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13 Fecal I nco nt ine nce
211
Sphincter Repair
Key Concept: Sphincter repair still plays a role in the management of incontinence, though long-term results remain
disappointing. Preoperative biofeedback may be considered
to improve results.
For patients with an anterior sphincter defect, typically
from childbirth trauma, an overlapping sphincter repair has
been advocated. The initial enthusiasm for this operation has
been tempered with the realization that long-term results
tend to be abysmal [ 19 ]. A systematic review of 16 studies
with nearly 900 patients concluded worsening results over
time with no predictive factors identifi ed [ 20 ]. Technical fac-
tors have been blamed for these poor results, but even with
verifi cation of an intact overlap, the long-term results remain
poor. Even when pudendal nerve terminal motor latency is
not affected, the results tend to be disappointing. The exact
reason remains elusive. Since some women have no issues
with fecal control until years after the delivery trauma, there
may be intrinsic damage to the sphincter besides the structural damage. Hence, when a sphincter is damaged during
childbirth, the scar and fi brosis may eventually interfere with
optimal function even if the sphincter has been repaired and
the repair remains intact.
In many countries sphincter defects are not repaired in favor
of sacral nerve stimulation. However, there may still be a place
for this procedure. It is a relatively easy procedure, requiring no
extra equipment, lower cost than many other procedures for
fecal incontinence, and can be performed globally in any OR.
In a young woman who has a signifi cant symptomatic childbirth injury, our unit prefers a sphincter repair as the initial recommended treatment. Additionally, many women may be
averse to having a permanent device implanted (sacral nerve
stimulation or artifi cial bowel sphincter) at a young age. Full
disclosure regarding the possibility of poor long-term results is
also part of the preoperative discussion. Another consideration
is that many women who have had fecal control issues for any
length of time have forgotten how to contract their anal sphincter muscles. They may pull their buttocks together to avoid
stool loss. Therefore, planning some lessons regarding anal
sphincter movement (physical therapy retraining) before the
repair and then after the surgery has healed may be benefi cial.
In an attempt to improve long-term results, our center
proposed using a biological graft to reinforce the two overlapped ends [ 21 ]. In a pilot study of ten women, there were
no complications. These patients were compared to ten
matched patients who had undergone a traditional overlapping repair. At 1 year, signifi cant improvement in continence
and quality of life was seen over baseline and compared to
results from traditional repair. The question is whether these
improvements will be sustained as these patients age and that
will require long-term studies.
For young women who have an obstetrical injury, timing
is frequently questioned. If we see them within weeks of the
injury, it is important for the tissue to fully heal before any
repair is attempted. This typically takes 3–6 months for the
scar to become soft and pliable. For women who desire more
children, the questions comes up regarding repair now versus waiting until after they have fi nished having all their
children. This is discussed extensively with the patient along
with the infringement that the fecal incontinence has on their
quality of life. It is unclear if waiting versus immediate repair
makes a difference, so it is a decision that the patient will
make. However, if they have more children, they should still
have a C-section to avoid further injury to their anal muscles.
I have seen women with a sphincter injury who defer repair
and then have another vaginal delivery. On many occasions
they return with worse problems such as no muscle movement in their entire perineal area or further injury of the muscle complex.
I prefer a full bowel preparation before this procedure and
the prone position. However, successful results have been
accomplished without a bowel prep or in the lithotomy position. A Foley catheter is inserted. For the procedure, typically a transverse incision is made across the perineal body.
The ends of the muscle must be dissected out to allow overlap. There is some literature that end-to-end repair may be
superior [ 22 , 23 ], but I still prefer a careful overlap using 2-0
polydioxanone. While the internal and external muscle can
be separated and repaired individually, I prefer to overlap
them together in bulk. Another unanswered question is if a
levatorplasty will improve the longevity of a repair. A word
of caution regarding the levatorplasty is that it may lead to a
bridge of tissue across the vagina and dyspareunia. Therefore,
I will add a levatorplasty if it does not narrow the vagina,
lead to a bridge of tissue that feels like a tight band across the
posterior vagina, and not require extensive further dissection
of tissue. I take special precaution when raising the fl ap of
anorectal skin and mucosa to avoid making the fl ap too thin
(or it will become ischemic) and also avoid using excessive
trauma with pickups, which would pinch this fragile area.
Irrigation with antibiotic solution is used throughout. The
horizontal incision is closed transversely over the anal
sphincter and vagina. I typically will leave the central portion open for drainage. Invariably the wound rarely heals in
a straightforward manner when the skin is closed. The most
important thing is to make sure there is an outlet for drainage
of any fl uid that may be trapped or is a transudate into the
deep wound area. The goal is to avoid drainage into the anal
area that could lead to a fi stula or destroy the muscle repair.
