UNASSIGNED: 3548 Background: Mesorectal excision (ME) is the international standard surgical procedure for lower @entity5 . However, lateral pelvic lymph node @entity3 is occasionally found in @entity1 with clinical stage II, III @entity5 , and therefore lateral lymph node dissection (LLND) is the standard procedure in Japan. We conducted a randomized controlled trial to confirm the non-inferiority of ME to ME with LLND in terms of efficacy. The primary analysis is planned for 2015, and this study is now in the follow-up stage. Morbidity and mortality were examined in this study. METHODS: Only surgeons specialized in both procedures from 33 Japanese institutions participated in the study. Eligibility criteria included histologically proven @entity5 ; clinical stage II/III; main lesion located in the rectum and the lower margin below the peritoneal reflection; no lateral pelvic lymph node swelling; PS of 0 or 1; @entity1 age 20-75 years. After surgeons had confirmed R0 resection by the ME procedure, @entity1 were randomized intraoperatively to ME only or ME with LLND by phone call to the Data Center. The primary endpoint was relapse-free survival, and the planned sample size was 700. Postoperative morbidity and hospital mortality were compared between the two groups. RESULTS: A total 701 @entity1 were randomized to ME (n = 350) or ME+LLND (n = 351) between June 2003 and August 2010. The incidence of lateral pelvic lymph node @entity3 was 7.4% in the ME+LLND group. The incidences of postoperative grade 3 or 4 complications in the ME group and the ME+LLND group were 16.1% and 21.7%, respectively (p = 0.07), and the corresponding incidences of @entity834 , including all grades, were 10.6% and 8.9%, respectively (p = 0.45). The reported hospital mortality rate was 0.14%: one @entity1 in the ME+LLND group died of @entity834 followed by @entity295 . CONCLUSIONS: The ME group tended to show lower postoperative morbidity than the ME+LLND group. The primary analysis planed for 2015 is pivotal to prove non-inferiority of ME to ME+LLND in terms of relapse-free survival.

Morbidity and mortality results from a prospective randomized trial comparing mesorectal excision with or without lateral lymph node dissection for clinical stage II and III lower XXXX : Japan Clinical Oncology Group study JCOG0212.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity295 :: ('MESH:D018805', 'Disease') :: ['sepsis'] @entity834 :: ('MESH:D057868', 'Disease') :: ['anastomotic leakage'] @entity5 :: ('MESH:D009369', 'Disease') :: ['rectal cancer'] @entity3 :: ('MESH:D009362', 'Disease') :: ['metastasis']
@entity5 :: (MESH:D009369,Disease) :: ['rectal cancer']
