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Laparoscopic versus open surgery for rectal cancer: individual patient data meta-analysis of the ALaCaRT and Z6051 randomized trials

In brief

Laparoscopic rectal cancer surgery leads to about three percent more local recurrences at three years

In a pooled analysis of 935 patients, laparoscopic proctectomy had a 5.4% three-year locoregional recurrence rate versus 2.0% after open surgery, a difference of roughly three percent. Pathologically successful resections were also slightly less frequent with laparoscopy. While disease-free survival was similar, the higher local recurrence raises questions about long-term oncologic safety.

Journal
BJS open (Q1)
Published
3 July 2026
Study design
Systematic review / meta-analysis of RCTs
Evidence level
Level 1, High (CEBM 1a)
Authors
Kilian G M Brown, Andrew R L Stevenson, Michael J Solomon, James Murray, Kate Wilson, Val Gebski, et al.
PMID
42565372
DOI
10.1093/bjsopen/zrag119

Why clinicians should know about it

Abstract

BACKGROUND: The multicentre ALaCaRT and ACOSOG Z6051 randomized trials were unable to demonstrate non-inferiority of laparoscopic versus open surgery for rectal cancer with respect to a composite pathology metric indicating successful resection. Neither trial was individually powered to detect differences in long-term recurrence or survival. This planned meta-analysis determined long-term oncological outcomes of laparoscopic versus open proctectomy for rectal adenocarcinoma. METHODS: This prospective meta-analysis included individual patient data from patients with cT1-3 N0-2 M0 rectal adenocarcinoma enrolled in the ALaCaRT and ACOSOG Z6051 trials. Pathologically successful resection was defined as complete or near-complete total mesorectal excision, a clear circumferential resection margin (CRM; > 1 mm), and a clear distal resection margin (> 1 mm). The non-inferiority margin for disease-free survival (DFS) was an absolute difference of 5% at least 3 years after surgery. RESULTS: The combined data set included 935 patients (65.6% men, mean age 60.7 years, mean body mass index 26.7 kg/m2) randomized to open (457 patients) or laparoscopic (478 patients) proctectomy. Pathologically successful resection was lower in the laparoscopic than open group (85.1% versus 89.9%, respectively; pooled estimate 4.6% difference; 95% confidence interval (c.i.) -8.6% to -0.5%). The median follow-up was 60.2 (interquartile range 49.9-61.1) months. Three-year DFS was 75.2% (95% c.i. 71.1% to 79.2%) and 76.5% (95% c.i. 72.5% to 80.6%) for the laparoscopic and open groups, respectively (pooled estimate difference -1.5%; 95% c.i. -7.2% to 4.2%). Non-inferiority of laparoscopic surgery was not demonstrated because the lower one-sided 95% c.i. (-6.3% to 100%) crossed -5%. Three-year locoregional recurrence was higher in laparoscopic than open group (5.4% (95% c.i. 3.3% to 7.5%) versus 2.0% (95% c.i. 0.7% to 3.4%), respectively; pooled estimate 3.1% difference (95% c.i. 0.6% to 5.6%)). A clear CRM was the most significant and only pathological predictor of both DFS (P < 0.0001) and overall survival (P < 0.0001). CONCLUSION: Laparoscopic proctectomy led to a lower rate of pathologically successful resection and a higher rate of locoregional recurrence at 3 years. The possibility of subsequent poorer DFS or overall survival rate requires further evaluation, because this analysis was not specifically powered for these endpoints.

Abstract as published, via PubMed.

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For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.