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Page 4 of 8 O’Donohue et al. Mini-invasive Surg 2018;2:24 I http://dx.doi.org/10.20517/2574-1225.2018.34

laparoscopic group and 6% for the open group. As compared to the 2015 ALaCaRT trial which had a 6.7%
[27]
positive CRM rate in the laparoscopic group .

COLOR II trial was a noninferiority trial that recruited 1044 patients from 30 centres across 8 countries
between 2004 and 2010, with adenocarcinoma of the rectum, within 15 cm of the anal verge. The primary
outcome measure was to compare the locoregional recurrence after 3 years. Secondary outcome measures
was 3-year disease free and overall survival. Included in the analysis was a comparison of the pathological
data of the resected rectums. On pathological analysis the authors did not find any significant difference in
[18]
TME quality, CRM or distal resection margin (DRM) .

The COREAN trial recruited 340 (170 patients in each group) patients with mid to low rectal cancer from
3 tertiary hospitals in South Korea between 2006 and 2009. It differs from the other trials in that all their
patients received neoadjuvant chemoradiotherapy, whereas not all patients received neoadjuvant treatment
in ALaCaRT or ACOSOG Z6051. Short term outcome measures such as CRM, TME quality, DRM and
number of harvested lymph nodes were collected. Other measures such as post-operative quality of life,
morbidity and return of bowel function were also investigated. Secondary outcomes included longer term
outcomes (disease free and overall survival) at 3 years. Pathological assessment of the resected specimen
in this study showed no statistical difference between the groups. The authors in this study supported the
use laparoscopic rectal surgery after neoadjuvant chemoradiotherapy as it had an improved short-term
benefit regarding post-operative outcomes and its pathological assessment was equivalent between the two
[20]
groups .

ALaCaRT was a multicentre, randomised, noninferiority trial which aimed to investigate the safety and
outcomes of laparoscopic rectal surgery as compared to open surgery. It recruited 475 patients (237 open
resection group and 238 laparoscopic resection group) from 24 institutions from across Australia and New
Zealand between 2010 and 2014 with T1-T3 rectal cancers within 15 cm of the anal verge. The primary aim
of the study was to compare pathological outcome of the resected specimen. Secondary outcome measures
compared were disease free survival, local pelvic recurrence at 2 years and overall survival at 5 years. The
oncological quality of the specimen was a composite measure of completeness of TME, CRM and DRM.
A successful resection needed to fulfil all the requirements of the composite outcome. The major distinc-
tion of this trial compared to the other landmark trials was the incorporation of the hybrid technique into
the open group. The results failed to show that laparoscopic rectal surgery is non-inferior to open rectal
surgery with only 82% of laparoscopic resected specimens being considered successful in contrast to 89% of
the open group. However, the quality of the surgery was high, with 87% of laparoscopic TME’s being com-
plete, 93% of CRM negative and a clear DRM in 99%. The conversion from laparoscopic to open was only 9%.
The authors concluded that there wasn’t sufficient evidence for the routine incorporation of laparoscopic
[17]
rectal surgery. The longer-term outcome measures are still awaited .

ACOSOG Z6051 was a similar study to ALaCaRT as it also evaluated the short term pathological outcomes
using the composite outcome measures defined previously. It was a multicentre, randomised control trial
that recruited 462 patients with clinical stage II or III rectal cancer (laparoscopic resection n = 240, open
resection n = 222) from 35 institutions across the United States and Canada between October 2008 to Sep-
tember 2013. The only difference is that the ACOSOG Z6051 defined an acceptable TME as either complete
or nearly complete (TME Grades 2 and 3) whereas the ALaCaRT trial only considered a complete TME
(TME Grade 3) as successful. As with the ALaCaRT trial this multicentre trial failed to prove that laparo-
scopic rectal cancer was non-inferior to open rectal surgery. The results revealed 81.7% of laparoscopically
resected specimens as compared to 86.9% of the open group were successful resections with respect to the
composite pathological outcome measure. 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 laparo-
[10]
scopic rectal resection .