title: Effect of Laparoscopic-Assisted Resection vs Open Resection on Pathological Outcomes in Rectal Cancer: The ALaCaRT Randomized Clinical Trial.
abstract: OBJECTIVE
  Laparoscopic procedures are generally thought to have better outcomes than open procedures. Because of anatomical constraints, laparoscopic rectal resection may not be better because of limitations in performing an adequate cancer resection.
  
  
  OBJECTIVE
  To determine whether laparoscopic resection is noninferior to open rectal cancer resection for adequacy of cancer clearance.
  
  
  METHODS
  Randomized, noninferiority, phase 3 trial (Australasian Laparoscopic Cancer of the Rectum; ALaCaRT) conducted between March 2010 and November 2014. Twenty-six accredited surgeons from 24 sites in Australia and New Zealand randomized 475 patients with T1-T3 rectal adenocarcinoma less than 15 cm from the anal verge.
  
  
  METHODS
  Open laparotomy and rectal resection (n = 237) or laparoscopic rectal resection (n = 238).
  
  
  METHODS
  The primary end point was a composite of oncological factors indicating an adequate surgical resection, with a noninferiority boundary of Δ = -8%. Successful resection was defined as meeting all the following criteria: (1) complete total mesorectal excision, (2) a clear circumferential margin (≥1 mm), and (3) a clear distal resection margin (≥1 mm). Pathologists used standardized reporting and were blinded to the method of surgery.
  
  
  RESULTS
  A successful resection was achieved in 194 patients (82%) in the laparoscopic surgery group and 208 patients (89%) in the open surgery group (risk difference of -7.0% [95% CI, -12.4% to ∞]; P = .38 for noninferiority). The circumferential resection margin was clear in 222 patients (93%) in the laparoscopic surgery group and in 228 patients (97%) in the open surgery group (risk difference of -3.7% [95% CI, -7.6% to 0.1%]; P = .06), the distal margin was clear in 236 patients (99%) in the laparoscopic surgery group and in 234 patients (99%) in the open surgery group (risk difference of -0.4% [95% CI, -1.8% to 1.0%]; P = .67), and total mesorectal excision was complete in 206 patients (87%) in the laparoscopic surgery group and 216 patients (92%) in the open surgery group (risk difference of -5.4% [95% CI, -10.9% to 0.2%]; P = .06). The conversion rate from laparoscopic to open surgery was 9%.
  
  
  CONCLUSIONS
  Among patients with T1-T3 rectal tumors, noninferiority of laparoscopic surgery compared with open surgery for successful resection was not established. Although the overall quality of surgery was high, these findings do not provide sufficient evidence for the routine use of laparoscopic surgery. Longer follow-up of recurrence and survival is currently being acquired.
  
  
  BACKGROUND
  anzctr.org Identifier: ACTRN12609000663257.
authors.affiliation: Faculty of Medicine and Biomedical Sciences, University of Queensland, Brisbane, Australia2Royal Brisbane and Women's Hospital, Brisbane, Australia.
authors.forename: Andrew R L
authors.initials: AR
authors.lastname: Stevenson
authors.affiliation: Institute of Academic Surgery, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Solomon
authors.affiliation: Wesley Hospital, Brisbane, Australia.
authors.forename: John W
authors.initials: JW
authors.lastname: Lumley
authors.affiliation: Adelaide University Department of Surgery, Queen Elizabeth Hospital, Adelaide, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Hewett
authors.affiliation: Faculty of Medicine and Biomedical Sciences, University of Queensland, Brisbane, Australia2Royal Brisbane and Women's Hospital, Brisbane, Australia.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Clouston
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
authors.forename: Val J
authors.initials: VJ
authors.lastname: Gebski
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
authors.forename: Lucy
authors.initials: L
authors.lastname: Davies
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
authors.forename: Kate
authors.initials: K
authors.lastname: Wilson
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
authors.forename: Wendy
authors.initials: W
authors.lastname: Hague
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Simes
mesh_terms: D000236:Adenoma / Q000473:pathology / Q000601:surgery*; D000328:Adult; D013505:Digestive System Surgical Procedures / Q000379:methods*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D007813:Laparotomy; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D018365:Neoplasm, Residual; D011788:Quality of Life; D012004:Rectal Neoplasms / Q000473:pathology / Q000601:surgery*; D016037:Single-Blind Method; D016896:Treatment Outcome