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. 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), S4. (doi:10.1016/j.ijsu.2018.10.013).

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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Contributors

Author: C. Fogg

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