I try to make the environment such that the fl uid drains out
the perineal area or closer to the vagina. Drains are used
selectively (by me, although one of my partners always uses
a drain) particularly if there is a lot of dead space. In the
postoperative period up to about 3 weeks, if fl uid becomes
trapped beneath the repair, it is crucial that it is evacuated to
avoid an abscess. To this end the wound is examined if
212
T.L . Hull
possible on a weekly or 2-week basis in the outpatient clinic
to ensure fl uid does not become trapped. After the surgery, if
possible I admit the patient for 1–2 days. Many insurance
companies will only approve 23-h stay, so adjustment to this
time frame is needed.
There is no clear evidence as to postoperative care, so
experience- versus evidence-based approach is taken. I
administer IV antibiotics while the patient is hospitalized
and then oral antibiotics for 5 more days. Women prone to
vaginal yeast infections also are given an oral antifungal
agent during this time. Postoperative bowel management is
crucial and often neglected. Besides exogenous fi ber and a
regular diet, I ask patients to ingest 30 cc of mineral oil daily,
warning them that they will have an orange discharge on
their underclothes. If they do not have a stool by 3 days after
starting an oral diet, then they are advised to take milk of
magnesia, one ounce twice daily until they stool. I prefer
very soft stools versus a hard stool bolus that is diffi cult to
pass. They can take a shower, but no baths or sitz baths to
avoid excessive skin maceration for 2–3 weeks. Leaving the
anal skin incision open over part of the perineal body infers
that it will heal by secondary intention from the bottom up.
Warning patients that the wound may be open for 4 weeks
and they may note blood with wiping or on their underclothes avoids alarming calls by patients. I allow them to
walk and sit on the fi rst postoperative day and also ask them
to avoid lifting over 20–25 lb for 4–6 weeks as lifting or
excessive exercise inadvertently will bear down on the pelvic fl oor and may put pressure on the repair. I also ask them
not to sit on a doughnut to avoid pulling the buttock cheeks
apart and hence pull on the repair.
Artifi cial Bowel Sphincter
Key Concept: While still plagued by increased complication
rates, ABS may be an option for select, motivated patients.
Several technical tips are useful to minimize the morbidity
associated with ABS implantation.
There is still a place in the surgical armamentarium for
the artifi cial bowel sphincter. This treatment may be offered
to patients born without a functioning anal muscle, those that
have traumatic loss of the anal muscle, or those that fail or
are not candidates for other treatments. Even after the learning curve, this procedure has a signifi cant infection rate,
reported to be around 40 % in two single-institution studies
[ 24 , 25 ]. One unit that divided their cases by experience
reported a 50 % failure rate for the fi rst 12 cases but 80 %
success in the last 25 [ 26 ]. Most recently this center reported
implantation via the vaginal approach and a 22 % rate of
adverse septic events in 32 patients. Of note, these were in
women with severe damage and scarring of the perineum,
and a vaginal approach was chosen due to concern regarding
the feasibility of implantation via the perineal route [ 27 ].
Whether routine transvaginal implantation in women will
improve results will need further study. Even with the high
complication rate, up to 50–70 % can achieve success—
defi ned as an activated working device and improved continence [
25 , 28 ] in centers with experience in implantation.
Additionally, all studies report signifi cantly reduced fecal
incontinent episodes and improved quality of life in those
with an activated device [
25 – 28 ]. One further issue noted in
patients with an activated device may be empting diffi culties
reported in 28–57 % [ 26 , 29 ]. This may be due to a new
“dam” on the rectum where it was freely open to evacuate
before or overall congenital problems affecting rectal
function.
I continue to offer this treatment to appropriate patients. I
discuss in depth the issues of infection, complications, and
explantation. While these are serious issues, they are almost
never life-threatening. I also discuss the problems with evacuation that require considerable counseling and typically
laxatives or enemas to ensure adequate evacuation. The
device initially is not activated after implantation to allow all
wounds to heal. During this time, I still recommend 30 cc of
oral mineral oil to prevent impaction as the device itself coupled with postoperative swelling and use of narcotic pain
medication may lead to new evacuation problems. If a patient
has uncontrollable diarrhea, the mineral oil is discontinued,
but otherwise I recommend that it be continued for two more
weeks beyond the 6-week mark when I activate the device. I
fi nd in patients with severe fecal incontinence, especially
when a stoma is their only alternative, the high failure rate
does not deter them regarding this device.
