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Proposed randomised controlled feasibility trial of a novel polyvinylideneflouride (PVDF) mesh (Dynamesh®-HIATUS) cruroplasty versus suture-only repair of large hiatus hernia: the DYNAMIC Study

Research output: Contribution to journalMeeting Abstract

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Proposed randomised controlled feasibility trial of a novel polyvinylideneflouride (PVDF) mesh (Dynamesh®-HIATUS) cruroplasty versus suture-only repair of large hiatus hernia: the DYNAMIC Study. / Toh, S.; Knight, B.; Fogg, C.; Baddesley, E.; Higginson, A.; Beable, R.; Babu, S.; Hawes, E.; Moon, M.; Shoebridge, J.; Meredith, P.; Amos-Lyons, M.; May-Miller, P.

In: International Journal of Surgery, Vol. 59, 01.12.2018, p. S4.

Research output: Contribution to journalMeeting Abstract

Harvard

Toh, S, Knight, B, Fogg, C, Baddesley, E, Higginson, A, Beable, R, Babu, S, Hawes, E, Moon, M, Shoebridge, J, Meredith, P, Amos-Lyons, M & May-Miller, P 2018, 'Proposed randomised controlled feasibility trial of a novel polyvinylideneflouride (PVDF) mesh (Dynamesh®-HIATUS) cruroplasty versus suture-only repair of large hiatus hernia: the DYNAMIC Study' International Journal of Surgery, vol. 59, pp. S4. https://doi.org/10.1016/j.ijsu.2018.10.013

APA

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Author

Toh, S. ; Knight, B. ; Fogg, C. ; Baddesley, E. ; Higginson, A. ; Beable, R. ; Babu, S. ; Hawes, E. ; Moon, M. ; Shoebridge, J. ; Meredith, P. ; Amos-Lyons, M. ; May-Miller, P. / Proposed randomised controlled feasibility trial of a novel polyvinylideneflouride (PVDF) mesh (Dynamesh®-HIATUS) cruroplasty versus suture-only repair of large hiatus hernia: the DYNAMIC Study. In: International Journal of Surgery. 2018 ; Vol. 59. pp. S4.

Bibtex

@article{aedd9886ace8409a9aadab8df5c28d98,
title = "Proposed randomised controlled feasibility trial of a novel polyvinylideneflouride (PVDF) mesh (Dynamesh{\circledR}-HIATUS) cruroplasty versus suture-only repair of large hiatus hernia: the DYNAMIC Study",
abstract = "Background - Gastro-oesophageal reflux disease (GORD) is a significant health problem affecting up to 25{\%} of adults. Keyhole surgical treatment of chronic GORD has become an alternative to medical treatment over the past 20 years. However, patients with large hiatus hernias more than 5cm in size appear to have poorer results with recurrence in up to half of the patients. The use of mesh reinforcement has been considered to improve this, as this has been efficacious in other hernia repairs. However, with hiatal hernia repair there have been concerns about risks of mesh erosion and infection, and results to date have been equivocal.Aim - A feasibility randomised controlled trial (RCT) comparing suture versus mesh+suture repair (with blinded patient and assessor) for large hiatus hernias more than 5cm.Methods - This feasibility study utilises a novel permanent synthetic circumferential mesh tailored specifically for hiatal hernia repair. The material PVDF is unique with less risk of shrinkage or erosion. It is MRI visible uniquely allowing study of its position in vivo. Forty patients will be randomised in theatre with outcome data to 3 years including GERD-QOL, EQ50, evidence of recurrent reflux or hiatus hernia on barium swallow, and utilising a new classification of mesh position on MRI correlating this to outcome.This study will commence in November 2018 with recruitment phase over one year, and follow-up to three years. A multidisciplinary team including academics, patients and clinicians have produced a new protocol that sets the standard for future RCTs in hiatal hernia surgery.",
author = "S. Toh and B. Knight and C. Fogg and E. Baddesley and A. Higginson and R. Beable and S. Babu and E. Hawes and M. Moon and J. Shoebridge and P. Meredith and M. Amos-Lyons and P. May-Miller",
year = "2018",
month = "12",
day = "1",
doi = "10.1016/j.ijsu.2018.10.013",
language = "English",
volume = "59",
pages = "S4",
journal = "International Journal of Surgery",
issn = "1743-9191",

}

RIS

TY - JOUR

T1 - Proposed randomised controlled feasibility trial of a novel polyvinylideneflouride (PVDF) mesh (Dynamesh®-HIATUS) cruroplasty versus suture-only repair of large hiatus hernia: the DYNAMIC Study

AU - Toh, S.

