Objective To determine the relative benefits and risks of laparoscopic fundoplication surgery as an alternative to long term drug treatment for chronic gastro- oesophageal reflux disease ( GORD).
Design Multicentre, pragmatic randomised trial ( with parallel preference groups).
Setting 21 hospitals in the United Kingdom.
Participants 357 randomised participants ( 178 surgical, 179 medical) and 453 preference participants ( 261, 192); mean age 46; 66% men. All participants had documented evidence of GORD and symptoms for > 12 months.
Intervention The type of laparoscopic fundoplication used was left to the discretion of the surgeon. Those allocated to medical treatment had their treatment reviewed and adjusted as necessary by a local gastroenterologist, and subsequent clinical management was at the discretion of the clinician responsible for care.
Main outcome measures The disease specific REFLUX quality of life score ( primary outcome), SF- 36, EQ- 5D, and medication use, measured at time points equivalent to three and 12 months after surgery, and surgical complications.
Main results Randomised participants had received drugs for GORD for median of 32 months before trial entry. Baseline REFLUX scores were 63.6 ( SD 24.1) and 66.8 ( SD 24.5) in the surgical and medical randomised groups, respectively. Of those randomised to surgery, 111 ( 62%) actually had total or partial fundoplication. Surgical complications were uncommon with a conversion rate of 0.6% and no mortality. By 12 months, 38% ( 59/ 154) randomised to surgery ( 14% ( 14/ 104) among those who had fundoplication) were taking reflux medication versus 90% ( 147/ 164) randomised medical management. The REFLUX score favoured the randomised surgical group ( 14.0, 95% confidence interval 9.6 to 18.4; P< 0.001). Differences of a third to half of 1 SD in other health status measures also favoured the randomised surgical group. Baseline scores in the preference for surgery group were the worst; by 12 months these were better than in the preference for medical treatment group.
Conclusion At least up to 12 months after surgery, laparoscopic fundoplication significantly increased measures of health status in patients with GORD.
Trial registration ISRCTN15517081.
- proton-pump inhibitors
- laparoscopic nissen fundoplication