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 three-dimensional 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 long-term follow-up.

Keywords: 3D Laparoscopy; Cholelithiasis; RAND-36; cholecystectomy; long-term outcome.