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C. E. Sharon and J. I. S. Bleier
Perioperative Outcomes
The CoSMIC trial [32] was the rst prospective study to compare oncologic and
perioperative outcomes for patients with SCRLM based on surgical sequence. The
participants found that patients who underwent synchronous resections had higher
rates of post-operative complications when compared to the classic and reverse
resections individually. However, when the complications of each staged approach
were summated, there was no difference in total complications between patients
who underwent staged or synchronous resections (p=0.66). There was also no difference in total critical care (5.6days synchronous vs. 5.2days staged, p=0.92) or
total inpatient stay (16.5days synchronous vs. 16.8days staged, p=0.91). Notably,
patients with staged vs. synchronous resections had no difference in anastomotic
leak rate or stoma formation.
Recommendations
Imaging Evaluation
Initial imaging evaluation of the rectal primary should include a pelvic MRI, or an
EUS if MRI is contra-indicated (quality of evidence: high, grade of recommendation: strong). A CT chest/abdomen/pelvis can evaluate for distant metastatic disease, with a multiphasic CT the modality of choice for optimal classication of
hepatic metastases (quality of evidence: high, grade of recommendation: strong).
PET-CT aids in identifying alternate sites of metastatic disease which would preclude resection of the hepatic metastases (quality of evidence: high, grade of recommendation: strong).
Neoadjuvant Treatment
For patients with borderline resectable or unresectable hepatic metastases, neoadjuvant chemotherapy (NCT) should be administered to downstage the hepatic
lesions and increase the likelihood of subsequent resectability (quality of evidence: moderate, grade of recommendation: weak). Patients who receive NCT
should be surveyed every 2months to assess for disease response and avoid any
disease progression or unnecessary liver toxicity (quality of evidence: high, grade
of recommendation: strong). Perioperative chemotherapy is recommended for all
patients with SCRLM, and those who do not receive neoadjuvant chemotherapy
should be treated in the adjuvant setting (quality of evidence: high, grade of recommendation: strong). There is no consensus on the use of neoadjuvant pelvic
radiotherapy, although short-course radiation may be considered for patients with
resectable liver metastases (quality of evidence: moderate, grade of recommendation: weak).
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301
Surgical Approach
The surgical approach is critically driven by patient characteristics. Primary assessment includes whether there are any symptomatic issues related to the primary
tumor which may need to be addressed rst. However, if the patient is largely
asymptomatic, as in the focus of this chapter, we have more options in deciding how
best to optimize treatment.
Essentially the need to separate the hepatectomy and proctectomy is largely
driven by the complexity of the liver resection, with additional consideration given
to the difculty of the proctectomy and patient factors. Patients with a high burden
of metastatic disease requiring a major hepatectomy should be offered a liver-rst
approach (quality of evidence: low, grade of recommendation: weak). Conversely,
patients with larger or surgically complex rectal primaries are better candidates for
a rectum-rst approach (quality of evidence: low, grade of recommendation: weak).
Patients who would require both a low risk hepatectomy and a straightforward proctectomy are more suitable for a synchronous resection (quality of evidence: low,
grade of recommendation: weak).
A Personal View oftheData
As previously discussed, no prospective studies exist comparing the different surgical strategies for patients with SCRLM, making it challenging to interpret the data.
Additionally, generalizability is difcult due to the heterogenous nature of this disease presentation. However, the management strategy at our institution draws from
the literature and can be consolidated into a few key points:
1. As previously discussed, patients with SCRLM who are evaluated by an MDT
including a hepatobiliary surgeon have a higher resection rate and improved
overall survival (OS) [18, 20]. As such, in our institution all patients with
SCRLM following diagnosis are evaluated by a MDT, including colorectal surgeons, hepatobiliary surgeons, medical and radiation oncologists, radiologists,
palliative care physicians, and pathologists.
2. All patients are treated with neoadjuvant chemotherapy, with a regimen deter-
mined by the medical oncologists in the MDT.Generally, FOLFOX is administered as rst line treatment. Our practice is to re-assess the liver response after
3–4cycles to determine response and limit toxicity if the decision for surgery is
made at that time.
