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Randomized Controlled Trial Comparative Study
Long-Term Quality of Life after Minimally Invasive vs Open Distal Pancreatectomy in the LEOPARD Randomized Trial.
- Maarten Korrel, Anne Roelofs, Jony van Hilst, Olivier R Busch, Freek Daams, Sebastiaan Festen, Bas Groot Koerkamp, Joost Klaase, Misha D Luyer, Martijn G van Oijen, Irma M Verdonck-de Leeuw, Marc G Besselink, and LEOPARD Trial Collaborators.
- Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, The Netherlands.
- J. Am. Coll. Surg. 2021 Dec 1; 233 (6): 730-739.e9.
BackgroundMinimally invasive distal pancreatectomy (MIDP) shortens time to functional recovery and improves 30-day quality of life (QoL), as compared with open distal pancreatectomy (ODP) for nonmalignant disease. The impact of MIDP on QoL, cosmetic satisfaction, and overall major complications beyond 1-year follow-up is currently unknown.Study DesignThe Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD) trial randomized 108 patients to MIDP (laparoscopic or robotic) or ODP in 14 Dutch centers (April 2015 to March 2017). The primary outcome measure of this study was quality-adjusted life years (QALYs), as assessed with the EQ-5D. QoL was assessed using subscales of the EORTC QLQ-C30, PAN-26, and a body image questionnaire. The latter included a cosmetic satisfaction score (range 3-24), and a body image score (range 5-20). Differences between MIDP and ODP for QALYs, generic, and disease-specific QoL and body image were analyzed. Missing QoL data were imputed using multiple imputation.ResultsIn total, 84 patients were alive, with a median follow-up of 44 months; 62 of these patients (74%) completed the questionnaires (27 MIDP, 35 ODP). There was no significant difference in QALYs between the 2 groups (mean score 2.34 vs 2.46 years, p = 0.63), nor on the QoL subscales. Significant overall change in EQ-5D health utilities were found for both groups over time (p < 0.001). Patients in the MIDP group scored higher on cosmetic satisfaction (21 vs 14, p = 0.049). No differences between the 2 groups were observed for clinical outcomes such as major complications, readmissions, and incisional hernias.ConclusionsMore than 3 years after distal pancreatectomy, no improvement in QALYs and overall QoL was seen after MIDP, whereas cosmetic satisfaction was higher after MIDP as compared with ODP.Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.
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