Reference Section
a report by
Iain G M Cleator, MB, ChB, FRCS(c), FRCS(E), FACS, FRCS
and Maria M Cleator, MD
Professor Emeritus of Surgery, University of Columbia, and Research Associate,The Cleator Clinic
What are Hemorrhoids?
There are three cushions of tissue at the lower end of the
rectum just above the dentate line and about 3cm from
the anal verge.They are in the left lateral, right posterior
and right anterior positions, and consist of vascular
complexes intermingled with muscle fibers from the
internal sphincter. Normally, these slip out a little at
defecation and retract after providing a cushion or
protection for the deeper layers of the anus, and help
maintain continence. These can probably discriminate
between solid,liquid,and gas in the lower rectum and are
likely important in permitting the passage of flatus
without soiling. In some people, these cushions prolapse
more and more, the attachment to the internal sphincter
becomes poor, and internal hemorrhoids are formed.


There are a lot of possible causes for this,but the concept
that has found the greatest favor is that described by
Burkitt1 ý low intake of soluble fiber and water. Internal
hemorrhoids are in four degrees. In the first degree the
hemorrhoids bleed, second degree they bleed and
prolapse but reduce spontaneously, third-degree
hemorrhoids bleed and prolapse and have to be replaced
manually, and fourth-degree bleed and incarcerate but
cannot be reduced. Pain is not usually found in internal
hemorrhoids unless they are fourth degree.1
Many patients with internal hemorrhoids form engorged
external hemorrhoidal veins under the skin around the
anus as time progresses, and this causes the skin to stretch
and skin tags are formed that interfere with hygiene and
are uncomfortable. Many patients with internal
hemorrhoids also have an anal fissure, usually posteriorly,
which can co-exist with the hemorrhoids and in time
causes spasm of the internal sphincter resulting in further
tearing and ulceration and a lot of pain.


The Device
This is a plastic plunger suction device resembling a
syringe, which is applied to each hemorrhoid in turn,
1cm above the dentate line, suction induced to cause the
bulk of the hemorrhoid cushion to enter the nozzle, and
then release the band to strangulate the hemorrhoid.


Only one band is used to facilitate later adjustment.This
can be performed under direct visualization with a
specially designed proctoscope (see Figure 1), or using a
ýblindý technique where the device is inserted to a mark
through the anus and directed to one of the hemorrhoid
cushions, which is then banded (see Figure 2).


At the conclusion of this part of the procedure, a gloved
finger is introduced into the anus and the band moved
with the finger if too much tissue has been grasped, or
rolled upwards if it is too low (see Figure 3).The band can
rarely be removed completely by rolling it off with the
examining finger. In almost all cases, the band is rolled a
little to adjust it and make sure that only mucosa,and not
the muscle coat, is captured by the band.This is judged
by feeling a sliding of the banded mucosa over the deeper
muscle. If there is significant discomfort the band is
always rolled upwards or (rarely) re-applied after rolling
off the first band. Usually, only one band is applied at
each visit, and the patient is told there will be a feeling of
fullness for a day or so but no pain.


The Patients
This is a prospective study of the treatment of
hemorrhoids in all patients presenting to the clinic by
referral from their family doctor or specialist between
November 2002 and December 2004. All of the
patients had a history and exam including rigid
disposable sigmoidoscope and digital rectal
examination. At the end of their treatment course, a
stool occult blood test was performed. Colonoscopy is
performed by another specialist in a hospital setting on
those patients with diagnosed cancer or polyps or
inflammatory bowel disease on exam, or for those
with signs of blood loss from higher up. Colonoscopy
performed as a routine, already on a follow-up
program, or for strong family history is not included
in the statistics.


The Clinic Set Up
This is a purpose-built clinic specializing in hemorrhoids
centrally located on Broadway in Vancouver.The clinic is
1,200 square feet with secretarial station and small
waiting area, doctorýs office and four examining rooms
with examining table and counters, and storage and sinks
in every room.


Banding Hemorrhoids Using the OýRegan Disposable Bander
Iain G M Cleator, MB, ChB, FRCS(c),
FRCS(E), FACS, FRCS, is Professor
Emeritus of Surgery at University of
British Columbia (UBC). He operates
the Cleator Clinic in Vancouver,
which specializes in the treatment
of hemorrhoids. He is also Block
Chair of the Gastro-Intestinal
section of the Problem Oriented
Learning Program at UBC for the
next three years. Professor Cleator
founded the Mr and Mrs Woodward
GI Clinic at St Paulýs hospital,
where he held many positions over
the years including head of the GI
Clinic and Head of Service A. He
carried out more than 13,000
colonoscopies over this time and
specialised in GI and bariatric
surgery. He retired from hospital
work in January 2003 and opened
the Cleator Clinic at that time
which currently serves many of the
patients with this problem. He is a
past president of the Canadian
Association of Gastroenterology, past
president of the Vancouver Medical
Association and was a board
member of the BCMA for ten years.


