title: Laparoscopy versus open distal gastrectomy by expert surgeons for early gastric cancer in Japanese patients: short-term clinical outcomes of a randomized clinical trial.
abstract: BACKGROUND
  Short-term outcomes of laparoscopy-assisted distal gastrectomy (LADG) and open DG (ODG) have been investigated in previous clinical trials, but operative techniques and concomitant treatments have evolved, and up-to-date evidence produced by expert surgeons is required to provide an accurate image of the relative efficacies of the treatments. The purpose of this study was to compare laparoscopic versus ODG with respect to specific primary and secondary short-term outcomes.
  
  
  METHODS
  From October 2005 to February 2008, a total of 64 patients with early gastric cancer were randomly assigned to the LADG or the ODG group. One patient was excluded due to concurrent illness unrelated to the intervention, so the data from 63 patients were analyzed. The primary short-term outcome was the 4-day postoperative use of analgesics. Secondary short-term outcomes were postoperative residual pain, complications, days hospitalized, blood data, days with fever, and days to first flatus.
  
  
  RESULTS
  There was a significant difference in favor of LADG for postoperative use of analgesics (P = 0.022). Unexpectedly, there was no significant difference in degree of pain in the immediate postoperative period, putatively due to the optimal use of analgesics. Of the secondary outcomes, residual pain at postoperative day 7 (P = 0.003) and days to first flatus (P = 0.001) were significantly better with LADG. Postoperative complications, number of days hospitalized, and number of days with fever were also better with LADG, but the differences were not significant. Blood data representing inflammation (WBC and CRP) showed marked differences, especially on postoperative day 7 (P = 0.0016 and P = 0.0061, respectively).
  
  
  CONCLUSIONS
  LADG performed by expert surgeons results in less postoperative pain accompanied by decreased surgical invasiveness and is associated with fewer postoperative inconveniences. No preliminary suggestions of changes in long-term curability were observed. LADG for early gastric cancer is a feasible and safe procedure with short-term clinical results superior to those of ODG.
authors.affiliation: Department of Surgery, Kitasato University School of Medicine, 2-1-1 Asamizodai, Sagamihara, Kanagawa 228-8520, Japan. sakura@med.kitasato-u.ac.jp
authors.forename: Shinichi
authors.initials: S
authors.lastname: Sakuramoto
authors.forename: Keishi
authors.initials: K
authors.lastname: Yamashita
authors.forename: Shiro
authors.initials: S
authors.lastname: Kikuchi
authors.forename: Nobue
authors.initials: N
authors.lastname: Futawatari
authors.forename: Natsuya
authors.initials: N
authors.lastname: Katada
authors.forename: Masahiko
authors.initials: M
authors.lastname: Watanabe
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Okutomi
authors.forename: Guoqin
authors.initials: G
authors.lastname: Wang
authors.forename: Leon
authors.initials: L
authors.lastname: Bax
mesh_terms: D000285:Administration, Rectal; D000368:Aged; D016058:Analgesia, Patient-Controlled; D000700:Analgesics / Q000627:therapeutic use; D002277:Carcinoma / Q000473:pathology / Q000601:surgery*; D015897:Comorbidity; D019091:Critical Pathways; D005260:Female; D005334:Fever / Q000097:blood / Q000209:etiology; D005743:Gastrectomy / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage / Q000627:therapeutic use; D007273:Injections, Intramuscular; D007564:Japan; D010535:Laparoscopy / Q000379:methods* / Q000706:statistics & numerical data; D007813:Laparotomy / Q000379:methods / Q000706:statistics & numerical data; D007902:Length of Stay / Q000706:statistics & numerical data; D008197:Lymph Node Excision; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D010149:Postoperative Pain / Q000188:drug therapy / Q000451:nursing; D010423:Pentazocine / Q000627:therapeutic use; D011028:Pneumoperitoneum, Artificial; D020127:Recovery of Function; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D010423:Pentazocine; D007213:Indomethacin