To determine whether laparoscopic surgery is noninferior to open surgery for rectal cancer in terms of quality of surgical resection outcomes.
Randomized clinical trials (RCTs) have evaluated the oncologic safety of laparoscopic versus open surgery for rectal cancer with conflicting results. Prior meta-analyses comparing these operative approaches in terms of quality of surgical resection aimed to demonstrate if one approach was superior. However, this method is not appropriate and potentially misleading when noninferiority RCTs are included.
MEDLINE, EMBASE, and Cochrane were searched to identify RCTs comparing these operative approaches. Risk differences (RDs) were pooled using random-effects meta-analyses. One-sided Z tests were used to determine noninferiority. Noninferiority margins (ΔNI) for circumferential resection margin (CRM), plane of mesorectal excision (PME), distal resection margin (DRM), and a composite outcome (“successful resection”) were based on the consensus of 58 worldwide experts.
Fourteen RCTs were included. Laparoscopic resection was noninferior compared with open resection for the rate of positive CRM [RD 0.79%, 90% confidence interval (CI) −0.46 to 2.04, ΔNI = 2.33%, P NI = 0.026], incomplete PME (RD 1.16%, 90% CI −0.27 to 2.59, ΔNI = 2.85%, P NI = 0.025), and positive DRM (RD 0.15%, 90% CI −0.58 to 0.87, ΔNI = 1.28%, P NI = 0.005). For the rate of “successful resection” (RD 6.16%, 90% CI 2.30–10.02), the comparison was inconclusive when using the ΔNI generated by experts (ΔNI = 2.71%, P NI = 0.07), although no consensus was achieved for this ΔNI.
Laparoscopy was noninferior to open surgery for rectal cancer in terms of individual quality of surgical resection outcomes. These findings are concordant with RCTs demonstrating noninferiority for long-term oncologic outcomes between the 2 approaches.
*Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada
†Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada
‡Department of Surgery, St. Michael's Hospital, Toronto, ON, Canada
§Division of General Surgery, Department of Surgery, University of Toronto, Toronto, ON, Canada
¶Department of Surgery, Maimonides Medical Center, Brooklyn, NY
||Departments of Paediatrics, Mount Sinai Hospital and University of Toronto, Toronto, ON, Canada
**Department of Surgery, Mount Sinai Hospital, Toronto, ON, Canada.
Reprints: Dr Nancy N. Baxter, MD, PhD, Division of General Surgery, St. Michael's Hospital, 040-16 Cardinal Carter Wing, 30 Bond Street, Toronto, ON M5B 1W8, Canada. E-mail: BaxterN@smh.ca.
Funding: This study was funded by a Canadian Institutes of Health Research (CIHR) Knowledge Synthesis Grant (Funding Reference No. 362493) and the CIHR Foundation Grant (Funding Reference No. 148470). The funding sources had no role in the design or conduct of the study; collection, management, analysis or interpretation of the data; or preparation, review or approval of the manuscript.
There are no conflicts of interest to disclose.
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