He has published more than 100
papers, chapters or articles. He has
also published papers and given
lectures on Time. His academic
interests include early detection of
colorectal cancer. Professor Cleator
trained in Edinburgh in general
surgery and graduated in 1962,
taking up a position as an
academic surgeon at UBC in 1972.


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All equipment is disposable ý gowns,sheets,proctoscopes,
sigmoidoscopes, banders.There are telephones in every
room and the computer system is fully up-to-speed
(Macintosh) with links between secretary and doctor and
reports going out at the end of each day on the patients.


The patients come by referral. The counters and
examining couches are wiped down with bactericidal
wipes between patients. The times worked by the
physician are five half days per week, and they are on call
after hours.The office nurse is friendly and multilingual.


The clinic is bright and cheerful and new and has
flowers at all times.The patient fills in a short history
form of previous illnesses and infections, and a history
is taken and exam including proctosigmoidoscopy
performed.As a rule, no more than one band is applied
at a time, and the first band is applied at this visit and
then weekly thereafter. If there is a concomitant fissure,
Nitroglycerin ointment is supplied. If there is pruritus,
Canesten with hydrocortisone cream are supplied. If
the fissure has a lot of spasm, or there are fourth-degree
hemorrhoids, banding is postponed for three weeks.


Sitz baths are advised for fourth-degree hemorrhoids
or severe fissures.


All patients are given written instructions in their own
language on their condition and asked to take soluble
fiber (two tablespoons or bran or equivalent of
Metamucil or other) and seven to eight glasses of water
daily.They are also told not to spend more than two
minutes on the toilet for a bowel movement and non-
fiber laxatives or Codeine preparations are discouraged.


If they are traveling soon, they are advised to pack
whole-wheat sandwiches to eat and to take two liters of
water to supplement the supplies on the plane.


After the banding is completed, a stool occult blood test
is performed (three windows) using the guaiacum test.


If this is positive, colonoscopy is recommended. If there
are other indications, colonoscopy is recommended.We
plan to change the FOBT to the two-tier test soon,
which incorporates a second immunochemical test
specific for the presence of human blood.Many patients
have had or are about to have colonoscopy referred
already by their family doctor. We do not perform
colonoscopy in the clinic and refer to other specialists
who carry this out in local hospital clinics. Occasionally
antibiotics are indicated prophylactically (heart valve
problems) or therapeutically (very inflamed fissure).


The number of bandings per individual is variable. A
few respond to one band or even diet advice alone,1
while others have more than three bandings.The reason
for the extra bands is that some patients had such huge
hemorrhoids that the band did not include the whole
hemorrhoid, and other areas needed to be banded later.


The total number of bandings was 5,424.


The Results
There are 1,852 patients in the study; 926 are female
and 926 are male.The average age is 49.1 years.There
were 5,424 bandings performed in the patients.


Results are summarized in Table 1.


Banding Hemorrhoids Using the OýRegan Disposable Bander
B USINESS BRIEFING: US GASTROENTEROLOGY REVIEW 2005
Figure 1:This Illustrates in Diagrammatic Form the
Process of Applying the Band on the Hemorrhoid using
the Proctoscope (Usual Technique)
Figure 2:The ýBlindýTechnique without using the
Proctoscope.The Anus is Shown Dilated to
Demonstrate this more Clearly
Figure 3:The Procedure for Rolling the Band when
there is Discomfort or the Band Catches the
Muscle Coat
2
Although there were only 53 first-degree hemorrhoids,
there were 13 cancers or large polyps in this group.


Fifty-seven patients had a first-degree relative with
colorectal cancer, but none had a large polyp or
colorectal cancer. Nine had a history of previous
colorectal cancer. Five patients had unexplained weight
loss, and two of these had colorectal cancer. Twenty-
four patients had a pre-existing infectious disease ý
HIV, hepatitis A, B, C, or genital herpes or warts, or a
combination.Two of the three cases of anal cancer were
in patients with HIV.


