Kentaro Nakajima1, Masafumi Inomata2, Tomonori Akagi1, Tsuyoshi Etoh1, Kenichi Sugihara3, Masahiko Watanabe4, Seiichiro Yamamoto5, Hiroshi Katayama6, Yoshihiro Moriya5, Seigo Kitano7. 1. Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita. 2. Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita inomata@oita-u.ac.jp. 3. Department of Surgical Oncology, Tokyo Medical and Dental University, Tokyo. 4. Department of Surgery, Kitasato University Hospital, Kanagawa. 5. Division of Colorectal Surgery, National Cancer Center Hospital, Tokyo. 6. JCOG Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo. 7. Oita University Faculty of Medicine, Oita, Japan.
Abstract
OBJECTIVE: The quality of surgery with D3 resection in randomized controlled clinical trial [Japan Clinical Oncology Group study (JCOG0404)] was assessed by evaluation of the photo documentation of both open and laparoscopic surgeries. METHODS: A multi-institutional randomized-controlled trial (JCOG0404) was conducted to evaluate open and laparoscopic D3 resection (complete mesocolic excision + ligation and dissection at the root of the main vessels) for Stage II/III colon cancer (UMIN-CTR number C000000105). A total of 1057 (open, 528; laparoscopic, 529) eligible patients were enrolled. For quality control, it was ensured that the surgeries were performed by accredited surgeons, and a central committee reviewed each surgery on the basis of the submitted photographs of the resected field, specimen and skin incision. RESULTS: For right-sided tumors, the rate of D3 resection was 98.5% (131/133) in the open arm and 100% (136/136) in the laparoscopic arm, and for left-sided tumors, they were 97.9% (322/329) and 98.2% (320/326), respectively. Sufficient length of the resected longitudinal margin was ensured in all cases. The skin incisions made in all the cases were <8 cm as defined in the protocol in laparoscopic arm. CONCLUSIONS: Completion of high quality surgery with D3 resection was confirmed in JCOG0404 by central peer review of photographs of the surgical procedures in addition to operator regulations. This study suggests that the central review of the photo documentation is one of the important tools to assure a quality control of surgical technique in the Phase III randomized-controlled study.
RCT Entities:
OBJECTIVE: The quality of surgery with D3 resection in randomized controlled clinical trial [Japan Clinical Oncology Group study (JCOG0404)] was assessed by evaluation of the photo documentation of both open and laparoscopic surgeries. METHODS: A multi-institutional randomized-controlled trial (JCOG0404) was conducted to evaluate open and laparoscopic D3 resection (complete mesocolic excision + ligation and dissection at the root of the main vessels) for Stage II/III colon cancer (UMIN-CTR number C000000105). A total of 1057 (open, 528; laparoscopic, 529) eligible patients were enrolled. For quality control, it was ensured that the surgeries were performed by accredited surgeons, and a central committee reviewed each surgery on the basis of the submitted photographs of the resected field, specimen and skin incision. RESULTS: For right-sided tumors, the rate of D3 resection was 98.5% (131/133) in the open arm and 100% (136/136) in the laparoscopic arm, and for left-sided tumors, they were 97.9% (322/329) and 98.2% (320/326), respectively. Sufficient length of the resected longitudinal margin was ensured in all cases. The skin incisions made in all the cases were <8 cm as defined in the protocol in laparoscopic arm. CONCLUSIONS: Completion of high quality surgery with D3 resection was confirmed in JCOG0404 by central peer review of photographs of the surgical procedures in addition to operator regulations. This study suggests that the central review of the photo documentation is one of the important tools to assure a quality control of surgical technique in the Phase III randomized-controlled study.
Authors: Giuseppe S Sica; Danilo Vinci; Leandro Siragusa; Bruno Sensi; Andrea M Guida; Vittoria Bellato; Álvaro García-Granero; Gianluca Pellino Journal: Surg Endosc Date: 2022-09-12 Impact factor: 3.453