2012 EDUCATIONAL BOOK - American Society of Clinical Oncology

outcomes; local, wound-site, and distant recurrences; 5-year
overall and disease-free survival; and urinary and sexual
function did not differ significantly between the two groups.
Summary of Current Evidence
The United Kingdom MRC CLASICC trial finding of
increased CRM positivity within the laparoscopic anterior
resection group raised questions about the oncologic competence
of this procedure. The question of adequacy is answered
by the 5-year follow-up results. The COREAN trial
concludes that laparoscopic surgery for rectal cancer, performed
by skillful laparoscopic surgeons in high-volume
centers, is feasible and has promising short-term results.
As we await the long-term results of the aforementioned
ongoing trials (the COREAN, COLOR II, JCOG 0404, and
ACOSOG-Z6051 trials), one topic must be considered before
applying the results to general practice: how to prepare and
qualify operators so that patients receive the maximum
benefits of MIS.
Learning Curve for Laparoscopic Surgery for Rectal
Cancer: Is There a Magic Number?
As previously noted, rectal resection is more demanding
than colectomy because of the anatomy of the pelvis, the
desirability of preserving autonomic nerve function, and the
sequelae of neoadjuvant treatment. In conventional open
surgery, the retractor is a key factor in achieving adequate
exposure, especially in male patients with a bulky mesorectal
tumor and narrow pelvis. Appropriate TME should be
performed by sharp (not blunt) dissection to achieve the best
oncologic outcome. All of these considerations make laparoscopic
rectal resection more challenging.
One study from Japan analyzed the learning curve for
laparoscopic low anterior resection. 21 Single surgeons performed
250 operations, with patients divided into five
groups. The learning curve analysis demonstrated that
operative time stabilized after 50 cases. The conversion rate
was significantly lower after 150 cases (p � 0.05), correlating
with male sex and advanced T stage. Other studies have
suggested that an adequate learning curve is passed at
somewhere between 20 and 60 cases. 6,7,22,23 In laparoscopic
TME, adequacy of exposure without use of the retractor is
necessary. Therefore, not only the experience of the surgeon
but the aptitude of the entire surgical team is important.
The mirror image from the camera and the alignment of the
first assistant’s working instruments in opposite positions
may disorient the assistant operator. One study concluded
that assisting in more than 30 to 40 cases is sufficient to
overcome mirror-image movements. 24
Existing published reports show no final agreement regarding
the optimal number of cases necessary to achieve
technical expertise. Extrapolated from the COST study,
ASCRS and the Society of Gastrointestinal and Endoscopic
Surgeons (SAGES) recommend that a practitioner complete
at least 20 laparoscopic resections of benign colon lesions
before being credentialed for colon cancer resection. 9 Undoubtedly,
completing a large number of operations correlates
with better outcomes. One good example is the
correlation between high-volume surgeons (all ranked
among the top one-third in operative experience in their
respective cancer centers) and impressive short-term results
216
TRAKARNSANGA AND WEISER
shown in the COREAN trial. 12 This begs the question: How
can operators pass the learning curve without putting patients
at risk? Simulation and animal and cadaveric training
courses are currently available worldwide; however, it is not
known if this kind of training sufficiently qualifies a surgeon
to perform resection in human patients. From our perspective,
the answer is still uncertain. Intraoperative supervision
by an experienced surgeon as well as appropriate case
selection should be major considerations in any training
program, even at an advanced level. This is essential to safe
clinical practice. 25
Is There Any Benefit to Hand-Assisted Laparoscopy?
It has been suggested that hand-assisted laparoscopic
colectomy has potential benefits, including a shorter learning
curve for the practitioner, less operative time, and lower
conversion rate compared to conventional laparoscopic surgery.
This may be especially true in complex procedures
such as total proctocolectomy. 26-28 Unfortunately, several
difficult issues are associated with hand-assisted laparoscopy.
Placing a hand into the abdominal cavity may have
iatrogenic effects including a traumatic affect on the immune
system, which may eliminate the long-term benefits of
MIS (such as fewer postoperative adhesions). Interleukin 6
(IL-6) and C-reactive protein (CRP) are sensitive markers of
the immune system’s acute inflammatory response, and
exaggeration of these may actually have a deleterious effect
on wound healing and increase the risk of postoperative
infection. 29,30 Several human studies have shown significant
lowering of IL-6 and CRP in laparoscopic compared with
open surgery (p � 0.05, p � 0.007, and p � 0.001). 29 In two
animal studies comparing hand-assisted laparoscopic surgery
(HALS) with laparoscopic surgery, slightly higher levels
of IL-6 and CRP were reported with HALS; however, the
levels of these cytokines were significantly lower than the
levels seen in open surgery (p � 0.04 and p � 0.05). 30,31 No
comparative human study has been reported.
Regarding long-term complications, one retrospective
study compared 266 hand-assisted operations with 270
laparoscopic operations for colorectal disease. After a 27month
median follow-up, the incidence of small bowel obstruction
was not significantly different between the handassisted
versus laparoscopic groups (4.1% vs. 7.4%; p �
0.10), nor was the rate of postoperative incisional hernia
(6% vs. 4.8%; p � 0.54). 32 Based on these results, we may
conclude that hand-assisted surgery does not appear to be
inferior to laparoscopic surgery, and retains the potential
benefits of MIS.
HALS for rectal cancer is challenging because, as noted
above, the pelvic space is restricted by its bony anatomic
structure. On the positive side, the hand may be used as an
effective retractor to achieve adequate exposure. Unfortunately,
in a deep and narrow pelvis, the hand may not be a
useful tool because of the limited anatomic space. A multicenter
prospective, randomized study comparing handassisted
with straight laparoscopic-assisted proctectomy for
rectal cancer is currently in the recruitment phase. 33 The
planned sample size is 128 cases; estimated accrual will end
by December 2012. The primary outcome is operative time.
The secondary outcomes include adequacy of resection margins;
in-hospital mortality and morbidity; and preoperative
as well as 3- and 6-month postoperative follow-ups of uri-