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116
you think of that patient population now just being devil’s advo-
cate about lack of ileostomy creation, those are patients who
didn’t have a sign of a clinical leak, had an early reversal, and then
developed a problem. Makes you question, I guess, the decision
of leaving a low anastomosis undiverted.
MD
So, what do you guys do in your practice? Based on some of the
data we have, I generally will divert those patients who have low
anastomoses less than seven centimeters from the anal verge and
underwent radiotherapy. Either or, not necessarily both. I like
applying both criteria. In what instance are you guys not divert-
ing? Radiated or low anastomosis?
AM
For me, it is not necessarily a number in terms of height, but
where the anastomosis is in relation to the anterior peritoneal
reection. If the anastomosis is below the peritoneal reection,
there is a far higher likelihood, I’m diverting them versus if it’s
above. And, I don’t know, just maybe it’s my own psychosis about
it. I just draw it as a line in the sand if it’s above, and if it’s only a
centimeter above, it’s still above to me. If it’s 5cm above, it’s
above. If it’s a centimeter below, it is below. For me, that’s prob-
ably the biggest determining factor. And then second, I would
guess, the delivery of radiation. But, for example, the transplant
patient population in which we operate on frequently, and this
may not necessarily be related to cancer and directly relevant to
this paper, is a population that’s on immunosuppressives. To me,
those patients don’t necessarily mandate a diversion just because
they’re on immunosuppression. Again, probably the biggest fac-
tor for me is relation to the anterior peritoneal reection.
17 The Role ofDiverting Loop Ileostomy asanAdjunct toLow…
117
DC
Yeah, I’d say for me—at least conceptually—it’s not necessarily a
specic anatomical set point. It is an evaluation of how much tension
there is on the anastomosis, and what are the consequences of a
leak? Can the patient even survive a potential leak, and is the anasto-
mosis so low that the leak jeopardizes any chance of being able to
establish intestinal continuity in the future? What is this patient’s
continence to begin with? I think that the exact distance of the anas-
tomosis from the anal verge is more of a “place holder” or equiva-
lency estimation for these considerations rather than an end onto
itself.
LS
I see your points, but I would say, having experienced both the
complications of a diverted ileostomy and its closure vs. low anas-
tomosis without proximal diversion, whenever there are any of
those factors that you mentioned, I tend to be liberal in diverting
because I feel the morbidity associated with a diverting ileostomy
and its closure is in general the lesser of the two evils. If some-
body is healthy, if their anastomosis is high, without tension, and
with a good blood supply, then I do not divert. But in all those
circumstances, malnutrition, or if I feel the patient is marginal due
to comorbidities, I divert. I have also diverted all patients on
immunosuppression for transplant. I recognize that perhaps we
should be more selective in the transplant patients and depending
on the kind of transplant. Kidney transplant recipients tend to be
more similar to the general population than, let’s say, lung trans-
plant recipients. So, in a patient with lung transplant, I’m much
more concerned about what happens if the patient has postopera-
tive sepsis, so I would tend to be more liberal in creating a stoma
diversion.
Discussion
118
AM
I think the overall theme is we are all taking into account the entire
overall gestalt of what’s going on and multiple factors decide. And
I also think as you just alluded to, we need to be weighing the risk
of diversion vs. the risk of leak although in the acute period; the risk
of leak is probably more impactful. However, there is not an insig-
nicant risk related to diversion in some populations.
17 The Role ofDiverting Loop Ileostomy asanAdjunct toLow…
119
© 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_18
18
Laparoscopic vs. Open
Proctectomy forRectal
Cancer
Fleshman J, Branda M, Sargent DJ, Boller AM, George V, Abbas
M, Peters WR Jr., Maun D, Chang G, Herline A, Fichera A, Mutch
M, Wexner S, Whiteford M, Marks J, Birnbaum E, Margolin D,
Larson D, Marcello P, Posner M, Read T, Monson J, Wren SM,
Pisters PW, Nelson H.Effect of laparoscopic-assisted resection vs
open resection of stage II or III rectal cancer on pathologic out-
comes: the ACOSOG Z6051 randomized clinical trial. JAMA.
