Surgical Repair of Primary Paraesophageal Hernias Comparing Standard Treatment With Added Gastropexy to Improve Outcomes

What this Trial Is About

Researchers are evaluating the effectiveness of adding gastropexy to conventional surgical repair for patients with primary paraesophageal hernias. This randomized, triple-blind clinical trial compares standard crural repair combined with a Nissen fundoplication against the same procedure with an additional three-point gastropexy. The study aims to determine if the gastropexy improves outcomes in hernia repair. Participants are divided into two groups the control group receives standard paraesophageal hernia repair, which includes crural suturing and a total Nissen fundoplication. The interventional group receives the same standard repair plus a gastropexy, which involves fixing parts of the stomach wrap to the diaphragm and abdominal wall using sutures. The study includes preoperative and postoperative imaging with CT scans at baseline, 1 year, and 3 years after surgery to assess anatomical results. Participants will complete several questionnaires before surgery and at 3 months, 1 year, and 3 years post-surgery to assess quality of life, gastrointestinal symptoms, reflux frequency, and swallowing difficulties. Outcomes include hernia recurrence at 1 and 3 years, surgical complications, hospital stay length, and patient-reported symptom changes. The total follow-up period extends to 3 years with regular assessments to monitor safety and efficacy.

Gastropexy in the Repair of Patients with Paraesophageal Hernias