Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia-ReliaTack™ v ProTack™ (TACKoMesh) - A double-blind randomised controlled trial

Abstract

Background: Minimally invasive incisional hernia repair has been established as a safe and efficient surgical option in most centres worldwide. Laparoscopic technique includes the placement of an intraperitoneal onlay mesh with fixation achieved using spiral tacks or sutures. An additional step is the closure of the fascial defect depending upon its size. Key outcomes in the evaluation of ventral abdominal hernia surgery include postoperative pain, the presence of infection, seroma formation and hernia recurrence. TACKoMESH is a randomised controlled trial that will provide important information on the laparoscopic repair of an incisional hernia; 1) with fascial closure, 2) with an IPOM mesh and 3) comparing the use of an articulating mesh-fixation device that deploys absorbable tacks with a straight-arm mesh-fixation device that deploys non-absorbable tacks.

Methods: A prospective, single-centre, double-blinded randomised trial, TACKoMESH, will establish whether the use of absorbable compared to non-absorbable tacks in adult patients undergoing elective incisional hernia repair produces a lower rate of pain both immediately and long-term. Eligible and consenting patients will be randomized to surgery with one of two tack-fixation devices and followed up for a minimum one year. Secondary outcomes to be explored include wound infection, seroma formation, hernia recurrence, length of postoperative hospital stay, reoperation rate, operation time, health related quality of life and time to return to normal daily activity.

Discussion: With ongoing debate around the best management of incisional hernia, continued trials that will add substance are both necessary and important. Laparoscopic techniques have become established in reducing hospital stay and rates of infection and report improvement in some patient centered outcomes whilst achieving similarly low rates of recurrence as open surgical techniques. The laparoscopic method with tack fixation has developed a reputation for its tendency to cause post-operative pain. Novel additions to technique, such as intraoperative-sutured closure of a fascial defect, and developments in surgical technology, such as the evolution of composite mesh design and mesh-fixation devices, have brought about new considerations for patient and surgeon. This study will evaluate the efficacy of several new technical considerations in the setting of elective laparoscopic incisional hernia repair.

Trial registration: Name of registry - ClinicalTrials.gov Registration number: NCT03434301 . Retrospectively registered on 15th February 2018.

Keywords: Absorbable tacks; Closure of the fascial defect; Fascial closure; Intraperitoneal onlay mesh; Laparoscopic incisional hernia repair; ReliaTackTM; SymbotexTM composite mesh.

Conflict of interest statement

Ethics approval and consent to participate

The full study protocol was peer reviewed by Mr. Andrew deBeaux, president of the British hernia society and consultant surgeon, Edinburgh Royal Infirmary as well as Mr. Andrew Macdonald, consultant Surgeon, Glasgow Royal Infirmary. TACKoMESH has ethics approval from the National Health Service Regional Ethics committee (Ref: 17/NW/0082). Results will be disseminated to healthcare professionals and presented at both local and international academic meetings and may be used to design other definitive trials based on evolving tack technology.

Chosen absorbable and non-absorbable tack fixation devices, will be used within their licensed indication, therefore this study does not require a Clinical Trials Authorisation from the MHRA. The study will be conducted in accordance with the Research Governance Framework for Health and Social Care, Second edition (2005). The study will be sponsored by Manchester University NHS Foundation Trust (MFT) and has been approved by the Local Manchester Research Ethics Committee, registered with the Health Research Authority (HRA) and the MFT R&D department (IRAS number 213428) (REC Ref: 17/NW/0082). The Sponsor (MFT) has drawn up an agreement with the CI regarding study responsibilities, which will be signed by the appropriate personnel.

The trial will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with good clinical practice. Any amendments to the protocol will be submitted to the REC as appropriate.

A Trial Steering Committee (TSC) and an independent Data Monitoring Committee (DMC) board will be convened. The first meeting of the TSC & DMC will consider the need for formal interim efficacy and/or safety analyses (including all study arms). A minimum of 20% data will be audited. The TSC & DMC will provide monitoring to assure the well-being of the patients on an ongoing basis and as such may recommend early termination of the study because of ethical or safety reasons. It will also serve as an independent data monitoring committee to review the results before establishing the final report.

The UK MFT may conduct site inspections and audits to ensure the study is being carried in line with the appropriate regulations, Trust policies and SOPs. All trial investigators will have to have undergone Good Clinical Practice (GCP) training prior to participating in the study.

Consent for publication

No patient identifiable information or data included in this submission.

Competing interests

AS has given talks and attended advisory boards for Medtronic but never for incisional hernia repairs with the use of Symbotex and/or Reliatac™.

JJP is funded by the grant from Medtronic.

All other authors declare that they have no competing interests.

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