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

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.

First RAND-36-Item Health Survey in Three-dimensional Laparoscopy Cholecystectomy: A Prospective Randomized Study.

BACKGROUND/AIM: National healthcare organizers require feedback from patients to improve medical treatment methods. Three-dimensional laparoscopy cholecystectomy (3D-LC) is a modern technique in surgery. However, there are no studies with patient feedback from validated questionnaires assessing the postoperative treatment results in 3D-LC. PATIENTS AND METHODS: Initially 200 patients with symptomatic cholelithiasis were randomized into 3D-LC or mini-laparotomy cholecystectomy (MC) groups. RAND-36-Item Health Survey was performed preoperatively and 4 weeks following surgery relating the survey scores between the 3D-LC and MC groups. RESULTS: Similar postoperative RAND-36 scores were reported for both groups preoperatively and at 4 weeks following surgery, and no significant differences in RAND-36 domains were shown. When the patients in both study groups were combined, Mental Health (p<0.001), Bodily Pain (p=0.01) and General Health (p=0.016) domain scores were significantly higher, indicating a significantly positive change in quality of life 4 weeks postoperatively, while those for the Role-Physical domain were significantly lower, indicating reduced physical activity during the 4 weeks following surgery. In comparison to the Finnish reference RAND-36 scores, scores at 4 weeks were significantly higher for the Mental Health domain (MC group, p<0.001 and 3D-LC group, p=0.001) whilst scores were significantly lower in four other domains: Physical Functioning, Social Functioning, Bodily Pain and Role-Physical. CONCLUSION: This study shows, for the first time using the RAND-36-Item Health Survey, relatively similar short-term outcomes in patients 4 weeks following cholecystectomy by 3D-LC and MC. Although scores for three RAND-36 domains were significantly higher postoperatively, indicating a significantly positive change in quality of life, a longer follow-up after cholecystectomy is needed for final conclusions to be drawn.