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

NCT03434301 | Completed

• 1 other identifier: R04484
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Incisional Hernia; Hernia; Abdominal Hernia

Keywords

Surgery; Laparotomy; Tack; Non-absorbable Tack; Absorbable Tack; Pain

Outcome Measures

Primary Outcomes (1)

• Pain score

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

  30 days

Secondary Outcomes (10)

• Visual analogue pain score (VAS).

  Day 1, days 5-7, 3 months, 1 year.

• Seroma formation.

  Days 1, 6, 30, 3 months and 1 year post-operation.

• 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.

  From day of surgery to end of study (104 weeks).

• Wound infection.

  Days 1, 6, 30, 3 months and 1 year post-operation.

Study Arms (2)

Mesh with absorbable tack fixation

ACTIVE COMPARATOR

Mesh with absorbable tack (ReliaTack™) fixation

Device: ReliaTack™

Mesh with non-absorbable fixation

ACTIVE COMPARATOR

Mesh with non-absorbable (Protack™) fixation

Device: Protack™

Interventions

ReliaTack™ DEVICE

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

Mesh with absorbable tack fixation

Protack™ DEVICE

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

Mesh with non-absorbable fixation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Medtronic: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29996841 DERIVED

MeSH Terms

Conditions

Incisional Hernia; Hernia; Hernia, Abdominal; Pain

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Aali J Sheen

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 15, 2018
• Study Start: July 20, 2017
• Primary Completion: September 22, 2020
• Study Completion: September 22, 2020
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)