Anterior Gastropexy for Paraesophageal Hernia Repair: A Randomized Clinical Trial.

Importance: Paraesophageal hernias can cause severe limitations in quality of life and life-threatening complications. Even though minimally invasive paraesophageal hernia repair (MIS-PEHR) is safe and effective, anatomic recurrence rates remain notoriously high. Retrospective data suggest that suturing the stomach to the anterior abdominal wall after repair-an anterior gastropexy-may reduce recurrence, but this adjunct is currently not the standard of care. Objective: To determine whether anterior gastropexy reduces 1-year recurrence after MIS-PEHR. Design, Setting, and Participants: This registry-based randomized clinical trial was conducted by 10 surgeons at 3 academic hospitals within the Cleveland Clinic Enterprise. Between June 26, 2019, and July 24, 2023, 348 patients were assessed for eligibility, and 240 patients were enrolled and randomized. Statistical analysis was performed from January to March 2024. Intervention: Enrolled patients were randomized to and received either an anterior gastropexy (n = 119) or no anterior gastropexy (n = 121). Main Outcome: The primary outcome was recurrence as determined by reherniation of the stomach greater than 2 cm above the diaphragm on routine imaging at 1 year or reoperation. Secondary outcomes included quality of life as measured by the Gastroesophageal Reflux Health-Related Quality of Life survey, additional foregut symptom questionnaire, and patient satisfaction at 30 days and 1 year. Results: A total of 240 patients were randomized to either anterior gastropexy (n = 119; 104 [97%] women; median [IQR] age, 70 [64-75] years) or no anterior gastropexy (n = 121; 97 [80%] women; median [IQR] age, 68 [62-73] years) at the end of their MIS-PEHR. At 1 year, 188 patients (78%) had completed follow-up. By intention-to-treat analysis, 1-year recurrence was significantly lower in patients who received an anterior gastropexy (15% vs 36%; risk difference, 0.21 [95% CI, 0.09-0.33]), which remained significant after risk-adjusted regression analysis (hazard ratio, 0.38 [95% CI, 0.23-0.60]). Of 13 reoperations (5.4%) for recurrence in the first year, 3 (2.5%) were in the anterior gastropexy group and 10 (8.2%) were in the no-gastropexy group (P = .052). Two patients (1.7%) had their anterior gastropexy sutures removed for pain. There were no significant differences in quality-of-life outcomes at 30 days and 1 year between treatment groups. Conclusions and Relevance: This randomized clinical trial found that the addition of an anterior gastropexy to MIS-PEHR is superior to no gastropexy in regard to reducing 1-year paraesophageal hernia recurrence. These results suggest that an anterior gastropexy should be routinely used in the context of minimally invasive paraesophageal hernia repair. Trial Registration: ClinicalTrials.gov Identifier: NCT04007952.