Some technical tips that I have found helpful include, during the procedure, employing two teams for implantation,
one for the perineal portion to implant the cuff and the other
team for the abdominal portion to implant the pump and balloon. There has been speculation that this will reduce rates of
infection, and while I do not know if this is true, it does
reduce the operative time. I make sure the cuff around the
anus when in the open position is just barely snug when buttoned, but not too tight to help lessen evacuation problems. I
also insist on an experienced company representative being
present with entirely new inventory in every size of each part
of the device for several reasons. Since limited numbers are
done in a year, I do not like to use inventory that has been on
our hospital shelf for an extended period of time. At one
point in my past experience, I had diffi culty activating the
pump on three consecutive cases, and it was theorized that
shelf stock, which was up-to-date but not new, may have
been the culprit. I additionally want an experienced company
representative present to answer the multiple questions that
nurses usually have about preparation of the device. This is a
complex procedure with many steps, and even the experienced nurses will not be involved in many cases per year. I
use a full bowel prep before the surgery, as one study showed
that an independent risk factor for infection was short time
13 Fecal I nco nt ine nce
213
from implant to fi rst bowel motion [ 24 ]. Patients receive IV
antibiotics before the implant that cover gram-negative,
gram-positive, and anaerobic bacteria. They continue these
antibiotics until discharge, which can be up to 5 days in the
hospital. They then go home on oral antibiotic to total 10
days IV plus oral. The night before the procedure, they also
wash with antiseptic soap. Women are cautioned not to shave
their pubic hair for 5 days prior, and in the OR, hair is clipped
and not shaved over the suprapubic region. Ice packs are
used on the perineal wound for 24 h postoperatively, and
bacitracin topical ointment is applied to the perineal wound
directly after surgery and for the fi rst week.
If an inadvertent opening is made in the rectum while
developing the plane anterior to the rectum for cuff
placement, then the insertion is abandoned. To attempt to
avoid this situation, the rectovaginal septum in women or
anterior anal area in men must be developed deeply enough
(I prefer ~6 cm) to allow subcutaneous tissue to easily cover
the device and be closed in layers prior to skin closure. If a
vaginotomy occurs, in selected situations if I can place the
device well cephalad to the vaginal opening, and the vaginotomy is repaired and then the anal cuff inserted. All skin
incisions are closed in layers with polyglactin suture. I also
irrigate the perineal wound with antibiotic irrigation during
the procedure. Placement of the cuff from the abdominal
incision into the labia or scrotum can be diffi cult. It is crucial
to develop the tract via the abdominal incision with a large
Kelley clamp and make it large enough to allow the device to
easily slide to the desired level of the scrotum or labia. The
activation button should be turned to face laterally, and the
tissue just cephalad to the pump is snugged down with a
suture to ensure the pump does not migrate toward the
abdominal incision or change orientation. Care is taken when
placing this suture to avoid needle penetration of the tubing.
Which side to place the pump is chosen in the offi ce preoperatively with the patient’s input to ensure ease of manipulation of the pump with their preferred hand. Morbidly obese
patients that cannot reach their labia or scrotum or patients
with debility in hand coordination should be cautioned
against an ABS.
Long-term activity restrictions are controversial. I ask
them to avoid riding a bike but otherwise have not been
restrictive. Avoidance of anal intercourse is also discussed.
Sacral Nerve Stimulation (SNS)
Key Concept: SNS has an evolving role in these patients. The
ability to observe improvement during a test phase makes
this is an attractive alternative.
While considerable experience has been reported since
1995 with sacral nerve stimulation (SNS) for fecal incontinence, it is one of the newer modalities available in the
United States being FDA approved in 2011. The exact therapy has been used for urinary incontinence for the past two
decades, and there is extensive data published in that arena.
A unique aspect to SNS is that the device can be tested as
stage 1 of a two-stage procedure to assess improvement
before a permanent device is implanted (Video 13.1 ). Stage
1 can be done in two ways. Currently in the United States, a
tined lead is inserted (typically in the S3 sacral foramina
under fl uoroscopic assistance) and connected to a temporary
neurostimulator device. If there is a reduction in 50 % of
incontinent episodes, then this lead is disconnected from the
external neurostimulator device and a new connection is performed to a permanent neurostimulator device that is
implanted in the subcutaneous fat of the upper buttock
region. If there is no improvement, the lead can be removed.
In many centers outside the United States, and gaining in
popularity with urologists worldwide, is the alternative stage
1 method called percutaneous nerve evaluation (PNE). For
PNE a temporary thin wire is threaded into the S3 foramen
and secured at the exit site with tape onto the skin. It is connected to the same temporary neurostimulator device, and
the patient is monitored for improvement in fecal incontinent
episodes. If therapeutic success is reached, the temporary
wire is removed and the permanent lead and permanent
neurostimulator is implanted as the second stage of the procedure. This can occur at a later date after the PNE wire is
removed.
