title: Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial.
abstract: BACKGROUND
  Laparoscopic-assisted surgery for colorectal cancer has been widely adopted without data from large-scale randomised trials to support its use. We compared short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer to predict long-term outcomes.
  
  
  METHODS
  Between July, 1996, and July, 2002, we undertook a multicentre, randomised clinical trial in 794 patients with colorectal cancer from 27 UK centres. Patients were allocated to receive laparoscopic-assisted (n=526) or open surgery (n=268). Primary short-term endpoints were positivity rates of circumferential and longitudinal resection margins, proportion of Dukes' C2 tumours, and in-hospital mortality. Analysis was by intention to treat. This trial has been assigned the International Standard Randomised Controlled Trial Number ISRCTN74883561.
  
  
  RESULTS
  Six patients (two [open], four [laparoscopic]) had no surgery, and 23 had missing surgical data (nine, 14). 253 and 484 patients actually received open and laparoscopic-assisted treatment, respectively. 143 (29%) patients underwent conversion from laparoscopic to open surgery. Proportion of Dukes' C2 tumours did not differ between treatments (18 [7%] patients, open vs 34 [6%], laparoscopic; difference -0.3%, 95% CI -3.9 to 3.4%, p=0.89), and neither did in-hospital mortality (13 [5%] vs 21 [4%]; -0.9%, -3.9 to 2.2%, p=0.57). Apart from patients undergoing laparoscopic anterior resection for rectal cancer, rates of positive resection margins were similar between treatment groups. Patients with converted treatment had raised complication rates.
  
  
  CONCLUSIONS
  Laparoscopic-assisted surgery for cancer of the colon is as effective as open surgery in the short term and is likely to produce similar long-term outcomes. However, impaired short-term outcomes after laparoscopic-assisted anterior resection for cancer of the rectum do not yet justify its routine use.
authors.affiliation: Academic Unit of Surgery, St James's University Hospital, Leeds, UK. p.j.guillou@leeds.ac.uk
authors.forename: Pierre J
authors.initials: PJ
authors.lastname: Guillou
authors.forename: Philip
authors.initials: P
authors.lastname: Quirke
authors.forename: Helen
authors.initials: H
authors.lastname: Thorpe
authors.forename: Joanne
authors.initials: J
authors.lastname: Walker
authors.forename: David G
authors.initials: DG
authors.lastname: Jayne
authors.forename: Adrian M H
authors.initials: AM
authors.lastname: Smith
authors.forename: Richard M
authors.initials: RM
authors.lastname: Heath
authors.forename: Julia M
authors.initials: JM
authors.lastname: Brown
mesh_terms: D000368:Aged; D015179:Colorectal Neoplasms / Q000601:surgery*; D005260:Female; D006801:Humans; D007431:Intraoperative Complications; D010535:Laparoscopy / Q000009:adverse effects; D008297:Male; D011183:Postoperative Complications; D011788:Quality of Life