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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_1705_Библиотеки_им_академика_М_И_Перельмана.pdf
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- •Foreword
- •Contents
- •References
- •Discussion
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- •Discussion
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- •The Statistical Analysis
- •References
- •Discussion
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190
stantial risk of lateral lymph node metastasis. So, this idea that
you could remove the mesorectum with intact mesorectal fascia
without treating the lateral lymph nodes is not sufcient. You need
to do something else. And this feeds my skepticism on some of
the implications of the Mercury trial on the reduction in radio-
therapy use. This trial puts into perspective the risk of lateral
lymph node metastases and the importance of radiotherapy in the
adequate patient if you do not do lateral lymph node dissection.
That is why I found that trial interesting. There is follow-up data
indicating that the two approaches are comparable. So, from that
perspective, perhaps, it is less relevant to a Western surgeon who
would not do prophylactic lateral lymph node dissection anyway.
AM
There is a secondary paper to the main trial because this was the
paper which looked at morbidity and mortality. The main trial was
looking at, as you said, total mesorectal excision (TME) vs. TME
with lateral pelvic lymphatic dissection. They excluded those
patients who did not have clinically positive lateral nodes, and they
dened clinically positive lymph nodes as greater than a centimeter
in diameter, which is different than a more contemporary denition.
LS
Sure.
AM
So, in that original paper, their primary endpoint was recurrence-
free survival. When they compared those who had lateral nodes
versus those who did not, the local recurrence was higher, 13% vs.
7% for those who did not have lateral pelvic node dissection. But
to me, the main thing about this trial is that this was all in the
27 Lateral Lymph Node Metastatic Involvement inRectal Cancer

191
absence of chemotherapy and radiotherapy. And that is the biggest
reason why it is not necessarily applicable to modern-day practice
other than the fact that we must be cognizant, as you mentioned,
of what you can say are invisible lateral positive nodes that are
probably treated by chemoradiotherapy in Western practice. And
in those who do not undergo chemoradiotherapy, we should still
consider pursuing lateral lymph node dissection whether patients
refuse chemoradiotherapy for those that qualify, but potentially
even in those tumors that do not. But this trial only included stage
II and stage III.
LS
This is the same trial that you mentioned, and yes, it was the rst
publication related to pathology results and morbidity and then
the oncologic results, which actually were the objective of the
trial came up later, and they were published in 2020.
MD
I agree with you, Amit. I just feel that this study is not really
relevant to our practice in the United States because, especially
in the era of TNT and watch-and-wait, I mean, everyone is get-
ting neoadjuvant chemotherapy and radiation therapy with
locally advanced rectal tumors, which otherwise would have
treated a lot of these lateral lymph nodes. I think the other issue
with this study is that not all these patients were proactively
examined with an MRI.If you look at the methods, it says that
they were staged with a Computed Tomography (CT) scan or
MRI. And I imagine that there were many patients, especially
now with better MRI technology that were missed on preopera-
tive imaging if they were just getting a CT scan instead of an
MRI which would have increased the detection rate of clinically
positive lymph nodes adding to the 7% of occult lateral metasta-
ses in the study.
Discussion

192
AM
There is a subsequent study out of Japan looking at lateral nodes
for patients who had stage II and III tumors and a clinically posi-
tive lateral node, unlike this trial which included patients who do
not have clinically positive lymph nodes. They looked at lateral
node dissection, with or without neoadjuvant chemotherapy. All
patients underwent lateral node dissection, and those who did not
have neoadjuvant chemotherapy had worse overall survival and
worse recurrence rates, including a worse local recurrence rate.
They subsequently looked at the question for which we have some
data, the MD Anderson data, on the resolution of clinically
positive notes post therapy, but I think that data is very limited.
We do not have any other robust data to tell us what to do with a
patient who has a clinically positive node which becomes clini-
cally negative post treatment. Do you still do a lateral node dissec-
tion or do you not? And then what do you dene as clinically
positive vs. negative? That is debated as well.
LS
I think this is an evolving eld that is sort of germane to this study.
This entity called the Lateral Node Study Consortium has found
that also patients who have just four-millimeter lymph nodes fol-
lowing neoadjuvant treatment were at increased risk of recurrence
if the lymph nodes were in the internal iliac compartment. This is a
pretty specialistic kind of treatment discussion. I do not see fre-
quently patients who need lateral lymph node dissection. And I
know there’s a debate about who should do it; certainly, I agree that
the practices which accrued patients into this trial are different from
ours, but I do feel that we should pay more attention than in the past
to lateral lymph node metastases because now surgery for rectal
cancer is largely optimized, at least for the accepted management of
the mesorectum to reduce the risk of local recurrence. I think we do
not have all the answers to these various questions of what to do
with the clinical negative nodes, what constitutes clinically positive
27 Lateral Lymph Node Metastatic Involvement inRectal Cancer