At this point, I do not fi nd the latter method as attractive
because the PNE wire can easily become dislodged and the
therapy deemed unsuccessful. Also the implanted tined lead
may not be exactly in the same position as a successful PNE
wire and that also can lead to failure when the permanent
device is inserted. The popularity of PNE is related to the
fact that it costs less to insert and can be removed easily. If
successful, the plans for placement of the permanent device
can be readily scheduled or delayed to the far future. With
the permanent implantation of the tined lead during stage 1,
the lead should be internalized or removed within 2–3 weeks
to avoid infection. Compared to the ABS, the infection rate
overall is less and reported to be 11 % in the monitored study
for FDA approval in the United States [ 30 ].
Recently, success for therapies involving fecal incontinence has been defi ned as 50 % reduction in fecal incontinent
episodes, which concurs with FDA requirements for approval
in the United States. It is debated whether this truly improves
a patient’s suffering with fecal incontinence, but most results
are reported in this fashion. In the multicentered prospective
study conducted under a strict protocol for FDA approval
mentioned above, 285 patients were screened and 133 met
criteria for stage 1. Of those, 120 were successfully implanted
during stage 2. At 1 year, 83 % had >50 % reduction in incontinent episodes [
( p < 0.0001) [
31 ], at 3 years 86 % [ 32 ], and at 5 years 89 %
33 ]. Overall, approximately 40 % were totally
continent at these time points. Looking at the data another
way, the number of incontinent episodes per week at baseline
214
T.L . Hull
before this treatment was 9.1. At 1 year it dropped to 1.9 [ 31 ]
and 1.7 at 5 years ( p < 0.0001) [
had left the study, but only 15 exited due to lack of effi cacy or
patient-related issues with the device [
also found to signifi cantly improve and remained sustained
over the study period [ 34 ]. Overall, these results mirror other
reports from centers outside the United States regarding the
improvement in continence and quality of life [
Improvement is also seen when studies are done that
include patients with an anterior sphincter defect [ 39 ]. Based
on relevant studies, a consensus panel felt SNS could be
offered to patients with 120° external sphincter defect [ 40 ].
Additionally this panel felt SNS was a good option to treat
patients with combined fecal and urinary incontinence.
Unsolved issues in implantation include use of antibiotics. There are many protocols used by various centers. After
an informal poll of urologists at our institution and various
centers implanting SNS, we have elected to use cefazolin
(Ancef R ) for stage 1 and vancomycin and gentamicin for
stage 2. Another unsolved issue is whether or not to impose
activity restrictions in the immediate postoperative period
and long term. While we do not advise any long-term restrictions, after stage 1 we ask them not to shower, reduce physical activity to avoid pulling on the wire or dislodging it, and
keep the device beneath clothing.
33 ]. At 5 years, 44 patients
33 ]. Quality of life was
35 – 38 ].
Repeat Overlapping Sphincter Repair
Repeat overlapping sphincter repair is a feasible option when
a defect is identifi ed on anal endosonography. With US
approval of SNS and injectable agents—combined with the
realization that a sphincter defect does not preclude
“success”—a repeat repair does not look as attractive. If they
are eligible for SNS, I would favor that treatment.
Managing Expectations of Outcome
Perhaps one of the most important aspects of working with
patients who experience fecal incontinence is setting realistic expectations. The notion of perfect continence like they
probably experienced in their youth is rarely obtained. The
goal should be improvement, particularly in their quality of
life. Attempting to fully explain in layman terms the advantages and disadvantages of each procedure is challenging;
therefore, most patients will rely on our assessment of their
individual problem and our recommendation for improvement. Again, the concept that a combination of procedures
may be necessary for improvement, and viewing incontinence as a chronic disease requiring lifelong adjustments,
should be introduced.
Controversies in Fecal Incontinence Management
Does Age Infl uence Choice of Treatment?
All treatment for fecal incontinence should be individualized
and tailored to the patient. Generally, as stated above, we have
advised young women with an obstetrical injury to have their
sphincter repaired as the initial procedure. However, this may
not be the recommendation at other centers—particularly outside the United States. When compared to younger patients
with a median age of 38 years, older patients (median age 56)
reported subjectively worse outcomes and tended to have worse
incontinence scores and quality of life measures [ 41 ]. This
study was based on a postal survey, which had a 55 % useable
response rate and no preoperative scoring tool as a comparison.
The introduction of injectables and SNS may change the algorithm, but anecdotally I have performed a sphincter repair on a
woman in her late 80s with a satisfactory result. I prefer to look
at their physiologic status and their stool and bowel consistency. In a woman with no muscle movement and typically
loose stool that cannot be improved, I feel will fare poorly with
a sphincter repair—particularly if older. Alternatively, whether
SNS will be offered to older patients (older perhaps meaning in
their 80s) remains to be defi ned. For an active patient, I believe
age will not be the limiting issue.
