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M. AbouKhalil and S. Liberman
High Resolution Anoscopy
High resolution anoscopy (HRA) is a specialized technique that uses magnication,
lighting, and staining to thoroughly evaluate the anal canal mucosa and identify
suspect lesions. Necessary equipment include a colposcope or an anoscope with
lighting and magnication, an electrosurgical unit, biopsy capability, and staining
usually with acetic acid and/or Lugol’s solution. It is in essence the equivalent of a
colposcopic examination, in the anal canal.
It can be performed in the ofce setting or in the operating room. Ofce evaluations and treatments under local anesthesia are feasible in the majority of cases,
obviating the need for general anesthesia and use of operating room resources. A
recent review of close to four hundred patient experience surveys from a HRA referral center the United Kingdom described good, patient satisfaction and low problematic pain scores with the ofce-based procedures [28].
The uptake of high resolution anoscopy has been much slower than that of colposcopy. HRA is a specialized skill with a learning curve especially relating to
lesion identication [29]. Hillman etal. proposed a minimum of 50 HRA per year
with identication of at least 20 cases of HSIL as a quality assurance metric, and
identied that this skill improves over time [4, 29]. Siegenbeek van Heukelom etal.
analyzed rates of HSIL detection of 7 anoscopists performing HRA in HIV positive
MSM and found that over time, there was an increased HSIL detection rate and
concluded that HSIL detection rate and mean HSIL rate per biopsy can also be used
as a quality assurance metric for HRA [30]. Several attempts have been made to
unify nomenclature and identify certain features that increase the positive predictive
value of picking up HSILs, and identifying areas that need to be biopsied. These
descriptors include amongst others lesion contour, mosaic pattern, vascular punctation/irregular vascularization patterns and Lugol negative staining [31, 32]. There is
also data to support the growing role of articial intelligence for lesion identication in HRA, with the potential for an improved learning curve for lesion identication and better accuracy [33]. While scarce, studies evaluating the impact of
introduction of HRA programs are important. A recent such publication by Squeo
et al. concluded that the establishment of a HRA program was associated with
increased identication and treatment of high-grade anal lesions among women living with HIV [34]. The identication of HSIL was specically higher when HRA
was performed as compared to when anoscopy was performed without the use of a
colposcope or dyes. While the non-randomized historical design and small sample
size limit the denitive comparison between routine anoscopy/EUA and HRA, this
is similar to other studies evaluating this topic [35–37].
Treatment Options
After identication of anal dysplastic lesions, a decision should be made with
regards to both treatment and follow-up. There is a wide spectrum of options available, from observation alone to more aggressive and less performed wide local
excisions.
31 Is High Resolution Anoscopy Superior toDirect Evaluation ofAnal Dysplasia?
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The nding of LSIL lesions generally does not warrant treatment as close to half
of the lesions may regress spontaneously. However, taking into account the patient’s
risk factor prole is important and will impact the decision to treat and how closely
to survey these patients. Upon the nding of HSIL, treatment options include ablative and local therapies. Ablative therapies include electrocautery/hyfrecation, laser
ablation, or infrared coagulation. While all these options are generally similar with
regards to efcacy, there appears to be a superiority of electrocautery when compared to topical treatments with 5-uorouracil and imiquimod with improved
response and fewer side effects. A randomized controlled trial by Richel etal. randomized HIV+ MSM with dysplasia diagnosed on HRA to provider administered
electrosurgical ablation using HRA versus patient applied topical uorouracil or
imiquimod [38]. In 388 patients randomized, electrocautery was better at the treatment of anal intraepithelial neoplasia compared to topical uorouracil or imiquimod, but recurrence rates were substantial with more than 50% of patients having a
recurrence.
355
The ANCHOR Trial
Whether or not treatment of HSIL decreases the risk of progression to anal SCC and
the risk of recurrent HSIL is a matter of debate. This was the main question raised
by the ANCHOR trial.