193
nodes, and if there is a difference between internal iliac versus obtu-
rator lymph nodes. I do not do a lateral lymph node dissection regu-
larly, although I have treated locally recurrent rectal cancer with
enlarged lymph nodes, but if this is a rare although necessary tech-
nique to use, then the question is also who should be doing this, if
there should be only one person in a certain group that should be
doing it. These are all questions that I think as time goes by will
come to the fore.
AM
I think there is convincing data on a large number of patients indi-
cating that those who have a positive lateral node should undergo
a lateral pelvic dissection at the time of TME.I think the part that
is unknown is whether this is still required if that node becomes
clinically negative. The biggest trial that I know of, I think it was
published in JCO in 2018, was a retrospective review of 1200 odd
patients. It included those who had T3–T4 tumors and underwent
TME.If they had a pretreatment MRI that showed a positive lat-
eral node, dened as bigger or equal to 7 mm, which they saw in
I think just under 20% of patients, those patients who did not
undergo a lateral node dissection post treatment at the time of
surgery did worse. But there was no review as to whether that
node became clinically negative post treatment. Did all patients
still need that or not? I think that is what is not clear. The current
limited data we have would probably say, or at least I think the
one that we see quoted the most from MD Anderson says they
may not necessarily need that if that node becomes clinically neg-
ative. And at least that is my practice. I do not feel that you need
to necessarily go after that clinically positive node which becomes
clinically negative post treatment.
Discussion

195
© The Author(s), under exclusive license to Springer Nature
Switzerland AG 2025
D. Colibaseanu et al., Essential Articles in Colorectal Surgery,
https://doi.org/10.1007/978-3-031-77745-5_28
28
Robotic Surgery forRectal
Cancer
Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J,
Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M,
Bianchi PP, Edlin R, Hulme C, Brown J.Effect of robotic-assisted
vs conventional laparoscopic surgery on risk of conversion to
open laparotomy among patients undergoing resection for rectal
cancer: the ROLARR Randomized Clinical Trial. JAMA.
2017;318(16):1569–80.
Abstract
Importance: Robotic rectal cancer surgery is gaining popularity,
but limited data are available regarding safety and efcacy.
Objective: To compare robotic-assisted versus conventional
laparoscopic surgery for risk of conversion to open laparotomy
among patients undergoing resection for rectal cancer.
Design, Setting, and Participants: Randomized clinical trial
comparing robotic-assisted versus conventional laparoscopic sur-
gery among 471 patients with rectal adenocarcinoma suitable for
curative resection conducted at 29 sites across 10 countries,
including 40 surgeons. Recruitment of patients was from January
7, 2011, to September 30, 2014, follow-up was conducted at 30
days and 6 months, and nal follow-up was on June 16, 2015.
Interventions: Patients were randomized to robotic-assisted
(n = 237) or conventional (n=234) laparoscopic rectal cancer
resection, performed by either high (upper rectum) or low (total

