title: Laparoscopic-assisted versus open total mesorectal excision with anal sphincter preservation for mid and low rectal cancer: a prospective, randomized trial.
abstract: BACKGROUND
  This single-center, prospective, randomized trial was designed to compare the short-term clinical outcome between laparoscopic-assisted versus open total mesorectal excision (TME) with anal sphincter preservation (ASP) in patients with mid and low rectal cancer. Long-term morbidity and survival data also were recorded and compared between the two groups.
  
  
  METHODS
  Between August 2001 and August 2007, 80 patients with mid and low rectal cancer were randomized to receive either laparoscopic-assisted (40 patients) or open (40 patients) TME with ASP. The median follow-up time for all patients was 75.7 (range 16.9-115.7) months for the laparoscopic-assisted group and 76.1 (range 4.7-126.6) months for the open group. The primary endpoint of the study was short-term clinical outcome. Secondary endpoints included long-term morbidity rate and survival. Data were analyzed by intention-to-treat principle.
  
  
  RESULTS
  The demographic data of the two groups were comparable. Postoperative recovery was better after laparoscopic surgery, with less analgesic requirement (P < 0.001), earlier mobilization (P = 0.001), lower short-term morbidity rate (P = 0.043), and a trend towards shorter hospital stay (P = 0.071). The cumulative long-term morbidity rate also was lower in the laparoscopic-assisted group (P = 0.019). The oncologic clearance in terms of macroscopic quality of the TME specimen, circumferential resection margin involvement, and number of lymph nodes removed was similar between both groups. After curative resection, the probabilities of survival at 5 years of the laparoscopic-assisted and open groups were 85.9 and 91.3 %, respectively (P = 0.912). The respective probabilities of being disease-free were 83.3 and 74.5 % (P = 0.114).
  
  
  CONCLUSIONS
  Laparoscopic-assisted TME with ASP improves postoperative recovery, reduces short-term and long-term morbidity rates, and seemingly does not jeopardize survival compared with open surgery for mid and low rectal cancer ( http://ClinicalTrials.gov Identifier: NCT00485316).
authors.affiliation: Division of Colorectal Surgery, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, simonng@surgery.cuhk.edu.hk.
authors.forename: Simon S M
authors.initials: SS
authors.lastname: Ng
authors.forename: Janet F Y
authors.initials: JF
authors.lastname: Lee
authors.forename: Raymond Y C
authors.initials: RY
authors.lastname: Yiu
authors.forename: Jimmy C M
authors.initials: JC
authors.lastname: Li
authors.forename: Sophie S F
authors.initials: SS
authors.lastname: Hon
authors.forename: Tony W C
authors.initials: TW
authors.lastname: Mak
authors.forename: Dennis K Y
authors.initials: DK
authors.lastname: Ngo
authors.forename: Wing Wa
authors.initials: WW
authors.lastname: Leung
authors.forename: Ka Lau
authors.initials: KL
authors.lastname: Leung
mesh_terms: D001003:Anal Canal; D059248:Chemoradiotherapy; D061887:Conversion to Open Surgery; D013505:Digestive System Surgical Procedures / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D059351:Organ Sparing Treatments / Q000379:methods*; D011182:Postoperative Care; D011300:Preoperative Care; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery*; D015996:Survival Rate; D016896:Treatment Outcome