Of the patients involved, 155 had a colonoscopy
generated directly from findings on rectal, procto-
sigmoidoscopy, or fecal occult blood test (FOBT)
after treating the hemorrhoids, from bleeding seen
coming from higher up, or no source found on
proctosigmoidoscopy.There are 30 patients found to
have inflammatory bowel disease, mostly ulcerative
colitis, but some post-irradiation colitis. Forty-seven
patients had a large polyp (10), rectal cancer (26),
colon cancer (eight), or anal cancer (three) found.


There are still 15 patients awaiting colonoscopy, so
these figures may increase. One patient had an upper
gastrointestinal (GI) cancer found. Thirty-one
patients had some degree of incontinence of stool,
and all were cured or improved after banding. Eighty-
eight patients developed a recurrence, treated
successfully with banding. Two patients went to
surgery for their hemorrhoids. The complications
were as follows (see Table 1 and 2):
ý Eight post-banding bleeds ý these were dramatic for
the patient but usually settled with telling the patient
to lie down and bringing them into the office for
evaluation later, finding there was no site for the
bleed, or a fissure.


ý Two patients were hospitalized (there was no sepsis).


ý Three patients had severe pain after banding,
which was treated with lidocaineýprilocaine
(EMLA) cream.


ý Five patients had thrombosis of a hemorrhoid after
banding, which resolved with time and sitz baths.


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Reference Section
Table 2: Number and Percentage of Complications of the 5,422 Banding Procedures
Number Percentage of 5,424 Bandings
Post-band bleed 8 0.15
Post-band thrombosis 5 0.09
Post-band pain 3 0.06
Post-band other 0 0.00
Table 1: Important Findings in the 1,851 Patients in this Report
Number of Patients Percentage of Patients
Total 1,852
First-degree hemorrhoids 53 2.9
Second-degree hemorrhoids 1,527 82.5
Third-degree hemorrhoids 143 7.7
Fourth-degree hemorrhoids 129 7.0
Family history of colon cancer ý first-degree relative 57 3.0
Past history of colorectal cancer 9 0.5
Unexplained weight loss 5 0.3
AIDS, hepatitis A, B, C, genital herpes, warts, combination 24 1.3
Bleeding disorder 9 0.5
Colonoscopies indicated 155 8.4
Colorectal cancer or large polyp or Ca anus found 47 2.3
IBD found 30 1.6
Incontinence 31 1.7
Hemorrhoids recurred 88 4.8
Bleeding disorder 9 0.5
# of bandings 5,424 292
Overall complications 16 0.9
Post-band bleed 8 0.4
Post-band thrombosis 5 0.3
Post-band pain 3 0.2
Post-band other 0 0.0
3
There were no other complications.There were nine
patients with coagulation problems, usually because
they were taking coumadin for medical conditions.Two
stopped their coumadin temporarily while being
banded, but all were treated by banding.There was a
minor bleed in one patient, which was treated in the
office with silver nitrate.


Discussion
There is general agreement in the literature that rubber
banding of hemorrhoids is safe and effective1,3 and that
surgery should be reserved for those who have large
third- or fourth-degree hemorrhoids or ýmixedý
hemorrhoids not responding to elastic ligation or those
on anticoagulants.


The complication rates for banding vary from series to
series but the common themes of all the follow-ups are
bleeding, pain, thrombosis, sepsis, urinary retention, and
anal stenosis.


Late bleeding is estimated at 1% by Corman.3 Our figure
of 0.15% is much less.We attribute this to two factors ý
less tissue trauma from the gentle suction, rather than the
grasping forceps generally used,and the method of easing
up the band to make sure the underlying muscle is not
entrapped, resulting in low-level sepsis. Significant pain is
estimated at 4% by Bartizal and Slosberg3 in their 670
patients, and Lee found 4.5% for single banding and 29%
for multiple bands4 ý our figure is 0.06%. Schwartz
claims, and we believe, that severe pain is caused when
the band is positioned too low on the anoderm where
there is a rich supply of pain fibers.2 This is easy to do
with large hemorrhoids. However, this is avoided in our
technique of using one band rather than two and rolling
it upwards if there is pain immediately. It is our
experience that if there is pain from a band, it usually
comes on in three minutes, and seldom improves
without changing the position of the band or removing
it (rare ý rolling it off).Thrombosis is estimated at 3%,3
and the figure for our patients is 0.09%.We attribute this
lower figure to band positioning and emphasis on fiber
and water in the diet. Urinary retention is as common as
10% to 50% after surgical hemorrhoidectomy, and 1% is
the figure quoted by Schwartz as acceptable after
banding, although he comments that 10% to 20% have
been seen after multiple ligations.2 We had none in our
group and attribute this to avoiding entrapping the
muscle layer with the rubber band by easing it up after
applying the band and to performing single ligations.


