Randomized double-blind trial of laparoscopic Nissen fundoplication versus anterior partial fundoplication.

BACKGROUND: This double-blind, randomized study compared outcomes of laparoscopic Nissen total fundoplication and anterior partial fundoplication carried out by a single surgeon in a private practice.

METHODS: All patients with proven gastro-oesophageal reflux disease, regardless of motility, presenting for laparoscopic antireflux surgery were randomized to either Nissen total or anterior partial fundoplication. Primary outcome measures were dysphagia and abolition of reflux. Secondary outcome measures were Visick scores, bloating, patient satisfaction and reoperation rate.

RESULTS: Complete follow-up was available for 161 (98.8 per cent) of 163 patients (84 Nissen, 79 anterior). There were no differences in mean heartburn scores between groups. Recurrent reflux was observed in ten patients after anterior fundoplication, but none after the Nissen procedure. Dysphagia scores for both liquids and solids were lower after anterior fundoplication. Four patients had persistent troublesome dysphagia after Nissen fundoplication compared with none after anterior fundoplication. There were no differences between groups in postoperative bloating. The overall reoperation rate at 2 years was 7 per cent, all achieved laparoscopically.

CONCLUSION: Nissen fundoplication cured reflux in all patients up to 2 years, but 5 per cent required revisional surgery. Recurrent reflux was more common after anterior fundoplication, but dysphagia was rare. Patient satisfaction was excellent in both groups. Revisional laparoscopic surgery was safe and usually successful.