3. Our approach to surgical strategy for patients with rectal cancer and synchro-
nous liver metastases is represented in Fig.25.1. Factors incorporated into our
decision-making include primary tumor symptoms and risk of obstruction,
assessment of resectability of liver metastases, and extent of liver resection
required. Patients who undergo the rectum rst strategy typically have a highrisk of impending obstruction from the primary in addition to a high burden of
metastatic disease requiring a major hepatectomy. For patients without a risk of
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C. E. Sharon and J. I. S. Bleier
No
Low
Primary Tumor Risk of Obstruction
High
Mets Resectability
Assessment of Liver
Mets Resectability
Assessment of Liver
No
Yes
No
Yes
Chemotherapy
Extent of Liver
Resection Required
Major Minor
Or
Or
Diversion
Resection
Palliative CRT
Re-Assess
Resectability
st
or
Synchronous
Liver 1st
Palliation
Liver 1
No
Assess Primary
Symptomatic?
Yes
Palliative CRT
Or
Or
Resection
Yes
Diversion
Minor
Extent of Liver
Resection Required
Major
SynchronousRectum 1st
Fig 25.1 Flow chart depicting our approach to surgical and treatment decision-making for patients with rectal cancer and synchronous liver metastases. This
ow chart is only intended to be a general recommendation. Every circumstance needs to be personalized on patient factors and the availability of personnel
and specialists
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303
obstruction and a high burden of metastatic disease, we typically proceed with a
liver-rst approach. Most patients who require a minor hepatectomy to clear
metastatic disease are candidates for a synchronous approach.
Acknowledgements The authors wish to thank Dr. M.Kenneth Lee, MD for his assistance and
input into the creation of our surgical strategy pathway.
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Who Needs aLoop Ileostomy After Low
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Anterior Resection forRectal Cancer?
L.Cunningham andE.Huang
26
Patient population
Patients after low anterior
resection of the rectum for rectal
cancer
Intervention Comparator
Proximal diversion
with ileostomy
No
diversion
Outcomes studied
Leak rate,
consequences
Introduction
The current surgical standard of care for rectal cancer is restorative anterior proctectomy. The most feared complication after low anterior resection (LAR) is anastomotic leak (AL), with its attendant consequences of pelvic sepsis and poor functional
outcome. The overall published risk of anastomotic leak varies between 3 and 21%
[1]. AL has a reported mortality of 2.1–22% and may require intervention with
methods ranging from interventional radiologic drainage to reoperation [2]. Given
the heterogeneity of what can be dened as anastomotic leak, a common denition
and grading system was proposed by Rahbari etal., based on clinical symptoms and
therapeutic interventions [3]. Later validation of this grading system found that
some leaks, which were subclinical and discovered on routine workup for diverting
ileostomy reversal, were not associated with signicant impacts on postoperative
course [4]. When assessing data on the impacts of AL, it is important to keep this in
mind, as many studies do not document the distinction between AL that do and do
not alter the clinical course.
In addition to immediate impact on a patient’s clinical course, AL can have sev-
eral signicant consequences. Colonic conduit function after anastomotic leak is
L. Cunningham (*) · E. Huang
Department of Surgery, The Ohio State University College of Medicine, Columbus, OH, USA
e-mail: lisa.cunningham@osumc.edu; emily.huang@osumc.edu
© The Author(s), under exclusive license to Springer Nature
Switzerland AG 2023
K. Umanskiy, N. Hyman (eds.), Difcult Decisions in Colorectal Surgery,
Difcult Decisions in Surgery: An Evidence-Based Approach,
https://doi.org/10.1007/978-3-031-42303-1_26
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signicantly worse than in patients without leakage [2]. There is also concern
regarding poorer oncologic outcomes after anastomotic leak, which may include
increased rate of local recurrence and decreased disease-free and overall survival [5,
6]. This increase in cancer recurrence may be due to a delay or abandonment of the
necessary adjuvant chemoradiotherapy [6]. Because of the serious morbidity associated with anastomotic leak, fecal diversion is typically considered worth the risk
to minimize leak rates and the morbidity from such leaks. However, in recent years,
data has emerged on the potential risks and drawbacks of diverting enterostomy,
calling the dogma of mandatory fecal diversion after LAR into question. This chapter presents data that will be helpful in making this decision.