What Findings on Testing Infl uence
Certain Choices?
The history and physical exam is usually the most important
determinant in providing a tailored treatment option. The
most important test is usually anal endosonography because
a defect in the muscle may infl uence what is recommended.
I may be hesitant to recommend SNS for a patient who
has had a traumatic pelvic injury and hence no spinal refl ex,
but that again is not defi nite, as the fi rst stage can be done to
look for a response when the sacral foramina are
stimulated.
For patients that seem to have a component of irritable
bowel syndrome and fecal incontinence, SNS may be the
preferred recommendation. We do not know how SNS truly
works, but an intriguing study showed that chronic stimulation seems to affect the learning and reward center of the
brain [ 42 ]. This potentially could have a positive effect on
the mechanism of irritable bowel syndrome, but defi nitely
more studies are required to confi rm these thoughts.
Is a Stoma Ever the Best Option?
Absolutely! For some patients a permanent stoma is their
best option—they may simply not want to hear or believe
13 Fecal I nco nt ine nce
215
that. This includes patients who fail all therapy or are not
candidates for lesser therapies for various reasons. While a
stoma is usually my treatment of last resort, this allows
patients to function outside their home. Additionally patients
who want the most reliable “fi x” may opt for a stoma since it
involves one procedure with the most predictable outcome.
Consultation with an enterostomal therapist is also helpful to
answer questions and to mark the patient before surgery.
After surgery, as equipment requires adjustment, these nurses
can continue to answer questions and provide specialized
advice. I try to steer wheelchair-dependent patients toward
this option, and marking in the wheelchair is crucial for the
correct position.
When patients choose this option, it is paramount that the
best stoma be constructed. If this requires an open procedure,
the approach (laparoscopic versus open) should not compromise the end result. I typically attempt to perform an end
colostomy in the left colon making sure the bowel used is
soft and pliable, or distal transverse colon if necessary, to
attain the best stoma.
Defects in the Internal Sphincter Only or Other Types of Lateral Sphincter Defects
Select patients have defects in the internal sphincter only that
lead typically to debilitating fecal leakage. Most commonly
I see these patients after an internal sphincterotomy that
changes the contour of their oval anus, leading to a deep
crevice that allows escape of typically liquid stool or mucus.
While I have no data to support this approach, I favor trying
to re-approximate the internal sphincter in order to change
the topography of that area.
The exact approach to address the lateral internal sphincter defect is a separate dilemma, as I have found that there is
usually a thick scar over the area. I have tried a semicircular
incision at the anal verge and creating a fl ap to the sphincter
and repairing via this approach, but I have almost abandoned
this, as the scar over the area of repair typically will become
ischemic and necrotic. Therefore, when faced with these
patients, I presently will incise longitudinally over the scar
and dissect until each limb of the internal sphincter is identifi ed. I try to limit the amount of dissection because the goal
is to change the contour and eliminate the divot while trying
to limit the amount of dead space created.
A similar type of topography issue can be seen in select
cases after a fi stulotomy or traumatic (slice/stab type) injury
of the anus. This type of injury is not located anteriorly, and
repair is not as straightforward as the typical anterior overlapping sphincter repair done for an obstetrical injury. Again
this is typically a contour problem, and the goal is usually to
create a smooth contour that will not allow liquid stool or
mucus to seep through. Anal endosonography is crucial in
providing a road map prior to surgery. A linear incision is
made over the scar and the muscle ends are identifi ed. In
specifi c cases, especially if the defect in the sphincter is close
to 180°, the scar (rather than the retracted muscle) can be
used as one end of the circular repair, which is sewn to other
end of muscle to improve function. I attempt to bring muscle
across the anterior or posterior aspect of the anal circle where
the sphincter would be and thus try to orient the scarred portion on the lateral sides. This seems to provide a more oval
contour.
If optimal improvement is not seen, injectable therapy
may be a consideration, although I have not used it in this
type of patient as of yet. Also SNS or ABS may be a consideration if all other forms of therapy are unsuccessful.
How to Manage Concomitant Pelvic Floor Disorders (i.e., Rectal Prolapse, Rectocele) if Repairing the Sphincter
Typically I favor repair of associated pelvic fl oor disorders
when a sphincter repair is planned in most instances. Over 10
years ago when our results were examined, there was no difference in outcome improvement if a sphincter repair was
done at the same operation combined with an anterior pelvic
procedure (with the urologist or urogynecologist) versus a
sphincteroplasty alone [ 43 , 44 ]. Combined surgery with the
anterior pelvic surgeons requires a team approach and may
involve a position change if you prefer to repair the anal
sphincter in the prone position. Therefore, the anesthesiologist must also be agreeable to the position change.
