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Completed

NCT Number: NCT03434301

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

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.

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Key information

Conditions

Incisional Hernia Abdominal Hernia Hernia Hernia, Abdominal Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ReliaTack™

Device

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

Protack™

Device

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

Primary outcomes

  1. Pain score

    Time frame: 30 days

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

Secondary outcomes

  1. Visual analogue pain score (VAS).

    Time frame: Day 1, days 5-7, 3 months, 1 year.

    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.

  2. Seroma formation.

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

    Seroma formation (no fixed time point) (a seroma will be defined as any clinically apparent fluid collection at the site of mesh placement).

  3. Postoperative hospital stay.

    Time frame: Time from end of Surgery to patient discharge (up to end of study; 104 weeks).

    The length of postoperative hospital stay.

  4. Time to return to normal daily activity.

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

    The time to return to normal daily activity.

  5. Wound infection.

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

    Any wound infection.

  6. Operating time.

    Time frame: Length of Operation.

    The time taken for the Operation - from start to finish.

  7. Mesh fixation time.

    Time frame: Time during Operation.

    Mesh fixation time after adhesions have been taken down and fascia closed.

  8. Hernia recurrence.

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

    Hernia recurrence at one year and at all time points.

  9. Health-related quality of life.

    Time frame: 30 days and 1 year post-operation.

    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).

  10. Adverse Events.

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

    To capture any Adverse Events during the study duration.

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: TACKoMesh

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2018
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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