L. Cunningham and E. Huang
Methods
A detailed and updated search of the Embase-Medline and PubMed databases was
conducted for medical literature. The following search terms were employed to
identify relevant articles: (“rectal” OR “colon” OR “colorectal”) AND (“resection”
OR “low anterior resection” OR “proctectomy” OR “anastomosis” OR “coloproctostomy”) AND (“ileostomy” OR “ostomy” OR “stoma” or “enterostomy” OR
“colostomy” OR “diversion” OR “fecal diversion”). The title and abstract of
English-language articles were screened for relevance. Relevant articles were
reviewed in full.
Risks ofDiverting Enterostomy
Despite the widespread use of fecal diversion, it is not without complications. These
complications may include both short- and long-term problems and range from
minor, requiring only local care, to major complications requiring reoperation and
prolonged hospitalization [7, 8]. The most common complication after stoma construction is peristomal skin irritation [9]. While not necessarily dened by most
members of the surgical community as a “major” complication, this can have implications for a patient’s quality of life [10].
A retrospective review of ACS NSQIP data identied multiple complications
that were increased in patients undergoing low anterior resection with fecal diversion [8]. Patients who underwent diversion were found to have a higher rate of
progressive renal insufciency (2.1% vs. 0.8%) without an increased risk of acute
renal failure (1.3% vs. 0.7%). Using a risk adjusted model, this increased rate of
renal insufciency was 2.37 times more likely to occur in patients undergoing fecal
diversion. Furthermore, patients with fecal diversion had a signicantly higher rate
of deep surgical site infections (7.5% vs 5.3%) and a higher rate of 30-day readmission (20.3% vs 11%). Although not specically discussed in this study, the ndings
of renal insufciency and readmission are not surprising following stoma creation,
as one of the most commonly encountered problems with diverting ileostomy is
high ostomy output with dehydration. This complication has a reported incidence of
26 Who Needs aLoop Ileostomy After Low Anterior Resection forRectal Cancer?
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1–16%, is most common 4–8days postoperatively as bowel edema is resolving, and
leads to electrolyte abnormalities, hypovolemia, and readmission [11]. Further out
from the index operation, parastomal hernia occurs at a rate of 15–40% [12].
Diverting ileostomy has also been investigated as a risk factor associated with
anastomotic stricturing, pelvic outlet problems, and LAR syndrome (LARS), which
is a constellation of symptoms ranging from urgency and incontinence to emptying
difculties. This may be due to effects on the temporarily non-functioning rectum
and pelvic oor during recovery and before ileostomy reversal. Two meta-analyses
found both diverting ileostomy and AL to be risk factors for LARS (OR of 1.89 and
1.98 respectively, and OR 1.96 for diverting ileostomy) [13, 14]. Other risk factors
included expected factors such as neoadjuvant radiation and low tumor [13]. Data
from long term follow up of a single randomized trial of loop ileostomy vs. no
diversion for LAR corroborate these ndings. At 12years, patients who had been
randomly assigned to diverting loop ileostomy expressed increased incontinence for
atus and liquid stools, and worse overall low anterior resection syndrome score,
but there were no differences in frequency, clustering, and urgency [15].
While ileostomy reversal is not a technically difcult procedure, it is not without
risk. In a study from Pokorny etal. in 2006, 243 patients who underwent loop ileostomy closure were retrospectively reviewed for complications [7]. An overall complication rate of 19% was identied; 3% had anastomotic leak, 6% developed
signicant postoperative ileus, 1% had bleeding complications, and 9% had wound
infections. In total, 4% of patients undergoing ileostomy closure required reoperation for their complication. Finally, although a diverting ileostomy is intended to be
temporary, some patients do not undergo reversal due to factors that may include
comorbidities or cancer progression. The literature suggests a non-reversal rate of
up 3–32%, with one recent population-based study from Denmark indicating a rate
of non-reversal of 25% at 3years [16–18]. The risks of ileostomy creation clearly
must be balanced against the risks it is intended to protect against.
309
Does Fecal Diversion Decrease Anastomotic Leak Rate?