I have performed several sphincter repairs when an
abdominal procedure was done at the same setting for rectal
prolapse repair. These were typically more diffi cult and very
bloody repairs, such that I currently hesitate to perform
simultaneous repairs in this setting as rule. Most women
have improvement in their anal sphincter when their rectal
prolapse no longer chronically stretches the muscle, so I wait
and reassess at about 6 months.
Future Treatments
Key Concept: Several treatments have been reported that are
currently not available in the United States.
Magnetic Ring
One described treatment involves a titanium wire containing
magnetic beads threaded around the anus. When the pressure
in the rectum during straining reaches a certain threshold, the
magnetic beads spring open allowing defecation. Currently
216
T.L . Hull
one company (Torax Shoreview, Minn) makes the device,
which they have called Fenix
TM
. They have conducted a feasibility study with this device [ 45 ] demonstrating ease of
implantation and no requirement for adjustments by the physician or patient. Of 14 implanted devices, 3 were removed.
Short-term results showed a decrease of the mean number of
weekly incontinent episodes from 7.2 to 0.7. One group outside the United States that participated in this study compared their results in 10 patients implanted with the magnetic
ring matched to 10 with an ABS [ 46 ] and 12 with the mag-
netic ring matched to 16 with SNS [ 47 ]. They found that the
magnetic ring was as effective as SNS in improving continence scores and quality of life with similar morbidity.
Regarding ABS, the magnetic ring patients had similar quality of life and less constipation versus ABS. It did show that
the ABS patients tended to have better incontinence scores
( p = 0.0625). This device certainly looks promising with a
relatively simple method of implantation and acceptable and
comparable results compared to other treatments [ 48 ].
Further studies are needed to defi ne its role and gain FDA
approval in the United States.
Anal Sling
For urinary incontinence, slings have been used extensively
to improve control. Similarly a U-shaped sling has been
devised that goes behind the lowest part of the anorectum
with the ends being brought out through small incisions lateral to the vagina at the medial notch of the obturator foramen. The tension is adjusted on the posterior anorectum and
the excess “arms” clipped at the skin and the skin closed over
them, to create a sling like support of the anus (Patents/
US20110046436). A multicenter study has been completed
and is awaiting adequate follow-up prior to publication of
results.
Posterior Tibial Stimulation
Posterior tibial stimulation of the posterior tibial nerve at the
medial ankle either by needle or surface electrode has been
proposed to treat fecal incontinence. It is currently being
studied for urinary incontinence in the United States and not
approved or trialed as of this writing for fecal issues in the
United States. There are eight studies from outside the
United States, and all vary regarding treatment protocol (i.e.,
frequency of stimulation (20–30 Hz), timing (daily, alternate
days, weekly, every other week), and duration (20–30 min)),
but all use external portable pulse generators [
studies had 60 % of patients reach the primary endpoint they
set before starting and defi ned these patients as having a successful outcome. Again, all of these published studies all had
49 , 50 ]. Five
varied protocols for treatment. A recent randomized, blinded,
sham-controlled study of 144 patients from nine centers
failed to show any benefi t versus sham particularly in median
number of fecal incontinent episodes per week [ 50 ]. This
well-conducted study does cast some doubt toward its
usefulness in individuals with fecal incontinence.
Summary Pearls
Fecal incontinence is a complex chronic disease. Many treatments are available, and individualization typically based on
history and sphincter integrity currently aids in making treatment choices. Treatment choices revolve around conservative, nonsurgical, and surgical treatments (see Table 13.2 ).
The surgical procedures aim to correct a defect, augment the
sphincter, or change the “wiring” of the pelvic area. There is
no panacea for treatment—which is a key concept. The
Cochrane review for fecal incontinence in adults seemed to
compare all treatments together, which proved to be unhelpful for providing guidance due to many reasons including the
poor design of most trials [ 51 ]. But more importantly, the
authors did not recognize that a crucial part of the question is
which patient characteristics should steer health-care providers toward which treatments. More importantly, it failed to
identify the reality that a combination of treatments may provide the best outcome. With all these unknown variables,
future study should include discovering which patient characteristics are important to give optimal results for each individual therapy. A more diffi cult aspect for future study is
Table 13.2 Treatment options for fecal incontinence
Conservative (important to provide precise written instructions
regarding the conservative treatment advised for the patient)
– Control diarrhea
– Address anal skin problems
– Counsel on avoiding excessive wiping
– Dietary manipulation
– Enema therapy
Nonsurgical
– Physical retraining (biofeedback)
– Anal plug
– Radiofrequency energy (SECCA
– Injectables (NASHA Dx
Surgical
– Sphincter repair
– Artifi cial bowel sphincter
– Sacral nerve stimulation
– Diverting stoma
Future treatments
– Magnetic anal ring
– Anal sling
– Posterior tibial stimulation
R
)
R
in the United States)
13 Fecal I nco nt ine nce
217
Fig. 13.7 My current algorithm when considering treating patients
with fecal incontinence. ABS artifi cial bowel sphincter, SNS sacral
nerve stimulation, Tx treatment, FI fecal incontinence
what combination of treatments will provide the best outcome for individual patients. In the meantime, providers
treating these patients must be familiar with all treatments
and prepared to offer various treatments, perhaps in combination, to optimize quality of life with the caveat that this is
a lifelong problem and adjustments in treatment approaches
will be necessary (Fig. 13.7 ).
