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Abstract Background The optimal approach to a paraoesophageal hernia (PEH) repair is unclear. Several steps during the procedure are still for discussion. Most surgeons dealing with PEH surgery agree on removal of the hernia sac from the mediastinum and a hiatoplasty with non-absorbable suture. Whether to perform an anti-reflux procedure or/and a gastropexy is unclear. Few studies exist on the subject but without clear favor of an anti-reflux procedure and/or a gastropexy. The aim of this upcoming study is to test if the anti-reflux procedure is redundant for patients suffering from PEH with obstructive rather than regurgitation symptoms. Methods We are setting up a pragmatic, prospective, multicentre, two-armed study. Study beginning June 2024. Sample size calculation with 108 patients in each arm. Both arms will do hernia sac excision, closure of hiatus and gastropexy. One arm will in addition do an anti-reflux procedure. Our objectives are 1) To assess safety of anterior gastropexy with and without fundoplication regarding peri- and postoperative complications. 2) To compare efficacy of anterior gastropexy with and without fundoplication regarding symptom control and clinical recurrence. 3) To assess health related quality of life pre- and post-surgery in patients treated with the two strategies for PEH. Results Our primary outcome is disease specific and health related quality of life before surgery and 3-6-12 months after surgery. Secondary outcomes are per- and post-operative complications according to the clavien-dindo score and radiological status/recurrence 12 months after surgery. Conclusion The study will add on to existing knowledge about essential technical steps of PEH surgery. Do the patients benefit from a fundoplication or is this potentially complicating procedure redundant regarding long-term symptom control.
Østerballe et al. (Sun,) studied this question.