Total versus partial posterior fundoplication in the surgical repair of para-oesophageal hernias: randomized clinical trial.

BACKGROUND: Fundoplication is an essential step in para-oesophageal hernia (POH) repair, but which type minimizes postoperative mechanical complications is controversial. METHODS: This was a randomized, double-blind clinical trial conducted between May 2009 and October 2018. Patients with symptomatic POH were allocated to either a total (Nissen) or a posterior partial (Toupet) fundoplication after hernia reduction and crural repair. The primary outcome was dysphagia (Ogilvie dysphagia scores) at 6 months postoperatively. Secondary outcomes were peri- and postoperative complications, swallowing difficulties assessed by the Dakkak dysphagia score, gastro-oesophageal reflux, quality of life (QoL), and radiologically confirmed hernia recurrence. RESULTS: A total of 70 patients were randomized to a Nissen (n = 32) or a Toupet (n = 38) fundoplication. Compared with baseline, Ogilvie dysphagia scores were stable at the 3- and 6-month follow-up in the Nissen group (P = 0.075 and 0.084 respectively) but significantly improved in the Toupet group (from baseline mean (s.d.): 1.4 (1.1) to 0.5 ( 0.8) at 3 months, and 0.5 (0.6) at 6 months; P = 0.003 and P = 0.001 respectively). At 6 months, Dakkak dysphagia scores were significantly higher in the Nissen group than in the Toupet group (mean (s.d.): 10.4 (7.9) versus 5.1 (7.2); P = 0.003). QoL scores improved throughout the follow-up. However, at 3 and 6 months postoperatively, the absolute median improvement (⍙) from preoperative values in the mental component scores of the Short Form-36 QoL questionnaire was significantly higher in the Toupet group (median (i.q.r.): 7.1 (-0.6 to 15.2) versus 1.0 (-5.4 to 3.3) at 3 months, and 11.2 (1.4 to 18.3) versus 0.4 (-9.4 to 7.5) at 6 months; (P = 0.010 and 0.003 respectively)). At 6 months, radiologically confirmed POH recurrence occurred in 11 of 24 patients (46 per cent) of the Nissen group and in 15 of 32 patients (47 per cent) of the Toupet group (P = 1.001). CONCLUSIONS: A partial posterior wrap (Toupet fundoplication) showed reduced obstructive complications and improved QoL compared with a total (Nissen) fundoplication following POH repair.Registration number: NCT04436159 (http://www.clinicaltrials.gov).