This eagerly awaited and recently published study is a phase III randomized
controlled trial which included patients enrolled across twenty-ve sites in the
United States [39]. The main objective of the study was to establish the efcacy of
ablation of HSIL lesions in preventing progression to anal cancer, evaluated as a
time-to-event analysis for progression to anal cancer. Patients living with HIV and
aged 35 and older were invited for anal HSIL screening with anal cytology and
underwent physical examination and HRA.All physicians participating in the trial
were well versed with HSIL management and HRA.Patients with a history of anal
cancer or who were found to have anal cancer at presentation were excluded.
Patients with biopsy proven HSIL were randomly assigned to immediate treatment
or active monitoring. For patients in the treatment group, management was selected
by the treating physician from a list of protocol approved therapies and included
both ablative (infrared coagulation, electrocautery and laser) and topical (imiquimod and uorouracil) treatment options. Patients returned for repeat HRA and at
least every 6months after randomization after all HSIL was eradicated. The identication of recurrent HSIL at follow-up mandated treatment until resolution. The
active monitoring arm had repeat HRA every 6months after randomization and
visible lesions were biopsied annually to conrm HSIL persistence and assess anal
cancer progression.
Of close to 9500 patients screened for HSIL, 4459 patients met the inclusion
criteria and underwent randomization. The majority of patients in the treatment
group had ofce-based electrocautery ablation (1862(83.6%)). Overall median follow- up was 27.2months for the active monitoring group and 25.3months. During
the follow-up period, 9 patients developed invasive anal cancer compared to 21
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patients in the active monitoring group, with rates of progression of 173/100,000
person-years (95%CI 90–332) compared to 402/100,000 person-years (95%CI
262–616), respectively. The treatment arm witnessed an impressive 57% (95%CI
6–80) reduction in the risk of anal cancer (p 0.029). Interestingly, the results identied that progression to anal cancer was associated with lesion size but not related to
CD4 count.
Some noteworthy ndings of the study include the high rate of detection of anal
cancer in the active monitoring group with 402 cases/100,000 person-years, which
is much higher than the estimates found in previously published registries [40]. As
the authors discuss, this could be explained by patients history of smoking and
reported male-to-male sexual contact, as well as the screening/preventative nature
of this study. One of the limitations mentioned in the discussion raises the important
point of replicability: the authors question the replicability of the results in settings
where HRA and treatments are performed by less qualied physicians or physicians
with different clinical support systems in place.
The high rate of progression from HSIL to anal cancer in this population highlights the need to set-up screening, treatment, and follow-up algorithms for these
high-risk patients as a public health preventative intervention. There still is a gap in
the knowledge on how to appropriately screen patients-and which patients- for precursor lesions. Anal cytology and anal HPV testing and genotyping may have a role
but have limitations [41].
M. AbouKhalil and S. Liberman
Conclusions
The role high resolution anoscopy plays in the management of anal dysplastic
lesions was reviewed in this chapter. This is an especially important topic to review
at this time given the signicant ndings of the recently published ANCHOR trial,
which showed an impressive reduction in progression to anal cancer in patients with
HIV positive HSIL using HRA-guided investigations and treatments as compared to
active monitoring alone. While there is still no gold standard for screening or treatments of patients with anal dysplastic lesions, HRA is emerging as a central component in the management of patients with anal dysplastic lesions, particularly patient
who belong to high-risk groups like HIV positive patients, MSM, or patients with
gynecological HPV-associated lesions. While HRA is more costly and technically
challenging than routine anoscopic examinations and digital rectal examinations,
this has also been found to be cost-effective in certain situations. A cost effectiveness analysis using a decision-analytic model of the natural history of anal carcinoma and HSIL management strategies concluded that for HIV-positive MSM aged
38 or above, using treatment with adjuvant quadrivalent HPV vaccination is likely
to be cost-effective, while a conservative approach with no treatment is likely to be
cost-effective in younger patients [42]. In this paper, the authors compared a do
nothing strategy, where given not all patients with HSIL develop anal cancer, diagnosis of anal cancer would be based on symptoms alone; active monitoring where
