Sheen, Aali J.
Pilkington, J. James
Baltatzis, Minas
Tyurkylmaz, Ahmed
Stathakis, Panagiotis
Jamdar, Saurabh
Siriwardena, Ajith K.
Funding for this research was provided by:
Medtronic (US)
Central Manchester University Hospitals NHS Foundation Trust
Article History
Received: 20 March 2018
Accepted: 28 June 2018
First Online: 11 July 2018
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.
: No patient identifiable information or data included in this submission.
: 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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