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. 2015 Apr 27;33(16):1797–1808. doi: 10.1200/JCO.2014.60.1054

Table 2.

Multicentric, Prospective Randomized Trials Comparing Laparoscopic and Open TME for Rectal Adenocarcinoma

Variable Trial Name
CLASICC*
COLOR II
COREAN
Laparascopic v Open P Laparascopic v Open P Laparascopic v Open P
Neoadjuvant RT and/or CRT Stratified by RT 58/59 100/100
Operative time, minutes 135/180 188/240 < .001 197/224.9 .001
Blood loss, mL N.R. 400/200 < .001 217/200 .006
Conversion rate, % 34 17 1
APE, % 27/25 N.S. 23/29 .120 14/11 .708
Complete TME, % 67/79 92/88 .250 88/92 .55
Positive CRM, % 14/16§ .8 10/10 .850 4/3 .77
No. of lymph nodes 13.5/12 14/13 .085 18/17 .08
Time to first bowel movement, days 6/5 3/2 < .001 5.12/4.02 < .001
Hospital stay, days 13/11 9/8 .036 9/8 .056
28-Day mortality, % 5/4 .57 2/1 .41 0/0
Morbidity, % 37/40 37/40 .42 23.5/21.1 .603
3-Year oncologic outcomes
    Local recurrence, % 10.1/9.7 .96 N.A. 4.9/2.6
    Distant metastasis, % 16.4/18.6 .68 N.A. 20/17
    DFS, % N.A. .87 N.A. 72.5/79.2
    OS, % 67/73 .12 N.A. 90.4/91.7

Abbreviations: APE, abdominoperineal excision; CLASICC, Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer; COLOR II, Laparoscopic Versus Open Rectal Cancer Removal; COREAN, Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer; CRM, circumferential resection margin; CRT, chemoradiotherapy; DFS, disease-free survival; N.A., not available; N.R., not reported; N.S., not significant; OS, overall survival; RT, radiotherapy; TME, total mesorectal excision.

*

The CLASICC trial accrued a total of 794 patients (413 colon cancer; 381 rectal cancer).

Patients randomly assigned to laparoscopic or open surgery at a 1:2 ratio.

Not discriminated colon and rectum.

§

Positive CRM in patients having sphincter-saving procedure was 12% for laparoscopic group and 6% for the open group.