patients would be examined using digital rectal examinations and HRA-guided
biopsy for early anal cancer; treatment for HSIL where patients would be treated
31 Is High Resolution Anoscopy Superior toDirect Evaluation ofAnal Dysplasia?
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357
and followed using digital rectal examination and HRA annually; and treatment
plus adjuvant quadrivalent HPV vaccination where patients would receive the vaccine on top of treatment of HSIL lesions and monitoring. HPV vaccination and
catch-up vaccination in high-risk groups has been shown to reduce HPVseropositivity [14, 42–44]. As data emerges linking increased vaccination with
decreased incidence rates of anal dysplastic lesions, future research will elucidate
and identify high-risk patients who will benet from heightened screening and close
follow-up with HRA [45].
We believe the rst step in the management of patients at risk for anal dysplasia/
SCC should be patient risk stratication. Patients at high risk for nding HSIL
should be offered screening with anal pap smear or HRA.While HRA may not be
available at all institutions given the associated limitations with access to a platform
or lack of training, referral to gynecologic clinic with colposcopic abilities is an
option, or referral to other centers with HRA capabilities is warranted.
With the growing use of HRA, we believe it should be in the armamentarium of
a colorectal surgical practice in areas with high-risk populations.
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Part V
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Benign Colon Disease
Surgical Management Options inSevere
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C Difficile Colitis
AllisonM.Ammann andIanM.Paquette
Introduction
Clostridioides difcile (C. difcile), previously known as Clostridium difcile, is a
spore-forming, anaerobic gram-positive toxin-producing bacillus that is found to be
part of normal large intestinal ora, but can become pathogenic when the microbiome is altered [1]. It is the most implicated cause of antibiotic-associated diarrhea
with approximately half a million infections in the United States each year according to the Centers for Disease Control [2]. Alterations in the normal microbial ora
of the large intestine, most often due to antibiotic use or immunosuppression, results
in increased susceptibility to C. difcile infection [3]. Clinical manifestations of
C. difcile infection (CDI) can range from asymptomatic carriers to mild CDI with
watery diarrhea and crampy abdominal pain to severe, fulminant colitis with multiorgan failure. Severity of infection also depends on the virulence of the strain implicated, with more virulent strains resulting in more severe infections [4]. Recent
collaborative efforts and practice measures including antibiotic stewardship programs have been implemented to reduce the rate of CDI, but it remains a signicant
source of morbidity and mortality for hospitalized patients due to recurrent and
resistant infections [3].
32
A. M. Ammann
University of Cincinnati College of Medicine, Surgery, Cincinnati, OH, USA
e-mail: ammannao@ucmail.uc.edu
I. M. Paquette (*)
Chief of the Division of Colon and Rectal Surgery, University of Cincinnati College of
Medicine, Cincinnati, OH, USA
e-mail: ian.paquette@uc.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_32
363
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A. M. Ammann and I. M. Paquette
Management of CDI relies on cessation of the offending antibiotics, and treatment with oral vancomycin or daxomicin as rst line treatment. The workup
includes laboratory evaluation focusing on presence of leukocytosis (>15 × 103/
mm3) or other organ failure, physical examination, and imaging to evaluate colonic
dilation or inammation. Most patients, approximately 95–99%, with CDI will not
require surgical intervention. Surgical intervention is reserved for patients with
colonic perforation or severe colitis that does not improve with medical therapy and
the decision to operate on severe CDI is provider-specic and often guided by experience [3, 5]. The historically recommended and most commonly performed procedure for severe-complicated C. difcile colitis is timely total abdominal colectomy
(TAC) with end ileostomy as this procedure provides optimum source control [3, 6,
7]. Unfortunately, mortality rates following this procedure remain high and range
from 34% to 57% with predictors of mortality including patient factors such as age,
immunosuppression, and preoperative clinical signs of end organ damage [3, 8].
