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Esen et al. Mini-invasive Surg 2018;2:29 I http://dx.doi.org/10.20517/2574-1225.2018.32 Page 3 of 8

In the randomized COLOR II trial including 1103 patients with rectal cancer, although the duration of lap-
aroscopic surgery was longer than that of open surgery (240 min vs. 188 min), blood loss was significantly
[27]
less (200 mL vs. 400 mL), and the length of hospital stay was shorter (8 days vs. 9 days) . There were no
significant differences in the rate of CRM positivity, number of HLNs, or distal surgical margins between
the two groups.

In the CLASSIC trial that included 27 UK centers and 381 patients with rectal cancer were randomized
[6]
to open (n = 128) and laparoscopic (n = 253) surgery groups . The rate of conversion to open surgery was
34%, whereas perioperative morbidity did not differ between the two groups. There was a nonsignificant
increase in CRM positivity in the laparoscopic anterior resection group compared with the open surgery
group (12% vs. 6%), suggesting a slight increase in the risk of recurrence. The 3- and 5-year follow-up stud-
ies of all rectal cancer patients revealed that there were no differences in local or distant recurrence rates
between the laparoscopic and open surgical groups [28,29] .

In the COREAN trial including 340 patients with locally advanced rectal cancer (T3N0-2) from three cen-
ters were randomized to open (n = 170) and laparoscopic surgery (n = 170) groups, and all patients received
[30]
neoadjuvant chemoradiotherapy . The rate of conversion to open surgery was 1.2%, and no differences
between the two groups were observed in terms of postoperative morbidity, mortality, CRM positivity, or
TME quality.

The ACOSOG Z6051 trial recruited stage IIA or III rectal cancer patients with a tumor ≤ 12 cm from the
anal verge after neoadjuvant therapy. The trial was powered to detect the noninferiority of laparoscopic
[31]
surgery . Conversion to open surgery occurred in 11.3% of the patients. The authors demonstrated that
there were no differences in radial or distal margin positivity or complete or near-total TME between the
laparoscopy and open surgery groups.

The design of ALaCaRT trial was similar to that of ACOSOG Z6051, recruiting T1-3 and N0-2 rectal cancer
[10]
patients with a tumor ≤ 15 cm from the anal verge to assess the noninferiority of laparoscopic surgery .
Although the length of laparoscopic surgery was longer, the blood loss was less in this group. There is no
difference in the completeness of TME between the laparoscopic and open surgery groups (82% vs. 89%),
CRM positivity was observed in 7% and 3% of the laparoscopy and open surgery group patients, respec-
tively (P = 0.06), and the rate of conversion to open surgery was 9%. In this study, the laparoscopy group,
especially those with large T3 tumors, failed to meet the noninferiority criteria. The controversy of this
study with COREAN and COLOR II trials raised the question of whether there were any indications for
laparoscopy in lower rectal cancers and locally advanced disease.

[32]
A prospective nonrandomized study by Lujan et al. including 4405 patients from 72 centers who were
divided into the laparoscopic (n = 1387) and open surgery (n = 3018) groups showed that the laparoscopy
group had less hospitalization time, blood loss, and postoperative morbidity compared with the open sur-
gery group. There was no significant difference in the number of HLNs between the two groups (laparoscopy
vs. open, 14.5 vs. 14.7). The CRM and the distal margin involvement were significantly better in the laparo-
scopic group (P < 0.05), but the completeness of TME was significantly better in the open surgery group (P
< 0.05).

[33]
In a two-center prospective study by Ströhlein et al. laparoscopic surgery was associated with faster
recovery and shorter hospital stays than open surgery. There is a significant difference in the number of
HLNs between the laparoscopic and the open surgical groups (13.5 vs. 16.9; P = 0.001); however, no differ-
ences local recurrence or metachronous metastasis were observed between the two groups.

In summary, these trials demonstrated that there were no differences in local tumor clearance, number
of HLNs, or tumor recurrence rates between the two surgical approaches in patients with rectal cancer.