2015;314(13):1346–55.
Abstract
Importance: Evidence about the efcacy of laparoscopic resec-
tion of rectal cancer is incomplete, particularly for patients with
more advanced-stage disease.
Objective: To determine whether laparoscopic resection is
noninferior to open resection, as determined by gross pathologic
and histologic evaluation of the resected proctectomy specimen.
Design, Setting, and Participants: A multicenter, balanced,
noninferiority, randomized trial enrolled patients between Octo-
ber 2008 and September 2013. The trial was conducted by creden-
tialed surgeons from 35 institutions in the United States and
Canada. A total of 486 patients with clinical stage II or III rectal
cancer within 12cm of the anal verge were randomized after com-
pletion of neoadjuvant therapy to laparoscopic or open resection.
120
Interventions: Standard laparoscopic and open approaches
were performed by the credentialed surgeons.
Main Outcomes and Measures: The primary outcome assess-
ing efcacy was a composite of circumferential radial margin
greater than 1mm, distal margin without tumor, and completeness
of total mesorectal excision. A 6% noninferiority margin was cho-
sen according to clinical relevance estimation.
Results: Two hundred forty patients with laparoscopic resec-
tion and 222 with open resection were evaluable for analysis of
the 486 enrolled. Successful resection occurred in 81.7% of lapa-
roscopic resection cases (95% CI, 76.8–86.6%) and 86.9% of
open resection cases (95% CI, 82.5–91.4%) and did not support
noninferiority (difference, −5.3%; 1-sided 95% CI, −10.8% to ∞;
P for noninferiority = 0.41). Patients underwent low anterior
resection (76.7%) or abdominoperineal resection (23.3%). Con-
version to open resection occurred in 11.3% of patients. Operative
time was signicantly longer for laparoscopic resection (mean,
266.2 vs. 220.6 min; mean difference, 45.5 min; 95% CI,
27.7–63.4; P<0.001). Length of stay (7.3 vs. 7.0 days; mean dif-
ference, 0.3 days; 95% CI, −0.6 to 1.1), readmission within 30
days (3.3% vs. 4.1%; difference, −0.7%; 95% CI, −4.2% to 2.7%),
and severe complications (22.5% vs. 22.1%; difference, 0.4%;
95% CI, −4.2% to 2.7%) did not differ signicantly. Quality of the
total mesorectal excision specimen in 462 operated and analyzed
surgeries was complete (77%) and nearly complete (16.5%) in
93.5% of the cases. Negative circumferential radial margin was
observed in 90% of the overall group (87.9% laparoscopic resec-
tion and 92.3% open resection; P = 0.11). Distal margin result
was negative in more than 98% of patients irrespective of type of
surgery (P=0.91).
Conclusions and Relevance: Among patients with stage II or
III rectal cancer, the use of laparoscopic resection compared with
open resection failed to meet the criterion for noninferiority for
pathologic outcomes. Pending clinical oncologic outcomes, the
ndings do not support the use of laparoscopic resection in these
patients.
18 Laparoscopic vs. Open Proctectomy forRectal Cancer
121
DC
This was a prospective randomized trial that enrolled patients
between October 2008 and September 2013. It was published in
JAMA in October 2015.
This was a noninferiority randomized trial involving 35 institu-
tions in N.America (US and Canada). The primary outcome mea-
sured was “ … efcacy [of obtaining] a composite of
circumferential margin greater than 1mm, distal margin without
tumor, and completeness of total mesorectal excision (TME).” All
three components had to be completed for the surgery to be con-
sidered a success.
