Cost-effectiveness analysis of a multicentre randomized clinical trial comparing surgery with conservative management for recurrent and ongoing diverticulitis (DIRECT trial)

Abstract

Background:The results of the DIRECT trial, an RCT comparing conservative management with elective sigmoid resection in patients with recurrent diverticulitis or persistent complaints, showed that elective sigmoid resection leads to higher quality of life. The aim of this study is to determine the cost-effectiveness of surgical treatment at 1-and 5-year follow-up from a societal perspective. Methods: Clinical effectiveness and resource use were derived from the DIRECT trial. The actual resource use and quality of life (EQ-5D-3L™ score) were documented prospectively per individual patient and analysed according to the intention-to-treat principle for up to 5 years after randomization. The main outcome was the incremental cost-effectiveness ratio (ICER), expressed as costs per quality-adjusted life-year (QALY). Results: The study included 106 patients, of whom 50 were randomized to surgery and 56 to conservative treatment. At 1-and 5-year follow-up an incremental effect (QALY difference between groups) of 0⋅06 and 0⋅43 respectively was found, and an incremental cost (cost difference between groups) of €6957 and €2674 respectively, where surgery was more expensive than conservative treatment. This resulted in an ICER of €123 365 per additional QALY at 1-year follow-up, and €6275 at 5 years. At a threshold of €20 000 per QALY, operative treatment has 0 per cent probability of being cost-effective at 1-year follow-up, but a 95 per cent probability at 5 years. Conclusion: At 5-year follow-up, elective sigmoid resection in patients with recurring diverticulitis or persistent complaints was found to be cost-effective. Registration number: NTR1478 (www .trialregistrer.nl).

Evaluation of the Implementation of FDG-PET/CT and Staging Laparoscopy for Gastric Cancer in The Netherlands

“…To slightly elaborate on the costs, an FDG-PET/CT costs €1200 on average 24 and an SL costs €900 on average, based on the minute price of the operating room (including operating room, nurses, surgeon, anesthesiologist, overheads). 25 However, we await the results of the PLASTIC study in order to make statements on the economic aspects.…”

Changing Paradigms in the Management of Acute Uncomplicated Diverticulitis

“…Risk for stoma was 5%–21%, and severe complication requiring reoperation occurred in 10%–28% patients randomized to surgery arm ( 70 , 71 ). From an economical point of view and based on DIRECT trial data, elective sigmoid resection was also found to be cost-effective ( 74 ). Some limitations of the trials are worth mentioning.…”

Emerging evidence and recent controversies in diverticulitis: a 5-year review

“…The authors found a significant improvement in gastrointestinal quality of life in the resection group, and reported that a quarter of the patients in the conservative management group ended up opting for a resection by 6 months and nearly half at 5 years. Additionally, at 5 years, these improvements in quality of life may persist, and the elective resection approach may also be more cost effective [ 65 , 66 ]. A similar, more recent publication, the LASER trial of Finnish patients, published essentially identical findings from their own RCT [ 67 ].…”