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Local Treatment of Rectal Cancer (TEM Versus TAMIS Versus Transanal Excision)
John H. Marks and Harry Reynolds
Key Points
• Local treatment options for rectal cancers vary
markedly depending on the following: level of cancer in rectum, extent of lymph node involvement,
and the T stage of the cancer.
• Initial thorough evaluation of the rectal lesion is
critical and must assess position, level in rectum,
size, ulceration, and clinical stage of the cancer and
must include a digital rectal exam.
• Endoluminal surgery combined with neoadjuvant
therapy offers an exciting option in select rectal
cancers.
The online version of this chapter (doi: 10.1007/978-1-4614-
9022-7_14
to authorized users.
J. H. Marks , MD, FACS, FASCRS (*)
Division of Colorectal Surgery, Department of Surgery ,
Main Line Health Systems, Lankenau Medical Center ,
Wynnewood , PA , USA
Division of Colorectal Surgery , Lankenau Medical Center ,
100 E Lancaster Ave, MOBW Suite 330 ,
Wynnewood , PA 19096 , USA
e-mail: marksj@mlhs.org
H. Reynolds , MD, FACS, FASCRS
Colon and Rectal Cancer Surgery ,
Case Western Reserve University,
University Hospitals Case Medical Center , Cleveland , OH , USA
e-mail: harry.reynolds@uhhospitals.org
) contains supplementary material, which is available
1 4
Introduction
Key Concept: The emergence of local therapies for rectal
cancer is a paradigm similar to breast cancer treatment.
The search for the ideal treatment of rectal cancer continues to evolve. With advances in our understanding of the disease, the treatment algorithms available have become ever
more complex. A multidisciplinary team approach is now the
standard of care, but surgeons treating rectal cancer are
responsible for understanding and directing all aspects of
these ever-evolving multidisciplinary care paths. Staging
modalities, though not yet perfected, continue to advance,
allowing us to more carefully tailor care to our patients.
Neoadjuvant chemoradiation is selectively used and with
much success. Surgical options continue to expand as well,
ranging from local resection techniques to total mesorectal
excision, utilizing open, laparoscopic, and, now, robotic
approaches. Local resection options include standard transanal excision (TAE), transanal minimally invasive techniques
(TAMIS), and transanal endoscopic microsurgery (TEM).
An ideal treatment strategy would be curative while preserving sphincter function with minimal perioperative morbidity and mortality. Local excision techniques seem ideal in
that they are sphincter preserving and can be accomplished
with minimal morbidity and mortality when skillfully performed. Local excision of rectal cancer offers the promise of
truly the ultimate application of minimally invasive surgery.
Addressing a cancer transanally is really the longest standing
application of true natural orifi ce surgery, or “NOTES,” which
has recently been spoken of so greatly. The question that
arises when you talk about a local excision for rectal cancer
is: is this a good idea or really just a leap of faith by the clinicians hoping to avoid the trauma and the diffi culty of a radical
resection for a diffi cult rectal cancer? The trends in oncologic
surgery have been evermore focused upon not only curing the
cancer but also doing so with the highest quality of life. Using
breast cancer as a comparator, we have really seen a very
similar evolution in rectal cancer. Breast cancer has seen
the transition of the standard treatment from the radical
S.R. Steele et al. (eds.), Complexities in Colorectal Surgery,
DOI 10.1007/978-1-4614-9022-7_14, © Springer Science+Business Media New York 2014
219
220
J.H. Marks and H. Reynolds
mastectomy in 1960s and 1970s, to modifi ed radical mastectomy, to lumpectomy and axillary dissection with external
beam radiation, and now to lumpectomy and sentinel node
resection with external radiation. Similarly, rectal cancer’s
evolution has progressed markedly over the past 100 years.