Additionally, patients undergoing laparotomy and TAC often require permanent end
ileotomy, which can be associated with signicant morbidity [9]. Thus it is important to proceed to surgical intervention at the correct time, as surgery too early can
lead to unnecessary morbidity, where surgery performed too late increases the likelihood of mortality.
The previous edition of this text focused on the indications for surgical management of CDI and focused primarily on TAC with end ileostomy, which has been
repeatedly shown to be superior to segmental colectomy. An alternative approach to
the treatment of severe CDI is a loop ileostomy (LI) with antegrade colonic lavage
using high-volume polyethylene glycol or electrolyte solution followed by postoperative antegrade vancomycin enemas. This was originally described by Neal
etal. in 2011. The authors demonstrated that LI was a safe alternative operative
approach in the surgical treatment of severe, fulminant CDI with evidence of
decreased mortality in those receiving LI and colonic lavage compared to TAC [9,
10]. However, strong evidence supporting the safety and efcacy of LI is lacking
and controversy still exists regarding the benet in mortality of this approach compared to TAC with end ileostomy. The patient population of interest is indicated in
Table32.1.
Table 32.1 PICO table
P (Patient Population)
Patients with severe
Costridioides difcile colitis
I (Intervention) C (Comparator)
Surgery No surgery Morbidity, mortality,
O (Outcomes)
quality of life
32 Surgical Management Options inSevere C Dicile Colitis
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365
Search Strategy
A comprehensive search of PubMed and MEDLINE was performed to identify all
English-language publications related to the operative management and outcomes
related to C. difcile colitis from January 1st, 2015–August 1st, 2022. Published
information was graded according to the GRADE guidelines. Key search terms
included the following: “Clostridioides difcile”, “Costrisium difcile”, “surgery”,
and “outcomes”. Evidence was generally moderate to low due to the retrospective
nature of the published results available. Case reports, and reviews not containing
original data were also excluded.
Results
Overall evidence is on this subject was low due to the retrospective nature of these
studies with no identied randomized controlled trials (RCT) (Table 32.2). We
updated the available clinical evidence presented since the previous version of this
chapter was published. No high-level evidence regarding surgical technique is available. In fact, recent RCT aimed at examining outcomes between TAC and LI terminated early due to paucity of eligible patients or slow accrual [11]. The overall
mortality rate for patients with severe CDI managed surgically was found in the
studies we examined to be between 30% and 32%. Mortality for patients undergoing TAC ranged from 23% to 40% while the mortality for patients undergoing LI
was between 17% and 36%.
Ferrada etal. retrospectively compared the outcomes of patients with CDI in this
multi-center study following surgery (TAC vs LI) and found that adjusted mortality,
controlled for pre-procedure confounders, was lower in the LI group (17.2% vs
39.7%, p=0.002) [10]. This was the only study examined in this text to show a
mortality benet for LI and antegrade colonic lavage. Hall etal. queried the ACSNSQIP database for patients undergoing LI or TAC.In this study, which is the largest to date comparing outcomes between LI and TAC in patients undergoing surgery
for CDI, the authors found no mortality difference between the two approaches.
However, patients who underwent LI had lower median operative times (1.6h vs.
2.2h, p<0.0001), experienced fewer post-operative complications (72% vs 87%,
p = 0.021) and had less frequent blood transfusions (19% vs 54%, p < 0.0001).
Interestingly, the reoperation rates were similar for patients undergoing LI compared to TAC (9% vs. 11%, P>0.05) [12]. Fashandi etal. retrospectively reviewed
patients at a single institution who underwent either TAC or LI and colonic lavage
for CDI and found no difference in mortality (30% vs. 23%, p=1.0) [13]. Although
this study was limited by a small sample size and single institution analysis, a
majority (83%) of patients who underwent LI had return of intestinal continuity and
all had colonic preservation. Juo etal. examined the Healthcare Cost and Utilization
Project Nationwide Inpatient Sample (NIS) for patients undergoing either TAC or
LI in the US to evaluate trends in the surgical treatment of fulminant C. difcile
colitis. They found that the proportion treated with LI doubled over the study period
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