JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Improvement in the quality of life following cholecystectomy: a randomized multicenter study of health status (RAND-36) in patients with laparoscopic cholecystectomy versus minilaparotomy cholecystectomy.

PURPOSE: The assessment of the quality of life (QoL) in minilaparotomy cholecystectomy (MC) versus laparoscopic cholecystectomy (LC) with the ultrasonic dissection in both groups has not been addressed earlier.

METHODS: Initially, 109 patients with non-complicated symptomatic gallstone disease were randomized to undergo either MC (n = 59) or LC (n = 50). RAND-36 survey was conducted preoperatively and at 4 weeks and 6 months postoperatively. The end point of our study was to determine differences in health status in MC versus LC groups.

RESULTS: QoL improved significantly in both groups, and the recovery was similar in the two groups, except from the higher score in 'health change' subscale at 4 weeks in MC group [MC score 75.0 (25.0) vs. LC score 56.5 (23.2), p = 0.008]. The MC and LC groups combined, RAND-36 scores increased significantly in 'physical functioning' [combined mean (SD) preoperative score 80.5 (23.9) vs. 6-month postoperative score 86.5 (21.7), p = 0.015], 'vitality' [64.5 (19.2) vs. 73.5 (18.3), p = 0.001], 'health change' [43.0 (21.6) vs. 74.6 (25.4), p = 0.0001] and 'bodily pain' scores [57.7 (26.3) vs. 75.5 (25.5), p = 0.001], respectively. Four RAND-36 domains indicated statistically significant health status differences in comparing the preoperative and postoperative RAND-36 scores in LC and MC groups combined.

CONCLUSIONS: Four RAND-36 domains indicated a significant positive change in QoL after cholecystectomy.

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