title: A prospective feasibility and safety study of laparoscopy-assisted distal gastrectomy for clinical stage I gastric cancer initiated by surgeons with much experience of open gastrectomy and laparoscopic surgery.
abstract: BACKGROUND
  The aim of this prospective study was to evaluate the feasibility and safety of laparoscopy-assisted distal gastrectomy (LADG) initiated by surgeons with much experience of open gastrectomy and laparoscopic surgery.
  
  
  METHODS
  Three surgeons who each had experience with more than 300 cases of open gastrectomy, more than 100 cases of laparoscopic cholecystectomy, more than 5 cases of laparoscopic colectomy, and more than 5 cases of laparoscopic partial gastrectomy were nominated as LADG operators. All three operators received training for LADG with study materials including videotapes, a box simulator, and an animal laboratory, with lectures and assistance from LADG instructors who each had experience of more than 50 LADG operations. Then the nominated LADG operators performed LADG with the instructors, in which their skills were evaluated and certified. Thereafter, they performed LADG without assistance from the instructors. The target of this study was clinical stage I gastric cancer that was resectable by distal gastrectomy. D1 + alpha, D1 + beta, or D2 dissection was performed laparoscopically. Basically reconstruction was done extracorporeally with a Billroth-I gastroduodenostomy. An extramural review board checked the surgical quality of the operations performed by the three surgeons. The primary endpoint was morbidity and mortality.
  
  
  RESULTS
  A total of 193 patients were enrolled in this study between August 2004 and July 2009. The median blood loss was 35 ml and the median operation time was 250 min. Conversion to open surgery was seen in 6 patients; 4 due to bleeding and 2 due to advanced disease. Overall morbidity was 1.6 %, including grade 2 anastomotic leakage in 0.5 % and grade 2 pancreatic fistula in 0.5 %. No mortality was observed. The number of cases required until the LADG operators acted as LADG surgeons without an instructor was 3 for each of the three surgeons. When comparing the data between that in the training period (n = 9) and the operators' data (n = 174), the median operation time was significantly longer in the training period (355 min) than in the latter period (247.5 min) (p = 0.015). Median blood loss was also greater in the training period (150 ml) than the latter period (32.5 ml), but the difference did not reach statistical significance (p = 0.084). During the training period, no patient developed any complications of ≥ grade 2.
  
  
  CONCLUSIONS
  These results suggested that LADG could be initiated and performed feasibly and safely if surgeons with much experience of open gastrectomy and laparoscopic surgery received adequate training for LADG.
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2 Nakao, Asahi-ku, Yokohama, 241-0815, Japan. yoshikawat@kcch.jp
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Cho
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Rino
authors.forename: Yuji
authors.initials: Y
authors.lastname: Yamamoto
authors.forename: Masayuki
authors.initials: M
authors.lastname: Kimura
authors.forename: Tetsu
authors.initials: T
authors.lastname: Fukunaga
authors.forename: Shinichi
authors.initials: S
authors.lastname: Hasegawa
authors.forename: Takanobu
authors.initials: T
authors.lastname: Yamada
authors.forename: Toru
authors.initials: T
authors.lastname: Aoyama
authors.forename: Akira
authors.initials: A
authors.lastname: Tsuburaya
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016063:Blood Loss, Surgical / Q000517:prevention & control; D004502:Education, Medical, Continuing / Q000379:methods*; D005260:Female; D005743:Gastrectomy / Q000193:education / Q000379:methods* / Q000401:mortality; D005763:Gastroenterostomy / Q000379:methods; D006801:Humans; D007431:Intraoperative Complications; D010535:Laparoscopy / Q000193:education / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome; D055815:Young Adult