AU - Knight, B.

AU - Fogg, C.

AU - Baddesley, E.

AU - Higginson, A.

AU - Beable, R.

AU - Babu, S.

AU - Hawes, E.

AU - Moon, M.

AU - Shoebridge, J.

AU - Meredith, P.

AU - Amos-Lyons, M.

AU - May-Miller, P.

PY - 2018/12/1

Y1 - 2018/12/1

N2 - Background - Gastro-oesophageal reflux disease (GORD) is a significant health problem affecting up to 25% of adults. Keyhole surgical treatment of chronic GORD has become an alternative to medical treatment over the past 20 years. However, patients with large hiatus hernias more than 5cm in size appear to have poorer results with recurrence in up to half of the patients. The use of mesh reinforcement has been considered to improve this, as this has been efficacious in other hernia repairs. However, with hiatal hernia repair there have been concerns about risks of mesh erosion and infection, and results to date have been equivocal.Aim - A feasibility randomised controlled trial (RCT) comparing suture versus mesh+suture repair (with blinded patient and assessor) for large hiatus hernias more than 5cm.Methods - This feasibility study utilises a novel permanent synthetic circumferential mesh tailored specifically for hiatal hernia repair. The material PVDF is unique with less risk of shrinkage or erosion. It is MRI visible uniquely allowing study of its position in vivo. Forty patients will be randomised in theatre with outcome data to 3 years including GERD-QOL, EQ50, evidence of recurrent reflux or hiatus hernia on barium swallow, and utilising a new classification of mesh position on MRI correlating this to outcome.This study will commence in November 2018 with recruitment phase over one year, and follow-up to three years. A multidisciplinary team including academics, patients and clinicians have produced a new protocol that sets the standard for future RCTs in hiatal hernia surgery.

AB - Background - Gastro-oesophageal reflux disease (GORD) is a significant health problem affecting up to 25% of adults. Keyhole surgical treatment of chronic GORD has become an alternative to medical treatment over the past 20 years. However, patients with large hiatus hernias more than 5cm in size appear to have poorer results with recurrence in up to half of the patients. The use of mesh reinforcement has been considered to improve this, as this has been efficacious in other hernia repairs. However, with hiatal hernia repair there have been concerns about risks of mesh erosion and infection, and results to date have been equivocal.Aim - A feasibility randomised controlled trial (RCT) comparing suture versus mesh+suture repair (with blinded patient and assessor) for large hiatus hernias more than 5cm.Methods - This feasibility study utilises a novel permanent synthetic circumferential mesh tailored specifically for hiatal hernia repair. The material PVDF is unique with less risk of shrinkage or erosion. It is MRI visible uniquely allowing study of its position in vivo. Forty patients will be randomised in theatre with outcome data to 3 years including GERD-QOL, EQ50, evidence of recurrent reflux or hiatus hernia on barium swallow, and utilising a new classification of mesh position on MRI correlating this to outcome.This study will commence in November 2018 with recruitment phase over one year, and follow-up to three years. A multidisciplinary team including academics, patients and clinicians have produced a new protocol that sets the standard for future RCTs in hiatal hernia surgery.

U2 - 10.1016/j.ijsu.2018.10.013

DO - 10.1016/j.ijsu.2018.10.013

M3 - Meeting Abstract

VL - 59

SP - S4

JO - International Journal of Surgery

T2 - International Journal of Surgery

JF - International Journal of Surgery

SN - 1743-9191

ER -

ID: 12739805