196
rectum) anterior resection or abdominoperineal resection (rectum
and perineum).
Main Outcomes and Measures: The primary outcome was
conversion to open laparotomy. Secondary endpoints included
intraoperative and postoperative complications, circumferential
resection margin positivity (CRM+) and other pathological out-
comes, quality of life (36-Item Short Form Survey and 20-item
Multidimensional Fatigue Inventory), bladder and sexual dys-
function (International Prostate Symptom Score, International
Index of Erectile Function, and Female Sexual Function Index),
and oncological outcomes.
Results: Among 471 randomized patients (mean [SD] age,
64.9 [11.0] years; 320 [67.9%] men), 466 (98.9%) completed the
study. The overall rate of conversion to open laparotomy was
10.1%. The overall CRM+ rate was 5.7%. Of the other, 8 reported
prespecied secondary endpoints, including intraoperative com-
plications, postoperative complications, plane of surgery, 30-day
mortality, bladder dysfunction, and sexual dysfunction, none
showed a statistically signicant difference between groups.
Conclusions and Relevance: Among patients with rectal ade-
nocarcinoma suitable for curative resection, robotic-assisted lapa-
roscopic surgery, as compared with conventional laparoscopic
surgery, did not signicantly reduce the risk of conversion to open
laparotomy. These ndings suggest that robotic-assisted laparo-
scopic surgery, when performed by surgeons with varying experi-
ence with robotic surgery, does not confer an advantage in rectal
cancer resection.
MD
The Robotic vs. Laparoscopic Resection for Rectal Cancer
(ROLARR) trial published in 2017 was a randomized controlled
trial comparing laparoscopy to robotic surgery for low rectal cancer.
This remains the largest RCT comparing these two surgical tech-
niques in rectal cancer. The primary endpoint was the rate of conver-
sion to open surgery. The study was powered based on an anticipated
25% conversion rate following conventional laparoscopic surgery,
28 Robotic Surgery forRectal Cancer

197
given the 34% conversion rate of the previously mentioned
CLASICC trial, the best available evidence at the time of the original
ROLARR design, and accounting for advances in surgical technol-
ogy. Four hundred and seventy-one patients were randomized to
either robotic or laparoscopic surgery. The overall positive CRM
rate was 5.7%. There was no difference in the conversion rate
between the two groups [12.2 % laparoscopic vs. 8.1% robotic
(unadjusted difference in proportions 4.1% [95% CI, −1.4% to
9.6%]) and no difference with respect to odds of conversion (adjusted
OR=0.61 [95% CI, 0.31–1.21] P=0.16)]. There were no differ-
ences in any secondary outcomes including positive CRM rate,
intraoperative complications, postoperative complications, 30-day
mortality, bladder dysfunction, and sexual dysfunction. A subgroup
analysis limited to male patients indicated a statistically signicant
difference in conversion rates favoring robotic surgery (robotic 8.7%
vs. laparoscopic 16%, CI: 0.1–14.6). The authors concluded that
robotic surgery does not confer any signicant benet over laparos-
copy in rectal cancer. However, ROLARR ended up being under-
powered based on its actual conversion rates. In addition, the
participating surgeons might have been experts in conventional lapa-
roscopic surgery but still in their learning curve in robotic surgery,
thus confounding the study results.
The ROLARR trial was published during my chief year of gen-
eral surgery residency and had a signicant impact on my training
as I entered fellowship. Due to the results of this study and I am
sure many other factors unbeknownst to me, my program did not
emphasize or invest in a robotics program. As a result, I had min-
imal robotic training in fellowship. I had a signicant amount of
robotic training during my general surgery residency, and so
despite having limited exposure in fellowship, I was able to use
robotics in my practice early on. Though this study did not show
a benet of robotic surgery compared to laparoscopy, it impor-
tantly did not show any difference in short-term oncologic or peri-
operative outcomes, and so despite the increased cost associated
with robotics, I implemented robotic surgery into my practice.
Due to limited availability, I used robotics primarily for the pelvis
and rectal cancer. A signicant factor in being able to do an appro-
priate laparoscopic TME, especially for a low pelvic tumor, is
MD

