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Clinical Trial
. 2005 May;365(9472):1718-26.
doi: 10.1016/S0140-6736(05)66545-2.

Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial

Pierre J Guillou  1 , Philip Quirke, Helen Thorpe, Joanne Walker, David G Jayne, Adrian M H Smith, Richard M Heath, Julia M Brown; MRC CLASICC trial group
Affiliations
Clinical Trial

Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial

Pierre J Guillou et al. Lancet. 2005 May.

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.

Findings: 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.

Interpretation: 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.

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Comment in

  • Laparoscopic-assisted resection of colorectal carcinoma.
    Curet MJ. Curet MJ. Lancet. 2005 May 14-20;365(9472):1666-8. doi: 10.1016/S0140-6736(05)66525-7. Lancet. 2005. PMID: 15894083 No abstract available.
  • MRC CLASICC trial.
    Slim K. Slim K. Lancet. 2005 Aug 27-Sep 2;366(9487):712-3; author reply 713-4. doi: 10.1016/S0140-6736(05)67169-3. Lancet. 2005. PMID: 16125579 No abstract available.
  • MRC CLASICC trial.
    Arulampalam TH, Austin RC, Motson RW. Arulampalam TH, et al. Lancet. 2005 Aug 27-Sep 2;366(9487):712; author reply 713-4. doi: 10.1016/S0140-6736(05)67168-1. Lancet. 2005. PMID: 16125581 No abstract available.
  • MRC CLASICC trial.
    Ng SS, Leung KL, Lee JF, Yiu RY, Li JC. Ng SS, et al. Lancet. 2005 Aug 27-Sep 2;366(9487):713; author reply 713-4. doi: 10.1016/S0140-6736(05)67170-X. Lancet. 2005. PMID: 16125582 No abstract available.

Associated data