Pain score
Pain Score at rest and activity at day 30 recorded using visual analogue pain score (VAS) (0-10cm).

Secondary Outcome Measures

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.
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).
Postoperative hospital stay.
The length of postoperative hospital stay.
Time to return to normal daily activity.
The time to return to normal daily activity.
Wound infection.
Any wound infection.
Operating time.
The time taken for the Operation - from start to finish.
Mesh fixation time.
Mesh fixation time after adhesions have been taken down and fascia closed.
Hernia recurrence.
Hernia recurrence at one year and at all time points.
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).
Adverse Events.
To capture any Adverse Events during the study duration.

Full Information

First Posted
January 29, 2018
Last Updated
December 6, 2021
Sponsor
Manchester University NHS Foundation Trust
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT03434301
Brief Title
Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™
Acronym
TACKoMesh
Official Title
Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™ (TACKoMesh Study)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
September 22, 2020 (Actual)
Study Completion Date
September 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia, Hernia, Abdominal Hernia
Keywords
Surgery, Laparotomy, Tack, Non-absorbable Tack, Absorbable Tack, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesh with absorbable tack fixation
Arm Type
Active Comparator
Arm Description
Mesh with absorbable tack (ReliaTack™) fixation
Arm Title
Mesh with non-absorbable fixation
Arm Type
Active Comparator
Arm Description
Mesh with non-absorbable (Protack™) fixation
Intervention Type
Device
Intervention Name(s)
ReliaTack™
Intervention Description
Absorbable tack (ReliaTack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.
Intervention Type
Device
Intervention Name(s)
Protack™
Intervention Description
Non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.
Primary Outcome Measure Information:
Title
Pain score
Description
Pain Score at rest and activity at day 30 recorded using visual analogue pain score (VAS) (0-10cm).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Visual analogue pain score (VAS).
Description
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.
Time Frame
Day 1, days 5-7, 3 months, 1 year.
Title
Seroma formation.
Description
Seroma formation (no fixed time point) (a seroma will be defined as any clinically apparent fluid collection at the site of mesh placement).
Time Frame
Days 1, 6, 30, 3 months and 1 year post-operation.
Title
Postoperative hospital stay.
Description
The length of postoperative hospital stay.
Time Frame
Time from end of Surgery to patient discharge (up to end of study; 104 weeks).
Title
Time to return to normal daily activity.
Description
The time to return to normal daily activity.
Time Frame
From day of surgery to end of study (104 weeks).
Title
Wound infection.
Description
Any wound infection.
Time Frame
Days 1, 6, 30, 3 months and 1 year post-operation.
Title
Operating time.
Description
The time taken for the Operation - from start to finish.
Time Frame
Length of Operation.
Title
Mesh fixation time.
Description
Mesh fixation time after adhesions have been taken down and fascia closed.
Time Frame
Time during Operation.
Title
Hernia recurrence.
Description
Hernia recurrence at one year and at all time points.
Time Frame
Days 1, 6, 30, 3 months and 1 year post-operation.
Title
Health-related quality of life.
Description
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).
Time Frame
30 days and 1 year post-operation.
Title
Adverse Events.
Description
To capture any Adverse Events during the study duration.
Time Frame
Days 1, 6, 30, 3 months and 1 year post-operation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aali J Sheen
Organizational Affiliation
Manchester University NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29996841
Citation
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.
Results Reference
derived

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

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