title: Short-term outcomes of laparoscopic intersphincteric resection from a phase II trial to evaluate laparoscopic surgery for stage 0/I rectal cancer: Japan Society of Laparoscopic Colorectal Surgery Lap RC.
abstract: BACKGROUND
  Laparoscopic intersphincteric resection (Lap ISR) is not yet an established technique and its safety and feasibility are unclear. Our aim was to clarify the safety and feasibility of Lap ISR for clinical stage 0/I rectal cancer (Lap RC) in a prospective multicenter study of laparoscopic surgery in Japan.
  
  
  METHODS
  To examine the technical and oncological feasibility of laparoscopic surgery for rectal cancer, we conducted a confirmatory phase II trial to evaluate laparoscopic surgery for preoperative clinical stage 0/I rectal cancer. Eligibility criteria included histologically proven carcinoma, size ≤ 8 cm, age 20-75 years, no bowel obstruction, and no prior chemotherapy or radiotherapy. Between February 2008 and September 2010, 495 patients with rectal cancer underwent laparoscopic surgery at 43 institutions. Patients' background characteristics and operative and postoperative outcomes were recorded prospectively.
  
  
  RESULTS
  Seventy-seven patients (15.6 %) underwent Lap ISR. A diverting stoma was created in 69 patients (89.6 %). Conversion to open surgery occurred in 4 patients (5.2 %): 2 patients were converted because of uncontrollable bleeding, and the other 2 patients because of the need for pelvic side wall lymphadenectomy. There was no mortality. Median operative time was 345 min (range = 198-565), median amount of blood loss was 100 ml (range = 0-1760), and three patients (3.9 %) were transfused intraoperatively. The median number of dissected lymph nodes was 14 (range = 3-33), and all (proximal, distal, and vertical) pathological cut margins were negative. Postoperative complications of grade 2 or more were detected in 17 patients (22.1 %), including anastomotic leakage in 5 (6.4 %), bowel obstruction in 5 (6.5 %), and surgical site infection in 2 (2.6 %). Abdominal drainage and diverting stoma were necessary in two patients (2.6 %) due to anastomotic leakage. Median length of postoperative hospital stay was 13 days (range = 7-167).
  
  
  CONCLUSIONS
  Lap ISR was feasible and safe for clinical stage 0/I rectal cancer with favorable short-term outcome.
authors.affiliation: Department of Surgery, Gastroenterological Centre, Yokohama City University, 4-57 Urafunecho, Minami-ku, Yokohama, 232-0024, Japan. u0970047@urahp.yokohama-cu.ac.jp
authors.forename: Shoichi
authors.initials: S
authors.lastname: Fujii
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Masaaki
authors.initials: M
authors.lastname: Ito
authors.forename: Shigeki
authors.initials: S
authors.lastname: Yamaguchi
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Sakamoto
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Kinugasa
authors.forename: Yukihito
authors.initials: Y
authors.lastname: Kokuba
authors.forename: Junji
authors.initials: J
authors.lastname: Okuda
authors.forename: Kenichi
authors.initials: K
authors.lastname: Yoshimura
authors.forename: Masahiko
authors.initials: M
authors.lastname: Watanabe
mesh_terms: D001003:Anal Canal; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000473:pathology / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome