Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes

Abstract

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

Local control of sphincter‐preserving procedures and abdominoperineal resection for locally advanced low rectal cancer: Propensity score matched analysis

“…Our data have some features such as simultaneous LLN dissection or lower rate of radiotherapy, but we surmise that our results would be generalizable to other countries because similar tendencies could be observed even after stratification by these factors (Figure 3). Regarding radial margin involvement rate, an established risk factor of LR,22, 23, 24, 25 the respective results (4% and 6%) were not inferior to the CRM involvement rates from recent RCTs (3%‐22%) although the radial margins as to criterion of 1 mm or 2 mm were not evaluated in the present study 26, 27, 28, 29. However, it should be noted that most hospitals participating in the present study were leading institutes in cancer care in Japan, such as university hospitals and medical centers.…”

Is laparoscopic rectal surgery really not non-inferior?

“…The conversion rate was only 11.3% which suggested the quality of surgical experience was high. The authors concluded that their findings did not support the use laparoscopic rectal resection [10] .…”

“…The landmark multicentre RCTs include the early UK-based MRC CLASICC (Conventional vs. Laparoscopic-Assisted Surgery in Colorectal Cancer) trial [27] , the North American COLOR (Colon Cancer Laparoscopic or Open Resection) II trial [18] , the South Korean based COREAN (Comparison of Open Versus Laparoscopic Surgery for mid or low Rectal Cancer After Neoadjuvant Chemoradiotherapy) trial [20] , the Australian based ALaCaRT (Australian Laparoscopic Cancer of the Rectum Trial) trial [17] and the US based ACOSOG Z6051 [10] .…”

“…The removal of the rectum and its mesorectum allows for potentially curative resection, pathological staging, prognosis and aids in further treatment decisions [9] . The quality of this resection is associated with improved outcomes in terms of survival and locoregional recurrence, thus the push for standardised good quality surgery [10,11] .…”

“…Several studies have shown laparoscopic rectal surgery has failed to reach noninferiority when compared to open resection in terms of short term pathological outcomes [10,17] . However, early reports from some of the major trials are suggesting that laparoscopic rectal surgery and open resection are equivalent regarding long-term disease-free survival, overall survival and local recurrence [18][19][20] .…”