Randomized clinical trial of laparoscopic Nissen fundoplication compared with proton-pump inhibitors for treatment of chronic gastro-oesophageal reflux.

Both laparoscopic Nissen fundoplication (LNF) and proton-pump inhibitor (PPI) therapy are established in the treatment of gastro-oesophageal reflux disease (GORD). The aim of this study was to compare these two treatments in a randomized clinical trial. Between July 1997 and August 2001, 340 patients with a history of GORD for at least 6 months were investigated by endoscopy, 24-h pH monitoring and manometry. Of these, 217 were randomized, 109 to LNF and 108 to PPI therapy. The two groups were well matched for age, sex, weight and severity of reflux. Twenty-four-hour pH monitoring and manometry were performed 3 months after treatment, and quality of life was assessed in both groups using the Psychological General Well-being Index and the Gastrointestinal Symptom Rating Scale at 3 and 12 months after treatment. At 3 months there was an improvement in lower oesophageal sphincter pressure from 6.3 to 17.2 mmHg in the LNF group but no change in the PPI group (8.1 and 7.9 mmHg before and after treatment respectively) (P < 0.001). The mean DeMeester acid exposure score improved from 42.7 to 8.6 (P < 0.001) in the LNF group and from 36.9 to 17.7 in the PPI group (P < 0.001). The mean gastrointestinal symptom and general well-being scores improved from 31.7 and 95.4 respectively before treatment to 37.0 and 106.2 at 12 months after LNF, compared with changes from 34.3 and 98.5 to 35.0 and 100.4 respectively in the PPI group. The differences in both of these scores were significant between the two groups at 12 months (P = 0.003). LNF leads to significantly less acid exposure of the lower oesophagus at 3 months and significantly greater improvements in both gastrointestinal and general well-being after 12 months compared with PPI treatment.

Mahon D ，Rhodes M ，Decadt B ，Hindmarsh A ，Lowndes R ，Beckingham I ，Koo B ，Newcombe RG ... -  《BRITISH JOURNAL OF SURGERY》

Short-term cost effectiveness and long-term cost analysis comparing laparoscopic Nissen fundoplication with proton-pump inhibitor maintenance for gastro-oesophageal reflux disease.

This study examined the short-term cost-effectiveness and long-term cost of laparoscopic Nissen fundoplication (LNF) versus maintenance proton-pump inhibitor (PPI) medication for severe gastro-oesophageal reflux disease (GORD) based on a randomized clinical trial. Costs and outcomes for 12 months were obtained from the first 100 patients in the trial. Detailed costing was performed using resource use data from hospital records and general practitioners' notes. Short-term incremental cost-effectiveness ratios, calculated as the cost difference divided by the effectiveness difference between LNF and PPI therapy, were analysed using net benefit and bootstrap approaches. Long-term cost was examined using sensitivity analyses incorporating published data from other large series. The incremental cost of LNF compared with PPI therapy per additional patient returned to a physiologically normal acid score (less than 13.9) at 3 months was pound5515 (95 per cent confidence interval (c.i.) pound3655 to pound13 400) and the incremental cost per point improvement in combined Gastro-Intestinal and Psychological Well-being score at 12 months was pound293 (90 per cent c.i. pound149 to pound5250). On average, LNF cost pound2247 (95 per cent c.i. pound2020 to pound2473) more than PPI therapy in year 1 and broke even in year 8. Break-even was highly sensitive to hospital unit costs but less sensitive to PPI ingestion rate after LNF, LNF reoperation rate, PPI relapse rate, future PPI price, PPI dose escalation and discount rate. From a National Health Service perspective, LNF may be cost-saving after 8 years compared with maintenance PPI therapy for the treatment of GORD.

Cookson R ，Flood C ，Koo B ，Mahon D ，Rhodes M ... -  《BRITISH JOURNAL OF SURGERY》

Ten-year outcome of laparoscopic and conventional nissen fundoplication: randomized clinical trial.

Broeders JA ，Rijnhart-de Jong HG ，Draaisma WA ，Bredenoord AJ ，Smout AJ ，Gooszen HG ... -  《-》

Randomized clinical trial of standard laparoscopic versus robot-assisted laparoscopic Nissen fundoplication for gastro-oesophageal reflux disease.

Draaisma WA ，Ruurda JP ，Scheffer RC ，Simmermacher RK ，Gooszen HG ，Rijnhart-de Jong HG ，Buskens E ，Broeders IA ... -  《BRITISH JOURNAL OF SURGERY》

Combined multichannel intraluminal impedance-pH monitoring to select patients with persistent gastro-oesophageal reflux for laparoscopic Nissen fundoplication.

Mainie I ，Tutuian R ，Agrawal A ，Adams D ，Castell DO ... -  《-》