None listed
Conditions
Brief summary
In a multicentre prospective double-blinded randomized trial, we will compare 3 laparoscopic methods for the repair of large hiatus hernia a) Repair using either sutures alone b) Repair with Biomesh (absorbable) c) Repair with Timesh (non-absorbable). to determine: 1) Short term and long term effectiveness of the hernia repair 2) Risk of postoperative side effects This trial will test the hypothesis that there is no difference in the incidence of recurrent hiatus hernia for the 3 different techniques of repair of large hiatus hernia. The primary outcome will be the integrity of the hiatal repair assessed by barium meal X-ray. Secondary outcomes will include clinical recurrence of the hernia, the development of post-operative reflux, the development of post-operative side effects, and overall satisfaction with the surgical outcome.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Large hiatus hernia (more than 50% of stomach in the chest)Laparoscopic surgical repair clinically indicatedFit for surgery.
Exclusion criteria
No informed consent.Previous surgery for gastro-oesophageal reflux or repair for hiatus herniaPregnant.