Miles fi rst described the abdominoperineal resection in 1907
[
1 ]. This has remained the bulwark of treatment for rectal
cancer, even up to the present day. However, in the mid- to
late 1970s, sphincter preservation was fi rst being described
for lower rectal cancers, even after radiation therapy [ 2 ].
Having moved from postoperative radiation therapy to preoperative radiation therapy in the treatment of rectal cancer,
there has been noted a regression of tumor size. In turn, this
has led to a question of local excision after neoadjuvant therapy. Additionally, for early rectal cancer, there is a question if
a local excision alone is a suffi cient treatment of the cancer.
The issue with rectal cancer is, of course, that not all rectal cancers are the same. There is no cookie cutter approach
to the treatment of this disease, which not only threatens the
patient’s life but also impacts so dramatically their quality of
life. The signifi cant risks of bladder and sexual dysfunction,
need for a permanent colostomy, issues regarding body
image, and complications of major surgery and stomas
require us to reassess our approach to rectal cancer.
In looking at rectal cancer, it is obvious that not all of
them are created equal. Treatment options will vary markedly depending on the level of the cancer in the rectum,
whether lymph nodes are involved and clearly what the T
stage of the cancer is. In fact, we always joke that Sigmund
Freud would state that surgeons dealing with low rectal cancers are highly confl icted, even schizophrenic, in their
approach to the T1 rectal cancer. What that means, and how
we approach that, represents really the basis of this chapter.
Our goal is to review the indications for, and contraindications to, local excision; discuss technical pearls for success;
and review outcomes reported with traditional TAE, TAMIS,
and TEM.
Patient Selection
Key Concept: Proper patient evaluation, staging, and selection of patients for a transanal approach are the fi rst, and
likely the most crucial, aspects to optimize outcomes.
Beware—not all T1 lesions are the same!
We are going to initially focus on the following areas of
confl ict for T1 cancers:
1. Radical total mesorectal excision (TME) surgery: when is
it needed? When is an APR needed?
2. When is a local excision adequate? When is it not? What
constitutes an adequate local excision, and who is going
to benefi t from TEM/TEO or TAMIS surgery?
3. The role of radiation or chemoradiation in the T1 rectal
cancer: when is that applied? What is the rationale for it?
While the approach of transanal excision has traditionally
been limited to cancers in the distal rectum, with the advent of
TEM [
3 ] and TAMIS [ 4 ], the ability to operate endoluminally
has applied these approaches to the entirety of the rectum. The
initial evaluation of the rectal lesion is critical, as there are
marked differences between various T1 cancers. Oftentimes,
we refer to this in our unit as the difference between a polyp
with a small focus of cancer and a polypoid cancer, based on
the amount of involvement of the cancer in the submucosa. The
central aspect of the preoperative evaluation is that it is thorough. As with any colorectal cancer patient, a CT of the chest,
abdomen, and pelvis is performed for staging, and a baseline
carcinoembryonic antigen is obtained. A thorough assessment
of the patient’s comorbidities and fi tness for surgery is undertaken because a key factor in surgical decision-making is
whether the patient will tolerate a formal proctectomy.
An essential tool for evaluation is a careful digital rectal
examination. Status of the sphincter tone (both at rest and
with squeeze), position of the mass, and level in the rectum—
both distal and cephalad—are of central importance. The size
of the tumor, whether or not it is ulcerated, and the clinical
stage of the disease are all important variables that must be
noted and recorded. In addition, fi xation, adjacent organ
involvement, and relationship to the peritoneal refl ection are
considered and documented. Tumors which are fi xed and
deeply ulcerated or involve adjacent organs are not suited for
local excision. Likewise, tumors greater than 3–4 cm in diameter can be diffi cult to locally excise, as the defects created
are typically greater than half circumferential and can be
challenging to close. Anterior, posterior, or lateral location of
the tumor is particularly important to ascertain as patient
positioning at surgery is determined by tumor location.
Anteriorly based tumors are approached in a prone jackknife
position, and posterior tumors are typically approached from
lithotomy. Anteriorly based tumors above the middle rectal
valve must be approached with caution as they may lie above
the peritoneal refl ection. It is also important to recognize that
many female patients may have deep cul-de-sacs that may
cause the intraperitoneal location to be more caudal than
expected. This can result in a challenging closure if the peritoneal cavity is breeched but oftentimes is better dealt with if
you are not surprised by this occurrence. Ideal tumors for
local excision are exophytic or pedunculated, small, mobile,
in the distal rectum, and posteriorly located. Relative contraindications to local excision include poorly differentiated histology or the presence of lymphovascular invasion [ 5 ].
Staging the Lesion
Key Concept: Know the limitations of your institution, as
both MRI and ERUS have a component of “user” variability
to accurate staging. Your digital examination can often give
you the most reliable and helpful information.