IMPORTANCE Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete, particularly for patients with more advanced-stage disease. OBJECTIVE To determine whether laparoscopic resection is noninferior to open resection, as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen. DESIGN, SETTING, AND PARTICIPANTS A multicenter, balanced, noninferiority, randomized trial enrolled patients between October 2008 and September 2013. The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada. A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection. INTERVENTIONS Standard laparoscopic and open approaches were performed by the credentialed surgeons. MAIN OUTCOMES AND MEASURES The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm, distal margin without tumor, and completeness of total mesorectal excision. A 6%noninferiority margin was chosen according to clinical relevance estimation. RESULTS Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled. Successful resection occurred in 81.7%of laparoscopic resection cases (95%CI, 76.8%–86.6%) and 86.9%of open resection cases (95%CI, 82.5%–91.4%) and did not support noninferiority (difference, −5.3%; 1-sided 95%CI, −10.8%to ∞; P for noninferiority = .41). Patients underwent low anterior resection (76.7%) or abdominoperineal resection (23.3%). Conversion to open resection occurred in 11.3%of patients. Operative time was significantly longer for laparoscopic resection (mean, 266.2 vs 220.6 minutes; mean difference, 45.5 minutes; 95%CI, 27.7–63.4; P < .001). Length of stay (7.3 vs 7.0 days; mean difference, 0.3 days; 95%CI, −0.6 to 1.1), readmission within 30 days (3.3%vs 4.1%; difference, −0.7%; 95%CI, −4.2%to 2.7%), and severe complications (22.5%vs 22.1%; difference, 0.4%; 95%CI, −4.2%to 2.7%) did not differ significantly. Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete (77%) and nearly complete (16.5%) in 93.5%of the cases. Negative circumferential radial margin was observed in 90% of the overall group (87.9% laparoscopic resection and 92.3%open resection; P = .11). Distal margin result was negative in more than 98%of patients irrespective of type of surgery (P = .91). CONCLUSIONS AND RELEVANCE Among patients with stage II or III rectal cancer, the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes. Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00726622

Background-Cardiac stress testing in patients at low risk for acute coronary syndrome is associated with increased false-positive test results, unnecessary downstream procedures, and increased cost. We judged it unlikely that patient preferences were driving the decision to obtain stress testing. Methods and Results-The Chest Pain Choice trial was a prospective randomized evaluation involving 204 patients who were randomized to a decision aid or usual care and were followed for 30 days. The decision aid included a 100-person pictograph depicting the pretest probability of acute coronary syndrome and available management options (observation unit admission and stress testing or 24 -72 hours outpatient follow-up). The primary outcome was patient knowledge measured by an immediate postvisit survey. Additional outcomes included patient engagement in decision making and the proportion of patients who decided to undergo observation unit admission and cardiac stress testing. Compared with usual care patients (nϭ103), decision aid patients (nϭ101) had significantly greater knowledge (3.6 versus 3.0 questions correct; mean difference, 0.67; 95% CI, 0.34 -1.0), were more engaged in decision making as indicated by higher OPTION (observing patient involvement) scores (26.6 versus 7.0; mean difference, 19.6; 95% CI, 1.6 -21.6), and decided less frequently to be admitted to the observation unit for stress testing (58% versus 77%; absolute difference, 19%; 95% CI, 6%-31%). There were no major adverse cardiac events after discharge in either group. Conclusions-Use of a decision aid in patients with chest pain increased knowledge and engagement in decision making and decreased the rate of observation unit admission for stress testing.

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Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.