The patient population was stage II and III rectal cancer
patients (at or below 12cm from the anal verge). Patients could
have chemoradiotherapy or radiotherapy alone. The surgery was
done 4–12 weeks after completion of radiotherapy by creden-
tialed surgeons who were tested for competency prior to being
able to enroll in the study. Ultimately, after randomizing 486
patients, 240 patients nished in the laparoscopic group and
222 in the open surgery. The primary analysis was a modied
intent-to-treat; meaning if a patient was randomized to a laparo-
scopic group but had an open surgery, they remained in the lapa-
roscopic group (27 of the patients in the laparoscopic arm were
converted).
The Statistical Analysis
• The basic assumption was that there would be a 90% success
in obtaining the primary outcome. So, to obtain an 80% power
the sample size needed to be 480in total, or 240 per arm.
Measuring thePrimary Outcome (3 Criteria)
LAR was done in 76.7% of the patients, and APR in 23.3%, respec-
tively. Conversion to an open procedure was seen in 11% of the
laparoscopic procedures, and conversion to an APR was seen in
DC
122
2.7% of cases. No changes in the open cases. The open cases were
just over 3.5h in duration and over 4h in the laparoscopic group.
Only 77.1% of TME was complete and 16.5% near complete.
The negative circumferential margin and negative distal margin
were 90% and 98% overall, respectively, with no statistical differ-
ence between the groups. However, when taking all three criteria
together, “surgical success” was 86.9% in the open resection arm
vs. 81.7% in the laparoscopic arm. This net 5.2% noninferiority
margin was the source of many discussions and publications sub-
sequently. All that could be said though was that based on this
study, the authors could not allege that laparoscopic proctecto-
mies are not inferior based on the 3-requirement outcome surgical
criteria.
This study was mirrored by another, similar-sized Australasian
study published in the same exact same issue of JAMA [1]. The
studies were designed to be similar. These two studies were sub-
sequently used as an example in a subsequent JAMA publication
illustrating just how confusing it is to interpret noninferiority stud-
ies [2]. The authors state clearly that all a noninferiority trial can
tell you is that an intervention is not worse than a comparator. The
results of this slightly underpowered study simply could not say
that laparoscopic proctectomy is noninferior. The problem here
was that in essence, the study was inconclusive. That is the best
way to word the results. After all of this work, it is just not clear
that there is a difference. Or, if there was a difference, this study
does not have sufcient power to pick it up. So, because of that,
less than one-quarter of the publications that reference this study
accurately and clearly state that the results are inconclusive (of the
130 or so studies that mention either of the two noninferiority stud-
ies above). More than one quarter of publications incorrectly inter-
pret the results of these studies, and more than half are somewhat
unclear of what their conclusions regarding this study actually are.
What actually happened in practice? Mostly, nothing changed.
Some institutions changed their practice, some incorrectly under-
standing the results of ACOSOC Z6051, and some not being able to
justify an additional hour of surgery without clarity on whether lapa-
roscopy is the same or inferior to open surgery. In the end though,
the 2-year disease-free interval of the patients enrolled in ACOSOC
18 Laparoscopic vs. Open Proctectomy forRectal Cancer
123
Z6051 was published, and there was no difference [3]. Take-home
lessons: (1) Non-inferiority studies seem to be a mystery within a
question for some when the result is different than the one you
expect. (2) To ambiguous results do not clarify the question.
References
1. Stevenson AR, Solomon MJ, Lumley JW, etal.; ALaCaRT
Investigators. Effect of laparoscopic-assisted resection vs
open resection on pathological outcomes in rectal cancer:
the ALaCaRT randomized clinical trial. JAMA.
2015;314(13):1356–1363.
2. Acuna SA, Dossa F, Baxter NN.Frequency of misinterpreta-
tion of inconclusive noninferiority trials: the case of the lapa-
roscopic vs open resection for rectal cancer trials. JAMA Surg.
2019;154(1):90–92.
3. Fleshman J, Branda ME, Sargent DJ, Boller AM, George VV,
Abbas MA, Peters WR Jr., Maun DC, Chang GJ, Herline A,
Fichera A, Mutch MG, Wexner SD, Whiteford MH, Marks J,
Birnbaum E, Margolin DA, Larson DW, Marcello PW, Posner
MC, Read TE, Monson JRT, Wren SM, Pisters PWT, Nelson
H.Disease-free survival and local recurrence for laparoscopic
resection compared with open resection of stage II to III rectal
cancer: follow-up results of the ACOSOG Z6051 randomized
controlled trial. Ann Surg. 2019;269(4):589–595.
