TY - JOUR
T1 - The Comprehensive Complication Index versus Clavien-Dindo grading after laparoscopic and open D2-gastrectomy in the multicenter randomized LOGICA-trial
AU - Triemstra, Lianne
AU - de Jongh, Cas
AU - Tedone, Fabrizio
AU - Brosens, Lodewijk A. A.
AU - Luyer, Misha D. P.
AU - Stoot, Jan H. M. B.
AU - Lagarde, Sjoerd M.
AU - van Hillegersberg, Richard
AU - Ruurda, Jelle P.
AU - Brenkman, Hylke J. F.
AU - van der Veen, Arjen
AU - Nieuwenhuijzen, Grard A. P.
AU - Ponten, Jeroen E. H.
AU - Tegels, Juul J. W.
AU - Hulsewe, Karel W. E.
AU - Wijnhoven, Bas P. L.
AU - Lanschot, Jan J. B.
AU - de Steur, Wobbe O.
AU - Hartgrink, Henk H.
AU - Kouwenhoven, Ewout A.
AU - van Det, Marc J.
AU - Wassenaar, Eelco B.
AU - van Duijvendijk, P.
AU - Draaisma, Werner A.
AU - Broeders, Ivo A. M. J.
AU - van der Peet, Donald L.
AU - the LOGICA Study Group
AU - Gisbertz, Suzanne S.
N1 - Funding Information: The authors sincerely thank all LOGICA-patients and everyone in the participating hospitals who contributed to the patient inclusions, data collection or by locally coordinating the LOGICA-trial. Furthermore, the authors would like to thank ZonMw (The Netherlands Organization for Health Research and Development) for financially supporting the LOGICA-trial, registered under project number 837002502 . An unrestricted educational grant to enable the proctoring of laparoscopic gastrectomy in participating centers before the start of the LOGICA-trial was supported by Johnson & Johnson , who the authors also would like to thank. Funding Information: No funding was received nor requested for this secondary analysis. The LOGICA-trial (NCT02248519) was funded by ZonMw (The Netherlands Organization for Health Research and Development) , project number 837002502 . The funder had no active role for the study or manuscript. Publisher Copyright: © 2023
PY - 2023/12/1
Y1 - 2023/12/1
N2 - Background: Complications can be classified using the most-severe Clavien-Dindo-Classification (CDC) per patient or the total complication burden per patient expressed in the Comprehensive Complication Index (CCI). This study determined the additional value of CCI to CDC in examining the impact of complications after gastric cancer surgery. Methods: The CCI and CDC were determined in the multicenter randomized LOGICA-trial comparing laparoscopic versus open D2-gastrectomy for cancer (cT1-4aN0-3M0). Differences in median CCI between laparoscopic and open gastrectomy were compared for overall postoperative complications and cardiovascular, gastrointestinal, infectious, pulmonary, and other complications. CCI and CDC were correlated to hospitalization, ICU-stay and reoperations using Spearman's rho-test and compared with standard Fisher's z-transformation. Results: Between 2015 and 2018, 211 patients underwent laparoscopic (n = 106) or open (n = 105) D2-gastrectomy, and 157 (74%) received neoadjuvant chemotherapy. Median CCI was comparable between laparoscopic versus open gastrectomy regarding overall complications (CCI 0 [IQR 0–23.5] versus 0 [IQR 0–22.6]; p = 0.755) and subgroups of complications (p > 0.05). Both CCI and CDC showed moderate positive correlations for hospitalization (rs = 0.646 versus rs = 0.628; p = 0.001, difference clinically irrelevant), and reoperations (rs = 0.590 versus rs = 0.599; p = 0.070), and weak correlations for ICU-stay (rs = 0.446 versus rs = 0.440; p = 0.189). Conclusions: The CCI is a composite scoring system based on the CDC and reflects a subjective interpretation of complication burden from the perspectives of both physicians and patients, following abdominal surgery other than gastrectomy. Implementing CCI showed no clinically relevant benefit and caused additional workload compared to CDC for assessing complication burden. Therefore, using the CCI alongside the CDC after gastric cancer surgery is not recommended.
AB - Background: Complications can be classified using the most-severe Clavien-Dindo-Classification (CDC) per patient or the total complication burden per patient expressed in the Comprehensive Complication Index (CCI). This study determined the additional value of CCI to CDC in examining the impact of complications after gastric cancer surgery. Methods: The CCI and CDC were determined in the multicenter randomized LOGICA-trial comparing laparoscopic versus open D2-gastrectomy for cancer (cT1-4aN0-3M0). Differences in median CCI between laparoscopic and open gastrectomy were compared for overall postoperative complications and cardiovascular, gastrointestinal, infectious, pulmonary, and other complications. CCI and CDC were correlated to hospitalization, ICU-stay and reoperations using Spearman's rho-test and compared with standard Fisher's z-transformation. Results: Between 2015 and 2018, 211 patients underwent laparoscopic (n = 106) or open (n = 105) D2-gastrectomy, and 157 (74%) received neoadjuvant chemotherapy. Median CCI was comparable between laparoscopic versus open gastrectomy regarding overall complications (CCI 0 [IQR 0–23.5] versus 0 [IQR 0–22.6]; p = 0.755) and subgroups of complications (p > 0.05). Both CCI and CDC showed moderate positive correlations for hospitalization (rs = 0.646 versus rs = 0.628; p = 0.001, difference clinically irrelevant), and reoperations (rs = 0.590 versus rs = 0.599; p = 0.070), and weak correlations for ICU-stay (rs = 0.446 versus rs = 0.440; p = 0.189). Conclusions: The CCI is a composite scoring system based on the CDC and reflects a subjective interpretation of complication burden from the perspectives of both physicians and patients, following abdominal surgery other than gastrectomy. Implementing CCI showed no clinically relevant benefit and caused additional workload compared to CDC for assessing complication burden. Therefore, using the CCI alongside the CDC after gastric cancer surgery is not recommended.
KW - Clavien-Dindo-classification
KW - Comprehensive complication index
KW - Gastric cancer
KW - Postoperative complications
KW - Postoperative recovery
UR - http://www.scopus.com/inward/record.url?scp=85175266860&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ejso.2023.107095
DO - https://doi.org/10.1016/j.ejso.2023.107095
M3 - Article
C2 - 37913608
SN - 0748-7983
VL - 49
JO - European Journal of Surgical Oncology
JF - European Journal of Surgical Oncology
IS - 12
M1 - 107095
ER -