Protocol for Randomised Controlled Feasibility Study Comparing Cruroplasty with Circumferential DynaMesh-HIATUS® Versus Suture-Only Repair for Large Hiatus Hernias

Abstract

Laparoscopic fundoplication has become a standard surgical treatment for gastro-oesophageal reflux disease. Many of these patients also have a hiatus hernia that is repaired at the same time. However, suture-only repair of larger hiatus hernias has recurrence rates as high as 50%. Evidence on the effectiveness and safety of surgical mesh to reinforce hiatal repair compared with suture-only repair is currently lacking. This study aims to assess the feasibility of running a randomised controlled trial comparing the results of large hiatus hernia repair with DynaMesh-HIATUS® crural reinforcement versus standard suture repair alone. This is a single-centre, double-blind, parallel group randomised feasibility study. Forty patients with large hiatus hernia will be randomised to standard laparoscopic suture repair or suture repair with cruroplasty using the DynaMesh-HIATUS® circumferential mesh, with a 3-year follow-up period. Participants and assessors will be blinded to treatment allocation. Outcomes include trial process indicators (eligible participants, recruitment, and retention rates), surgical indicators (placement of mesh, operative complications, length of stay), adverse events, patient quality of life and symptom scores and mesh position after 1 year, and patient quality of life measures to 3 years. Feasibility will be assessed by rates of recruitment, retention, and successful surgical procedures. Clinical and patient-related outcomes for the two surgical methods will be described, and those most appropriate to include in a definitive trial identified. Correlation will be made between the position of the mesh on magnetic resonance imaging (MRI) and clinical outcomes. The DYNAMIC study will provide information to design and deliver a definitive randomised controlled trial of DynaMesh-HIATUS® cruroplasty compared with suture repair alone. https://doi.org/10.1186/ISRCTN76437720