Stenosis of the anus has occurred in patients following
banding, more commonly after simultaneous multiple
banding.5 We had none in our series.


Sepsis is rare and to be feared. It is thought that
inadvertent banding and later necrosis of the muscle
layer is a possible cause, and we concur with this and
avoid this with our technique.We are still constantly
aware of this dangerous and life-threatening
condition, and on the look-out for a patient with
increasing pain, fever, and difficulty with micturition.


The absence of this complication so far in our series
has not led to complacency.


When the histories of our patients were taken, it was
evident that every modality of hemorrhoid treatment
had been performed on most of the patients at one
time or another prior to banding, and none was
successful in the long-term. Our recurrence rate of 88
or 4.8% is less than the 12% reported by others,6 but
we expect ours to increase with longer follow-up. It
was clear, from talking to the patients who returned,
that most had discontinued the advice on diet and
toilet quickly after completion of their banding.This
encourages the belief that a regular follow-up
program, perhaps yearly, is required.


The high prevalence of colorectal cancer and anal
cancer (six times that expected) is unexplained.An old
idea is that a rectal lesion would increase the pressure
in the superior hemorrhoidal veins and make them
bleed. Factors related to cancer were first-degree-only
hemorrhoids, absence of fissure, and unexplained
weight loss.The factor related to anal cancer was HIV
infection (present in two of the three cases found).


There was also a significant number of patients with
inflammatory bowel disease found and treated in this
group.This association is well described.The association
with post-irradiation colitis is noteworthy.


Because this has been such a safe technique, nine
patients had banding who had clotting disorders. Most
were very poor candidates for operation because of
their general health.There was only one minor bleed in
this group, and that was from a fissure. Perhaps in
carefully selected patients this type of banding may
prove useful in the future.


A surprising finding was the cure or improvement of
fecal incontinence or soiling in the 31 who had this
problem.This seems a simple and non-invasive step for
these patients and may well work by calibrating or
narrowing the outlet.There was usually benefit after the
second band.


Infection Considerations
The Medsurge ligator is disposable and can be used by
one person without an assistant.The risk of transfer of
infection through instruments is a constant anxiety to
the surgeon. Some patients with hemorrhoids do
harbor some serious infections ý 24 of our patients
Banding Hemorrhoids Using the OýRegan Disposable Bander
B USINESS BRIEFING: US GASTROENTEROLOGY REVIEW 2005
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admitted to HIV or Hepatitis A, B, or C, or genital
herpes or warts, or a combination. There are many
other harmful bacteria in stool in all patients. In surgery
we are using disposables in syringes, forceps, and
catheters and many other items, but have not yet made
the switch to a disposable ligator. Now is the time to do
this and avoid the costs and inconvenience, and the risk
of cleaning and sterilizing metal ligators.


Conclusion
The Medsurge ligator represents an important advance in
the banding of hemorrhoids. It should be the first choice
for the treatment of internal hemorrhoids because of
patient acceptance and reliable results and infrequent
complications.The fact that it is a disposable avoids many
of the potential problems of the older instruments. a73
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Reference Section
References
1. Burkitt D P, Graham-Stewart C W, ýHaemorrhoidsýpostulated pathogenesis and proposed preventioný, Postgrad. Med. J.


51(599) (1975 Sep), pp. 631ý636.


2. Schwartz S I, ýPrinciples of surgeryý, 6th Edition, McGraw-Hill Inc, New York, St Louis, San Francisco et al., (1994),
pp.1,222ý1,229.


3. Corman M L,ýColon and rectal surgeryý, 5th edition, Lippincott,Williams & Wilkins. Philadelphia (2005), pp. 178ý248.


3. Bartizal J, Slosberg J,ýAn alternative to hemorrhoidectomyý, Arch. Surg. 112 (1977), pp. 534ý536.


4. Lee H H, Spencer R J, Jr Beart R W,ýMultiple hemorrhoidal bandings in a single sessioný, Dis. Colon Rectum 37 (1994),
pp. 37ý41.


5. Lau W Y, Chow H P, Poon G P, et al.,ýRubber band ligation of three primary hemorrhoids in a single sessioný, Dis. Colon
Rectum 25 (1982), pp. 336ý339.


6. Steinberg D M, Liegois H,Alexander-Williams J,ýLong term review of the results of rubber band ligation of haemorrhoidsý, Br.


J. Sur. 62 (2) (1975), pp. 144ý146.


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