title: Laparoscopic surgery for stage 0/I rectal carcinoma: short-term outcomes of a single-arm phase II trial.
abstract: OBJECTIVE
  To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, we conducted a single-arm phase II trial to evaluate laparoscopic surgery for stage 0/I rectal carcinoma, and short-term surgical outcomes were evaluated.
  
  
  METHODS
  Accredited surgeons from 43 institutions in Japan participated in the study. Eligibility criteria included histologically proven rectal carcinoma; clinical stage 0/I; tumor size 8 cm or smaller; patient age 20 to 75 years; no bowel obstruction; and written informed consent. Patients were registered preoperatively. The planned sample size was 490. Surgical outcomes were evaluated.
  
  
  RESULTS
  A total of 495 patients were registered between February 2008 and August 2010. Five patients were ineligible after registration. Conversion to open surgery was needed for 8 (1.6%) patients. Sphincter-preserving procedures were performed in 477 (97%) patients. Median operative time was 270 minutes, and median blood loss was 28 mL. Postoperative median intervals until liquid and solid intake were 1 and 3 days, respectively, and the median postoperative hospital stay was 12 days. The positive resection margin rate was 0.4% (2/490), and 68.6% (336/490) of the patients were graded stage 0/I. There were no perioperative mortalities. Twenty-four intraoperative and 160 postoperative complications occurred, and the morbidity rate was 23.9% (117/490). The anastomotic leakage rate in patients who underwent anterior resection was 8.3% (33/400), and that in patients who underwent intersphincteric resection was 9.1% (7/77). Nineteen (3.9%) patients underwent reoperation.
  
  
  CONCLUSIONS
  Technically, laparoscopic surgery can be used for safe and radical resection of clinical stage 0/I rectal carcinoma. (ClinicalTrials.gov No. NCT00635466.).
authors: Division of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan. miyamamo@jcom.home.ne.jp
authors: Seiichiro
authors: S
authors: Yamamoto
authors: Masaaki
authors: M
authors: Ito
authors: Junji
authors: J
authors: Okuda
authors: Shoichi
authors: S
authors: Fujii
authors: Shigeki
authors: S
authors: Yamaguchi
authors: Kenichi
authors: K
authors: Yoshimura
authors: Kenichi
authors: K
authors: Sugihara
authors: Masahiko
authors: M
authors: Watanabe
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D061887:Conversion to Open Surgery / Q000706:statistics & numerical data; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007431:Intraoperative Complications / Q000453:epidemiology; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011183:Postoperative Complications / Q000453:epidemiology; D012004:Rectal Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D012007:Rectum / Q000473:pathology / Q000601:surgery*; D015996:Survival Rate; D016896:Treatment Outcome