Impact of diaphragmatic relaxing incision on one-year recurrence after paraesophageal hernia repair: a double-blind randomized trial

Abstract Introduction Surgical repair of paraesophageal hernias (PEH) is associated with high recurrence rates. Various reinforcement techniques have failed to improve durability, warranting exploration of alternative strategies. The aim of this trial was to investigate whether adding a left-sided diaphragmatic relaxing incision to standard crural repair and fundoplication reduces recurrence rates. Method In this double-blind, dual-centre randomized clinical trial, patients undergoing PEH repair between August 2019 and August 2023 were randomized to receive either standard crural repair (control) or crural repair in combination with a left-sided diaphragmatic relaxing incision at the upper pole of the spleen. After crural repair, the incision was covered with synthetic mesh. All patients underwent total fundoplication. The primary endpoint was CT-verified PEH recurrence at 12 months. Secondary outcomes included perioperative course, reflux, dysphagia, abdominal symptoms, and Quality of Life (QoL) at 3, 6, and 12 months. Outcomes were analyzed by intention-to-treat. Result Seventy-six patients were randomized (38 per group). Groups were well balanced. Two patients (one per group) died within 90 days postoperatively. At 12 months, PEH recurrence was found in 23/35 (66%) in the control group and 20/37 (54%) in the intervention group (p = 0.313). Both groups reported postoperative improvements in swallowing, reflux, indigestion, and abdominal pain. RAND-36 QoL scores improved, primarily in physical functioning, without differences between neither allocated groups nor patients with or without recurrence. Discussion Radiological recurrence remains high following standard laparoscopic PEH repair with fundoplication. Addition of a left-sided diaphragmatic relaxing incision does not reduce recurrence risk at one year.