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

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NHS Foundation Trust

Status

Completed

Conditions

Incisional Hernia
Hernia
Abdominal Hernia

Treatments

Device: ReliaTack™
Device: Protack™

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03434301
R04484

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

63 participants in 2 patient groups

Mesh with absorbable tack fixation
Active Comparator group
Description:
Mesh with absorbable tack (ReliaTack™) fixation
Treatment:
Device: ReliaTack™
Mesh with non-absorbable fixation
Active Comparator group
Description:
Mesh with non-absorbable (Protack™) fixation
Treatment:
Device: Protack™

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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