The key question when considering fecal diversion following low anterior resection
of the rectum is whether diversion changes the rate of anastomotic leak. Numerous
retrospective studies over the years have reported mixed results, with the major
limitation being that surgeons concerned about a LAR anastomosis will always
favor the safety of temporary diversion.
There are several randomized trials of note that can inform decisions on fecal
diversion. Graffner etal. were the rst to design such a trial in 1983, when they
randomized 50 patients to fecal diversion versus no diversion [19]. The rate of AL
was low overall (4% vs. 12%), but stenosis was signicantly more common in the
diverted group (9/25 vs. 2/25), so the authors concluded that diversion should not
routinely be used. The next study, performed in 1997 by Pakkastie etal., randomized 134 patients [20]. They reported a clinically detected AL rate of 16% vs. 32%
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L. Cunningham and E. Huang
reoperation rate in the diverted group, as only one of three leaks required reoperation, compared to all six leaks in the non-diverted group.
Larger randomized studies subsequently addressed this issue. In 2007,
Matthiessen et al. published data from a large multicenter trial in Sweden. 234
patients requiring LAR (tumor located at up to 15cm from the anal verge) were
randomized to diversion via ileostomy or transverse colostomy (n= 116) vs. no
diversion (n=118) [21]. AL was dened clinically, based on examination, endoscopic evaluation, or radiologic evaluation, but radiographically demonstrated leak
(e.g., extravasation of contrast) without clinical symptoms was excluded. AL rate
was signicantly higher in patients in the non-diverted vs. the diverted group (28.2%
vs. 10.3%; p<0.001). Furthermore, there was a signicantly higher rate of reoperation in the non-diverted group with overall 25.4% of patients requiring any reoperation versus 8.6% in the diverted group. Of note, a signicant majority of patients in
both arms of this study had undergone neoadjuvant radiotherapy (81.0% vs. 77.1%;
p<0.001). The authors concluded that defunctioning stoma absolutely does reduce
symptomatic AL after LAR for cancer. Another study, published in 2008 by Chude
etal., randomized 256 patients with tumors located at up to 5 cm from the anal
verge, 120 to diversion and 136 to non-diversion [22]. Postoperatively, 12 of the 120
patients without diversion developed anastomotic leak (10%) vs. only 3 patients in
the diverted group (2.2%). The study authors drew similar conclusions: that diversion was with minimal risk and signicant benet in prevention of AL. Another
small, randomized study performed by Ulrich etal. was reported in 2009, from a
single hospital in Germany [23]. This study design is of note as the authors initially
intended to demonstrate similar risks in the case of diversion and non-diversion. 34
patients with low or mid rectal tumors undergoing LAR with a stapled colonic
pouch were randomized intraoperatively to diversion or non-diversion, after a negative leak test by insufation. Clinical signs were monitored postoperatively, and if
CT demonstrated radiographic leak, the patient underwent laparotomy. Consistent
with prior studies, there was a signicantly higher rate of clinically detected anastomotic leaks in the non-diverted group (37.5%) compared to the diverted group
(5.5%, p=0.02). Due to the study design, all patients who developed a leak in the
no stoma group required reoperation while none of the stoma patients with a leak
returned to the OR.The outcome differences were in fact so dramatic that the study
was terminated after 34 of the intended 40 patients were accrued.
A Cochran Database meta-analysis summarized these results in 2010 [24]. The
meta-analysis found a dramatic reduction in AL using fecal diversion (RR 0.33;
95% CI [0.21, 0.53]). Furthermore, diverted patients had a decreased rate of urgent
reoperation (RR 0.23; 95% CI [0.12, 0.42]). Despite these differences, there was no
signicant decrease in terms of overall mortality (RR 0.58; 95% CI [0.14, 2.33]).
The reviewers concluded that fecal diversion is an effective method in reducing the
rates of anastomotic leak in patients undergoing low anterior resection, and therefore diversion can be offered routinely. Limitations noted include the heterogeneity
of denitions in the studies, and lack of reporting of long-term outcomes.
Since the Cochrane Review was completed, at least one further study has been
performed in a prospective, randomized fashion [25]. Thoker etal. reported in 2014
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