Laparoscopic or conventional Nissen fundoplication for gastro-oesophageal reflux disease: randomised clinical trial

Background For the surgical treatment of gastrooesophageal reflux disease ( GORD), laparoscopic Nissen fundoplication has largely replaced the open pro cedure. Retrospective and prospective non-randomized studies have shown sim ilar results after laparoscopic Nissen fundoplication compared with the ope n procedure. Methods in a multicentre randomised trial candidates for surgical treatment of GORD were randomly assigned to either laparoscopic or open 360 degrees Nissen fundoplication. Primary endpoints were dysphagia, recurrent GORD, an d intrathoracic hernia. Secondary endpoints were effectiveness and quality of life. This planned interim analysis focuses on endpoints and complicatio ns and in-hospital costs. Findings At the time of interim analysis 11 patients in the laparoscopic gr oup and one in the conventional group had reached a primary endpoint (p=0.0 1; relative risk=8.8, 95% CI 1.2-66.3). This difference was caused mainly b y whether or not patients hd dysphagia (seven patients in the laparoscopic group and none in the conventional group p=0.016). Interpretation Although laparoscopic Nissen fundoplication was as effective as the open procedure in controlling reflux, the significantly higher risk of reaching a primary endpoint in the laparoscopic group led us to stop th e study.