Table 2.
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.