title: Quality control by photo documentation for evaluation of laparoscopic and open colectomy with D3 resection for stage II/III colorectal cancer: Japan Clinical Oncology Group Study JCOG 0404.
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.
authors.affiliation: Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Nakajima
authors.affiliation: Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita inomata@oita-u.ac.jp.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Inomata
authors.affiliation: Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Akagi
authors.affiliation: Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Etoh
authors.affiliation: Department of Surgical Oncology, Tokyo Medical and Dental University, Tokyo.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Sugihara
authors.affiliation: Department of Surgery, Kitasato University Hospital, Kanagawa.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Watanabe
authors.affiliation: Division of Colorectal Surgery, National Cancer Center Hospital, Tokyo.
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Yamamoto
authors.affiliation: JCOG Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Katayama
authors.affiliation: Division of Colorectal Surgery, National Cancer Center Hospital, Tokyo.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Moriya
authors.affiliation: Oita University Faculty of Medicine, Oita, Japan.
authors.forename: Seigo
authors.initials: S
authors.lastname: Kitano
mesh_terms: D000328:Adult; D000368:Aged; D003082:Colectomy / Q000379:methods* / Q000592:standards*; D015179:Colorectal Neoplasms / Q000473:pathology* / Q000601:surgery*; D004210:Dissection / Q000592:standards; D005260:Female; D006801:Humans; D021621:Imaging, Three-Dimensional; D007564:Japan; D010535:Laparoscopy; D008297:Male; D008499:Medical Records / Q000592:standards*; D008875:Middle Aged; D009367:Neoplasm Staging; D010781:Photography; D011786:Quality Control
keywords: colorectal cancer; laparoscopy; photograph; quality control; surgery