Hiatus hernia, Mesh repair, Laparoscopy, Randomized controlled trial.
Trial registration -This trial is registered with the Australia and New Zealand ClinicalTrials Registry ACTRN12605000725662 Determine whether absorbable or non-absorbable mesh in repair of large hiatus hernias reduces the risk of recurrence, compared to suture repair.
Summary Background Data:Repair of large hiatus hernia is associated with radiological recurrence rates of up to 30%, and to improve outcomes mesh repair has been recommended. Previous trials have shown less short term recurrence with mesh, but adverse outcomes limit mesh use.
Methods:Multicentre prospective double blind randomized controlled trial of 3 methods of repair; sutures vs. absorbable mesh vs. non-absorbable mesh. Primary outcome -hernia recurrence assessed by barium meal X-ray and endoscopy at 6 months. Secondary outcomes -clinical symptom scores at 1, 3, 6 and 12 months.
Results:126 patients enrolled -43 sutures, 41 absorbable mesh and 42 non-absorbable mesh. 96.0%were followed to 12 months, with objective follow-up data in 92.9%. A recurrent hernia (any size) was identified in 23.1% following suture repair, 30.8% -absorbable mesh, and 12.8%