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
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
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.
S4
Toh, S.
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Knight, B.
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Fogg, C.
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Baddesley, E.
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Higginson, A.
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Beable, R.
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Babu, S.
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Hawes, E.
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Moon, M.
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Shoebridge, J.
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Meredith, P.
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Amos-Lyons, M.
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May-Miller, P.
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1 December 2018
Toh, S.
faf8cf8c-8408-4d88-9e64-e964a15b3872
Knight, B.
8ca2d451-33e4-4d8d-a09e-1f1eef8f596f
Fogg, C.
42057537-d443-462a-8944-c804252c973b
Baddesley, E.
79d14440-34db-4924-ba5e-d281468e29ba
Higginson, A.
51218eb4-b2b4-4659-be10-a39700912fbe
Beable, R.
f0cdb40a-176d-4134-ba0e-17421082a9f3
Babu, S.
666c5339-345d-4bf1-b0f5-a0a04385b038
Hawes, E.
87284788-5e55-4438-997b-ca946526dbf2
Moon, M.
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Shoebridge, J.
a84fc761-6dcb-4137-9ca5-33a3de466bbd
Meredith, P.
25fd5f1c-f3ed-40a2-af59-5a7074a25fcd
Amos-Lyons, M.
ceedb006-c671-4e2d-8fed-bef1cf40603d
May-Miller, P.
19607b61-1b76-4bc6-9907-56afab4640cc
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. and 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, 59 (Supplement 1), .
(doi:10.1016/j.ijsu.2018.10.013).
Record type:
Meeting abstract
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.
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Published date: 1 December 2018
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Local EPrints ID: 437127
URI: http://eprints.soton.ac.uk/id/eprint/437127
ISSN: 1743-9191
PURE UUID: d5ae08c1-9e93-4a1e-a0a9-ed93347c4235
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Date deposited: 17 Jan 2020 17:35
Last modified: 17 Mar 2024 03:56
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Contributors
Author:
S. Toh
Author:
B. Knight
Author:
E. Baddesley
Author:
A. Higginson
Author:
R. Beable
Author:
S. Babu
Author:
E. Hawes
Author:
M. Moon
Author:
J. Shoebridge
Author:
P. Meredith
Author:
M. Amos-Lyons
Author:
P. May-Miller
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