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Observational Study
. 2021 Feb 1;273(2):315-324.
doi: 10.1097/SLA.0000000000003883.

Surgeon Quality Control and Standardization of D2 Lymphadenectomy for Gastric Cancer: A Prospective Multicenter Observational Study (KLASS-02-QC)

Sang-Uk Han  1 , Hoon Hur  1 , Hyuk-Joon Lee  2 , Gyu Seok Cho  3 , Min-Chan Kim  4 , Young Kyu Park  5 , Wook Kim  6 , Woo Jin Hyung  7 ; Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group
Affiliations
Observational Study

Surgeon Quality Control and Standardization of D2 Lymphadenectomy for Gastric Cancer: A Prospective Multicenter Observational Study (KLASS-02-QC)

Sang-Uk Han et al. Ann Surg. .

Abstract

Objective: To qualify surgeons to participate in a randomized trial comparing laparoscopic and open distal D2 gastrectomy for advanced gastric cancer.

Summary of background data: No studies have sought to qualify surgeons for a randomized trial comparing laparoscopic and open D2 gastrectomy for advanced gastric cancer.

Methods: We conducted a multicenter prospective observational study evaluating unedited videos of laparoscopic and open D2 gastrectomy performed by 27 surgeons. Surgeons performed 3 of each laparoscopic and open distal gastrectomies with D2 lymphadenectomy for gastric cancer. Five peers reviewed each unedited video using a video assessment form. Based on experts' review of videos, a separate review committee decided surgeons as "Qualified" or "Not-qualified."

Results: Twelve surgeons (44.4%) were qualified on initial evaluation whereas the other 15 surgeons were not. Another 9 surgeons were finally qualified after re-evaluation. The median score for Qualified was significantly higher than Not-qualified (P < 0.001).Significant differences between Qualified and Not-qualified were noted both in operation type and in all evaluation area of surgical skill, perigastric, and extra-perigastric lymphadenectomy, although the inter-rater variability of the assessment score was low (kappa = 0.285). However, Not-qualified surgeons' scores improved upon re-evaluation of resubmitted videos.When compared laparoscopy with open surgery, median scores were similar between the 2 groups (P = 0.680). However, open gastrectomy scores for surgical skills were significantly higher than for laparoscopic surgery (P = 0.016).

Conclusions: Our surgeon quality control study for gastrectomy represents a milestone in surgical standardization for surgical clinical trials. Our methods could also serve as a system for educating surgeons and assessing surgical proficiency.

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Conflict of interest statement

All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. Han reports grants from Ethicon Endo-Surgery during the conduct of the study. Dr Hyung reports receiving research grants from the Medtronic and is the chief executive officer of Hutom and holding its stocks. He provided consultancy services to Ethicon and Verb Surgical outside the submitted work. No other disclosures were reported. All investigators in this study have declared no potential conflicts of interest.

References

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