Predictive Value of KLASS-02-QC Assessment Score on KLASS-02 Surgical Outcomes: Validation of Surgeon Quality Control and Standardization for D2 Lymphadenectomy.

Objective: The aim of this study was to audit the 22 items and assessed each item's predictive value on surgical outcomes.
Background: The KLASS-02 trial revealed that the oncologic outcomes of laparoscopic distal gastrectomy are not inferior to open distal gastrectomy in patients with advanced gastric cancer. The surgeons participating in this trial were chosen based on the assessment scores from the KLASS-02-QC trial, which used 22 items for standardization of D2 lymphadenectomy and quality control.
Methods: We reviewed proficiency scores (PSs) for 22 items for 20 surgeons who participated in KLASS-02. The surgeons were divided into 2 groups according to PS, and the perioperative outcomes of 924 patients enrolled in KLASS-02 were compared between groups. Each item's predictive value for perioperative outcome was then assessed using multivariable regression models.
Results: Of the total 924 patients, 529 were operated on by high-score surgeons (high PS) and 395 were operated on by low-score surgeons (low-PS). High-PS group had less intraoperative blood loss, longer operation times, and fewer complications, major complications, reoperations, and shorter first flatus and hospital stay than low-PS group ( P =0.006, P <0.001, P <0.001, P <0.001, P =0.042, P =0.013, and P <0.001, respectively). Some items used in KLASS-02-QC predicted perioperative outcomes, such as intraoperative blood loss, major complications, reoperation, and hospital stay.
Conclusions: Although this study only analyzed data associated with qualified surgeons, the 22 items effectively assessed the surgeons based on PS. A high score was associated with longer operation times, but better perioperative outcomes.
Competing Interests: W.J.H. reported receiving grants from Medtronic and GC pharma, stocks from Hutom, and personal fees from SK Hynix (Wuxi) outside the submitted work. S.-U.H. reported receiving grants from the National R&D Program for Cancer Control and Ethicon Endo-Surgery, a Johnson & Johnson Company, during the study period. S.-H.K. reported receiving grants from Medtronic and Stryker outside the submitted work. D.J.P. reported receiving grants from Daewoong Pharmaceuticals, JW Pharmaceuticals, and Medtronic outside the submitted work. J.W.K. reported receiving grants from the DN Company Co. Ltd research fund outside the submitted work. The remaining authors report no conflicts of interest.
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