The results of a pair of comparably designed studies spanning the United States, Canada, Australia, and New Zealand are advising caution concerning the use of laparoscopic surgery in cases involving rectal cancer.
Advances in robotics, however, may change that.
The two studies, published in the Journal of the American Medical Association, compared minimally invasive resection surgery with open resection in cases involving a total of 961 patients and surgeons from 59 separate institutions.1-2
The results, according to the North American study’s authors, showed that “laparoscopic resection failed to meet the criterion for noninferiority for pathologic outcomes compared with open resection and was thus potentially inferior.”1
The Australasian study’s authors similarly concluded that a comparison of the two procedures did not establish noninferiority of the minimally invasive technique.2
“Although the overall quality of surgery was high, these findings do not provide sufficient evidence for the routine use of laparoscopic surgery,” the authors wrote.
Both studies randomly assigned patients with stage 2 or 3 rectal cancer to one or the other of the resection procedures. Both then compared the surgical outcomes based on a composite of the completeness of the total mesorectal excision, a clear circumferential radial margin (>1mm) and a distal margin without tumor.
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A total of 462 of the 486 initial enrollees were evaluable for analysis in the North American study, which involved surgeons from 35 institutions including Baylor University Medical Center, Cleveland Clinic, Mayo Clinic, Memorial Sloan Kettering Cancer Center, and Saint Paul’s Hospital in Vancouver, Canada, among others.1
Of the evaluable patients, 240 underwent laparoscopic surgery and 222 underwent open resection. Successful resection, the study found, occurred in 81.7% of the laparoscopic cases and 86.9% of the open resection cases (difference, -5.3%; 1-sided 95% CI: -10.8% to ∞; P for noninferiority = 0.41).