Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair with Sutures Alone versus Sutures Reinforced with Mesh for Hiatus Hernia.

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. Previous studies evaluating lightweight polypropylene mesh (TiMesh®) for repair of hiatal hernia demonstrated good symptomatic and clinical outcome. However, recurrence rates in the long term are unknown.
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 (36 versus 36).



Study population:

Adult patients with proven hiatus hernia.



Intervention:

Patients will be randomized to undergo a laparoscopic primary repair with sutures alone or sutures augmented with prosthetic mesh.



Main study parameters/endpoints:

Integrity of the hiatal repair is the main endpoint. Secondary objectives include clinical recurrence of the hernia, development of post-operative reflux disease, postoperative side effects and overall 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 barium meal X-ray 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 20 years. Patients will undergo similar to standard post-operative follow-up and including barium meal X-ray and endoscopy at 3 months and 3 years after surgery.

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

Short- en longterm, 3 months and 3 years follow-up.

Patients will be randomized to undergo a laparoscopic primary repair with sutures alone or sutures augmented with prosthetic mesh.