Elsevier

The Lancet

Volume 365, Issue 9472, 14–20 May 2005, Pages 1718-1726
The Lancet

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

https://doi.org/10.1016/S0140-6736(05)66545-2Get rights and content

Summary

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.

Introduction

The past two decades have witnessed substantial improvements in the survival from colorectal cancer resulting from earlier diagnosis, improved efficiency and delivery of chemotherapy and radiotherapy, and advances in surgical techniques such as total mesorectal excision.1 However, the mainstay of cure remains adequate surgical excision of the primary tumour. Since its initial use more than a decade ago2, 3, 4 curative colorectal resection may now be achieved with laparoscopic assistance, bringing advantages to patients such as more rapid recovery, fewer complications, and shorter duration of hospital stay than for those with standard treatment. Of the many non-randomised studies of laparoscopic resections,5, 6, 7, 8 most have concluded that the procedure is safe, despite previous concerns about atypical patterns of tumour recurrence, such as in the port sites.9, 10 However, randomised trials of colon cancer11, 12, 13, 14 have provided data for survival and disease-free intervals that do not show any reduced survival in laparoscopic-assisted treatment.

Results of large-scale randomised trials should be available and should address the concerns that laparoscopic surgery compromises surgical principles.15, 16, 17, 18 The UK Medical Research Council (MRC) trial of conventional versus laparoscopic-assisted surgery in colorectal cancer (CLASICC) was designed as a pragmatic trial to incorporate the standard clinical endpoints of survival and disease-free intervals, and to provide a detailed pathological analysis of all resected samples.19 We used these short-term endpoints as surrogates to predict long-term clinical outcomes20 and also assess the quality of surgery in not only cancer of the colon but also cancer of the rectum.

Section snippets

Patients

Between July, 1996, and July, 2002, we undertook a randomised, controlled, open, parallel-group trial comparing laparoscopic-assisted surgery with conventional open surgery in patients with cancer of the colon or rectum from 27 UK centres. These patients were suitable for right hemicolectomy, left hemicolectomy, sigmoid colectomy, anterior resection, or abdominoperineal resection. Exclusion criteria were adenocarcinoma of the transverse colon, contraindications to pneumoperitoneum (chronic

Results

During the trial, 794 patients (268 randomly allocated to open surgery, 526 to laparoscopic surgery) from 32 surgeons were recruited (figure 1). 657 (83%) patients were recruited by surgeons who randomised more than 20 patients. The two groups were balanced with respect to baseline characteristics and pathological staging (table 1). Most procedures were undertaken with curative intent (ie, R0 or R1 classifications). As expected, length of incision was shorter for the laparoscopic group than for

Discussion

In our study, no differences were recorded between open surgery and laparoscopic-assisted surgery for colorectal cancer with respect to tumour and nodal status, short-term endpoints, and quality of life. Apart from patients undergoing laparoscopic anterior resection for rectal cancer, the positivity rates of surgical resection margins were also similar between the two treatment groups. In patients with cancer of the rectum, total mesorectal excision was undertaken more frequently in the group

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