Randomized Controlled Trial of Laparoscopic Primary Crural Repair versus Primary Repair with Circular Bio-absorbable Hiatal Mesh Reinforcement in Hiatal Hernia Repair

Rationale: Laparoscopic hiatus hernia repair is associated with a high recurrence rate. Repair reinforced with mesh lowers short-term recurrence but can cause dysphagia and visceral erosion. Results of the PRIME trial, in which non-absorbable mesh reinforcement of the posterior cruroplasty was investigated, showed equal recurrence compared to primary repair after 6 months. It is hypothesized that circular absorbable MESH reinforcement of the hiatus could reduce recurrence rate.

Objective: To define the optimum laparoscopic hiatus hernia repair, ensuring long-term effect with minimal postoperative side effects.

Study design: Prospective blinded randomized controlled superiority trial comparing two laparoscopic procedures for hiatus hernia repair (110 versus 110).

Study population: Adult patients with proven hiatus hernia type II-IV (defined by preoperative CT-scan).

Intervention: Patients will be randomized to undergo a laparoscopic primary crural repair with sutures alone or suture repair augmented with prosthetic absorbable, circular mesh at the hiatus.

Main study parameters/endpoints: Radiologic integrity of the hiatal repair is the main endpoint. Secondary objectives are clinical recurrence of the hernia, development of post-operative reflux disease, postoperative side effects and satisfaction with surgical outcome.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Preoperatively included patients will undergo an endoscopy and CT scan according to standard clinical practice. Questionnaires will be filled in pre-operatively and at 3, 6, 12 months post-operatively and then yearly for up to 10 years. Patients will undergo similar to standard post-operative follow-up and including CT-scan at 3 months and 1 and 5 years after surgery.

Bio-aborbable circular mesh reinforcement of the hiatus reduces recurrence rate after hiatal hernia repair.

3 months postoperatively

3 years postoperatively

1. Laparoscopic primary hiatal hernia repair and 180 degrees fundoplication.

2. Laparoscopic primary hiatal repair with circular bio-absorbable mesh reinforcement and 180 degrees fundoplication.