Randomized clinical trial and follow-up study of cost-effectiveness of laparoscopic versus conventional Nissen fundoplication

Abstract

Background: Laparoscopic Nissen fundoplication (LNF) has essentially replaced its conventional open counterpart (CNF). An economic evaluation of LNF compared with CNF based on prospective data with adequate follow-up is lacking.Methods: Data from two consecutive studies (a randomized clinical trial (RCT) of 57 patients undergoing LNF and 46 undergoing CNF that was terminated prematurely, and a follow-up study of 121 consecutive patients with LNF) were combined to determine incremental cost-effectiveness 1 year after surgery.Results: Mean operating time, reoperation rate and hospital costs of LNF were lower in the second series. The mean overall hospital cost per patient was ¤9126 for LNF and ¤6989 for CNF at 1 year in the initial RCT, and ¤7782 in the second LNF series. The success rate of both LNF and CNF at 1 year was 91 per cent in the RCT, and LNF was successful in 90·1 per cent in the second series. A cost reduction of ¤998 for LNF would cancel out the cost advantage of CNF. Similarly, if the reoperation rate after LNF decreased from 0·05 to below 0·008 and/or if the mean duration of sick leave after LNF was reduced from 67·2 to less than 61·1 days, the procedure would become less expensive than CNF. Complications, reoperation rate and quality of life after both operations were similar. Conclusion:Including reinterventions, the outcome at 1 year after LNF and CNF was similar. In a well organized setting with appropriate expertise, the cost advantage of CNF may be neutralized.

Health economic evaluation of therapeutic strategies in patients with idiopathic achalasia: results of a randomized trial comparing pneumatic dilatation with laparoscopic cardiomyotomy

“…The results are interesting and are also somewhat expected based on recent data from a neighboring clinical research field, i.e., gastroesophageal reflux disease. Despite a somewhat smoother postoperative course after a laparoscopic operation, it has been found to be notoriously difficult to show a competitive cost-efficacy profile compared to an open procedure [21]. This is mainly because of the higher costs associated with the actual laparoscopic procedure in the form of longer operating time, costly equipment, and disposable instruments.…”

Impact of symptom–reflux association analysis on long-term outcome after Nissen fundoplication

“…All surgeons who participated in the RCT 12 had gone through the learning curve, defined by Watson and colleagues 15 as more than five fundoplications by an experienced laparoscopic surgeon and over 20 procedures by a less experienced laparoscopic surgeon. Subsequent patients underwent fundoplication by surgeons with experience of more than 30 laparoscopic fundoplications 13,14 .…”

A meta-analysis of outcomes after open and laparoscopic Nissen's fundoplication in the treatment for gastro-oesophageal reflux disease

“…Sixteen studies [13,14,19,[23][24][25][26][27][28][29][30][31][32][33][34][35] on nine randomized controlled trials comparing LNF with ONF were retrieved from the electronic databases and included in our study according to our inclusion criteria (Table 1). Three trials [12,17,36] were excluded ( Table 2).…”

“…Six trials [13,23,[25][26][27][28][29][30][31][32][33][34][35] investigated overall morbidity and no significant heterogeneity existed between trials …”