Discussion
LS
I nd this study very important both in terms of driving clinical
practice and also in reafrming the role of scientic studies in
surgery. This was supposed to become the consecration of laparo-
scopic surgery for rectal cancer on the wave of multiple random-
ized trials which had established the advantages of laparoscopic
surgery for colon cancer. However, the results of this trial were
Discussion
124
inconclusive in establishing the noninferiority of laparoscopic
surgery. Importantly and as you mentioned in your comments, the
results of this trial were basically mirrored by the Australasian
trial which had a similar design. The combination of these studies
could be viewed as a scientic experiment which could be repli-
cated in another laboratory, and this really thwarted my enthusi-
asm for laparoscopic surgery in rectal cancer. One aspect that was
very critical for me as a surgeon was to see that even the recovery
benets traditionally associated with laparoscopic surgery were
absent in this trial where the hospital length of stay was statisti-
cally similar between the 2 study arms. The honest conclusion at
least for the type of patients who had been randomized was that
there was simply no good reason to do laparoscopic surgery,
which was hard to accept for me as somebody who had actually
entered patients into this trial. The oncologic concerns which
emerged when the trial was published have not been substantiated
by subsequent follow-up studies indicating that there was no dif-
ference between laparoscopic and open proctectomy in oncologic
outcomes. In retrospect, it is possible that the creation of a com-
posite pathologic outcome including free resection margin and
complete or near complete mesorectum was not the ideal surro-
gate endpoint to be used for this study. With the advent of robotic
surgery, this study might seem obsolete, but it remains a caution-
ary tale on the primacy of science over our own expert opinions
and the importance of being humble.
DC
The primary issue is that most people do not know what to do with
a noninferiority trial. So, even if the study were perfect with per-
fect results, some people still would have trouble guring out
what the results mean. Ultimately what one could say for sure is
that we cannot say that laparoscopic surgery is in some way bet-
ter. Some said that, “well, we will just go back to hand-assisted”—
which I do not do—and others said that they will just talk to the
patient and tell them that we don’t know if laparoscopic is better,
but we don’t even know if it’s not worse and we’ll just have the
patient decide. Obviously speaking in generalities, I do not think
18 Laparoscopic vs. Open Proctectomy forRectal Cancer
125
the study was understood by must people in the way the authors
meant it, and it took multiple readings to actually gure out what
I could take away for myself when it rst came out. I did not see
that this study actually changed practice to a signicant degree.
LS
When I heard and read that laparoscopic surgery was not noninfe-
rior to open surgery or that the trial was inconclusive regarding
the noninferiority of laparoscopic surgery, these were not intuitive
concepts.
MD
When both studies were released, my thought process was pretty
similar. I distinctly recall reviewing the ACOSOG trial during a
journal club session while I was a resident. Upon closer examina-
tion of the study details, it became evident that the ndings leaned
more toward being inconclusive rather than denitive, raising
concerns about the oncologic safety of laparoscopy in rectal can-
cer. I would say that when I was in training and the trial results
were published, they did not produce a signicant change in clin-
ical practice with the attendings I was working with. Conversely,
the ROLARR trial essentially afrmed the safety of robotic sur-
gery but fell short of demonstrating a clear superiority of the tech-
nique over laparoscopy, which sparked controversy over whether
the investment in robotic technology was warranted. Nonetheless,
there was generally less uncertainty regarding the safety and ef-
cacy of robotic surgery compared to laparoscopy in my opinion.
LS
The trial did change my practice at the time because I became
disillusioned with the idea of doing laparoscopic surgery for rectal
cancer. I had attended meetings, and I had seen videos and talked
to surgeons who had told me that it was easier to dissect the pelvis
Discussion