198
having a good rst assistant. This is not always possible depend-
ing on the type of institution one is practicing in, which was the
situation I was in when I rst started practice. In addition to
improved visualization and dexterity, the robotic platform allows
the surgeon to perform an appropriate TME with much less assis-
tance, thus enabling the surgeon to have the ability to perform an
MIS procedure that may have not been possible with laparoscopy
and an inexperienced assistant. So, although the ROLARR study
did not show signicant differences in outcomes between laparos-
copy and robotics, it is still highly benecial in these situations.
Where it did show benet was for those very challenging cases in
male patients with a high BMI. ROLARR remains the largest ran-
domized controlled trial evaluating robotics vs. laparoscopy in
rectal cancer; however, since its publications, there have been sev-
eral studies conrming equivalent oncologic outcomes between
laparoscopy and robotics and furthermore showing benets of
robotic surgery including decreased conversion to open and
improved functional outcomes [1–3]. With this data, I think that
the robotic platform will only continue to show benets as sur-
geons become more experienced with this technology and as tech-
nology in robotics continues to evolve.
References
1. Muaddi H, Had ME, Choi WJ, Lillie E, de Mestral C,
Nathens A, etal. Clinical outcomes of robotic surgery com-
pared to conventional surgical approaches (laparoscopic or
open): a systematic overview of reviews. Ann Surg.
2021;273(3):467–73.
2. Lam J, Tam MS, Retting RL, McLemore EC.Robotic versus
laparoscopic surgery for rectal cancer: a comprehensive review
of oncological outcomes. Perm J. 2021;25:21.050.
3. Flynn J, Larach JT, Kong JCH, Waters PS, McCormick JJ,
Warrier SK, et al. Patient-related functional outcomes after
robotic-assisted rectal surgery compared with a laparoscopic
approach: a systematic review and meta-analysis. Dis Colon
Rectum. 2022;65(10):1191–204.
28 Robotic Surgery forRectal Cancer

199
Discussion
MD
This study was published toward the end of my residency and had
a signicant impact on my training. Despite the initial enthusiasm
surrounding robotics, particularly in reducing conversion rates, the
study did not yield the expected results. Consequently, during my
fellowship training, exposure to robotic procedures was limited,
and the emphasis continued with laparoscopy. While there were
likely other contributing factors unbeknownst to me, the perceived
cost-benet analysis appeared to be a signicant consideration.
Since its publication, this study has been criticized for its
underpowered analysis and differences in expertise between
robotic and laparoscopic approaches. I think with advancements
in robotic technology and increased surgeon experience, it is plau-
sible that the results of such a study conducted today could differ
favoring robotics. Moreover, subsequent research from single-
institution studies has highlighted the potential benets of robot-
ics, including decreased conversion to open surgery and improved
functional outcomes.
In my clinical practice, the benets of robotic surgery are par-
ticularly pronounced in the pelvis, cases involving obese patients,
and for performing intracorporeal anastomosis and suturing. The
robotic platform affords me the ability to undertake minimally
invasive procedures, even in the most complex scenarios, which
in my hands would be nearly impossible with laparoscopy, espe-
cially in the absence of an experienced assistant. While this study
may not have shown a signicant benet of robotics, the contin-
ued adoption of robotics, despite its costs, suggests that its bene-
ts, particularly for specic patient demographics like males and
the obese, are still recognized and valued.
LS
I do feel that you can see better in the pelvis in robotic surgery. In
my early and still recent robotic experience, I had a patient in
Discussion

200
whom I encountered pelvic bleeding while dissecting the rectum.
I decided to convert to open, and I could not believe how small the
pelvis was when I converted. It was a very different experience
from laparoscopic surgery, I can tell you that. Another important
aspect of robotic surgery is fatigue, especially for older surgeons.
I think that robotic surgery is easier on your body than laparo-
scopic surgery. You can end up having to position your body in a
sort of twisted position to retract a certain structure or to look at
the monitor. In robotic surgery, this is not the case.
MD
With regard to cost, as more robotic platforms are introduced into
the market, I anticipate that this will gradually mitigate some of
the initial costs associated with implementing robotic systems. I
agree that cost remains a relative factor, contingent upon the insti-
tution and geographic location. In addition, Intuitive now offers
alternatives to upfront purchases, allowing for contractual
arrangements, almost like a rental agreement. This undoubtedly
inuences the overall cost considerations, particularly depending
on one’s workplace or training environment.
DC
From my perspective, just looking at the trial, I think that this
was probably viewed with similar enthusiasm as Z 6051 (laparo-
scopic vs. open proctectomy trial). I think that in many ways, the
horse was out of the barn, so to speak, at least for those surgeons
who had adopted robotic surgery with enthusiasm. The patients
also started asking about robotic surgery. Regardless whether
robotic surgery can be shown to be superior or at least not infe-
rior to laparoscopic technique, it was going to be adopted. And I
would say that younger surgeons are more likely to learn the
robot rather than laparoscopic, which is backwards from when I
was trained. I think it is a great tool in the pelvis. It has denitely
shown that over time, it has technical advantages, as well as the
28 Robotic Surgery forRectal Cancer
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