Abstract
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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Acknowledgements
The study was funded by the Heikki, Aino and Aarne Korhonen foundation and the EVO funding of the Helsinki University Hospital and Kuopio University Hospital. The authors would like to thank the patients for their participation in the study.
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The authors declare that they have no conflict of interest.
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The study was approved by the Ethics Committee of Helsinki and Uusimaa University District, Helsinki, Finland (DNRO 120/13/02/02/2010, May 12, 2010), and it was registered in the ClinicalTrials.gov database (ClinicalTrials.gov Identifier: NCT01723540, Consort diagram, Fig. 1).
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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Aspinen, S., Kärkkäinen, J., Harju, J. et al. 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. Qual Life Res 26, 665–671 (2017). https://doi.org/10.1007/s11136-016-1485-1
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DOI: https://doi.org/10.1007/s11136-016-1485-1