Patient-reported Outcome Measure (PROM) Rand-36-item Health Survey for Gallstone Disease Patients Five Years Following Surgery: A Prospective Randomized Study

Abstract

Background/Aim: There are no studies assessing the long-term quality of life (QoL) following threedimensional laparoscopy cholecystectomy (3D-LC) in patients with cholelithiasis (Chole). Patients and Methods: A cohort of 200 patients with Chole were randomized into 3D-LC or minilaparotomy cholecystectomy (MC) groups. RAND-36 survey was performed before randomization, four weeks and five years postoperatively. Results: Similar postoperative five years RAND-36 scores were reported in the 3D-LC and MC groups. The MC and 3D-LC groups combined analysis, social functioning (SF, p=0.007), mental health (MH, p=0.001), role physical (RP, p<0.001) and bodily pain (BP, p<0.001) domains increased significantly. In comparison to the Finnish reference RAND-36 (FRR) scores, the scores at five years increased significantly in the MH domain, while four RAND-36 domains; Physical functioning (PF), general health (GH), RP, BP remained significantly lower in comparison to the FRR scores. Conclusion: A relatively similar long-term outcome in the 3D-LC and MC patients is shown. Interestingly, five RAND-36 domains increased during five years follow-up, while four RAND-36 domains remained lower than FRR scores, which may indicate onset of possible new symptoms following cholecystectomy in longterm follow-up.Cholelithiasis (Chole) and cholecystitis are among the most common diseases needing operative management worldwide with almost 18 million cholecystectomies (Ccy) performed every year (1, 2). Most quality of life (QoL) reports following Ccy assess short-term outcomes including perioperative course, early complications, duration of hospital stay, morbidity and mortality, while, very few studies on long-term (QoL) are available, although many Ccy patients report continuous symptoms or appearance of new abdominal symptoms following Ccy (3-6). Therefore, long-term QoL of Ccy patients with the patient-reported outcome measures (PROMs) are important tools for assessing QoL from a patient's own experience. A lack of long-term evaluation with PROMs is also internationally recognized (3-9) and many national healthcare organizations such as National Institute for Health and Care Excellence (NICE) suggest feedback (10) from patients to enhance QoL and assess various treatment procedures. In addition, earlier studies of PROMs following Ccy strongly focus on surgical outcomes and little on the assessment of the Ccy patient's own experience (3-9). NICE recommends wider use of PROMs to report important outcomes, including the recurrence of symptoms and appearance of new symptoms that affect long-term QoL in patients undergoing Ccy (10). Recently, Saimanen et al. (11) assessed the 3-year QoL of Ccy patients using the RAND-36-Item Health Survey. A cohort of 110 Chole patients were randomized to minilaparotomy cholecystectomy (MC) or standard 2dimensional (2D) laparoscopic cholecystectomy (2D-LC). The RAND-36 survey was performed before randomization, four weeks, six months, and three years postoperatively. During follow-up, four RAND-36 domains 1213