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Rubber band ligation versus endoscopic injection sclerotherapy for

symptomatic second-degree hemorrhoids: A prospective randomised trial

Article in Chirurgia · October 2013

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CHIRURGIA 2013;26:341-3

Rubber band ligation versus endoscopic injection

sclerotherapy for symptomatic second-degree hemorrhoids:
a prospective randomised trial
G. CESTARO, M. DE ROSA, F. MOSELLA, B. AMATO, M. GENTILE

® A
Aim. Symptomatic internal hemorrhoids are a very common Department of General Surgery

T C
finding used to be treated with conservative technique. Among “Federico II” University of Naples, Naples, Italy
these approaches, rubber band ligation (RBL) and endoscopic
injective sclerotherapy (EIS) can be considered the best con-

H DI
servative outpatient treatments. The aim of this study was to
compare RBL to EIS regarding effectiveness and complications
in the treatment of symptomatic internal hemorrhoids.
Methods. Seventy-two adult patients with symptomatic inter- grade internal hemorrhoids. Both are quite easy to apply

IG E
nal hemorrhoids were randomized into two equal groups; the
first treated with RBL and the second with EIS. All groups were
comparable for age, sex, pre-operative symptoms and working ac-
and readly available procedures.3 Sclerotherapy determinate
a submucosal fibrosis around the vessels of haemorrhoidal
plexus, while in ligation a band is applied by a dedicated
R M
tivities. Pre and post-procedure data were recorded and analyzed.
Results. Bleeding was observed in 11% (4/36) of RBL group and tool to the base of the piles causing an ischemic necrosis of
8 % (3/36) of EIS group. Significative pain was in 11% (4/36) of hemorrhoids and enhancing tissue fibrosis.4
RBL group and 14% (5/36) of EIS group. Recurrence rate was The aim of this study was to compare endoscopic in-
14% (5/36) in the RBL group and 17% (6/36) in the EIS group. jection sclerotherapy to rubber band ligation regarding ef-
P A

Moreover, there was one case of prostatitis in EIS group. fectiveness and complications in the treatment of second-
Conclusion. Both RBL and EIS were effective in the treatment degree internal hemorrhoids.
O V

of symptomatic internal hemorrhoids. There were no statisti-

cally significative differences between studied groups regarding
effectiveness, recurrence disease, bleeding and pain.
Materials and methods
C ER

Key words: Ligation - Endoscopy - Sclerotherapy.

From 1 January 2010 to 31 December 2012 seventy–two
Y

consecutive adult patients with symptomatic second-de-

I nternal hemorrhoids are to very common disease and,
despite the improvement of surgical therapy, many pa-
gree hemorrhoids according to Nivatvongs’ classification
were randomly divided into two equal groups. The first was
IN

tients are still reluctant to operate and prefer undergo a con-
servative treatment. The most important factors influencing
the choice are fear for postoperative pain and the wish to
avoid complications and hospitalization. Following the Ni-
M
treated with RBL using Sapi-Med suction hemorrhoids li-
gator and the second was treated with IS using Lauromac-
rogol 400 (Atossisclerol 3%).
Exclusion criteria were: external hemorrhoids, internal

vatvongs’ classification of hemorrhoids,1 surgical approach
is indicated for III-IV degree heamorrhoids, while sympto-
matic internal piles can be managed by office procedures.
An intermediate role plays Doppler guided dearterialization,
a novel technique whose promising results are reported even
for 2nd grade hemorrhoids. However this technique requires
anesthetic block and some kind of hospital stay, so it cannot
be considered a conservative treatment.2
or other proprietary information of the Publisher.
hemorrhoids infected or containing thrombi, hemorrhoids
with evidence of inflammation, ulceration and gangrene,
tags, fistulas, tumors and anal fissure.
All patients were evaluated preoperatively with a com-
plete proctological examination including past proctologic
history, continence evaluation (Wexner continence score)
and anoscopy: a colonoscopy was performed in those aging

over 50 years to rule out colonic cancer.

To date there are a lot of different conservative treatments
for symptomatic hemorrhoids. Among these, rubber band
ligation (RBL) and injection sclerotherapy (IS) are thought
to be the best candidates to replace surgical therapy for low
Corresponding author: M. Gentile MD, Department of Gen-
eral Surgery, “Federico II” University of Naples, Naples, Italy.
E-mail: magentil@unina.it
Patients enrolled for the study were divided into two
groups by using a computer-generated list for randomi-
zation: the code enclosed in a numbered envelope corre-
sponding to one of the two techniques was shown at the
beginning of the operation to the surgeon.
After a complete and comprehensive explanation from
a member of the surgical team, an informed consent was
subscribed by patients.

Vol. 26 - No. 5 CHIRURGIA 341

not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo,
means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is
This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies
(either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other

CESTARO Rubber band ligation versus endoscopic injection sclerotherapy

All procedures involved three different surgeons (MG, Table I.—Patients characteristics in the two groups.
MD, GC) and were performed as office treatment. RBL (36 pts) IS (36 pts) p value
Patients were assessed 1, 2, 4 and 12 weeks after pro- Age (years) (range) 36.7 (18-60) 37.2 (18-60) NS
cedure. Male/Female ratio 1.3 (18-60) 1.4 (18-60) NS
At follow-up visits, they were asked about the occur- Wexner Continence score 0 (0-2) 0 (0-2) NS
rence of symptoms (bleeding, pain, itching) and adverse (range)
or acute events, and an accurate proctoscopic examination Bleeding (pts) (%) 32 (88.9%) 34 (94.4%) P=0.6737
was performed, taking into account the presence of postop- Pain (pts) (%) 35 (97.2%) 32 (88.8%) P=0.3570
erative prolapse, alteration of sphincter tone, and residual Itching (pts) (%) 29 (80.5%) 30 (83.3%) P=1.0000
haemorrhoidal piles, with classification of the grade of
hemorrhoids in the different quadrants of the anal canal.
Resolution of symptoms was evaluated on the basis of both
the patient interview and the physical examination. Table II.—Results and overall complications in the two groups.
In addition, at each follow-up visit, patients were asked RBL (36 pts) IS (36 pts) P value
to objectively assess their postoperative pain by using a Resolutions of symptoms at 12 28 (77.8) 25 (69.4) P=0.5936
10-cm VAS scale, self-administered and supervised by a weeks follow-up n (%)

® A
blinded and independent observer (surgical resident). VAS Bleeding 04 (11%) 03 (8%) P=1.0000
value of at least seven was associated to a significative Acute urinary retention 01 00 P=1.0000
post-operative pain.

T C
Thrombosis 00 01 P=1.0000
Tenesmus 01 00 P=1.0000
Operative technique

H DI
Recurrence 05 06 P=1.0000
As preoperative protocol both groups of patients were Prostatitis 00 01 P=1.0000
cleaned by a saline enema on the evening before the opera- Pain (more than 7 at VAS-scale) 05 04 P=1.0000
tion. No sedation was required on a routine basis with these Overall complication rate N. (%) 05 (33.3) 05 (28) P=1.0000

IG E
procedures, and patients were discharged after the opera-
tion (day surgery). No bowel preparation was required.
R M
The operation was performed in Sims position in both RBL group were free from hemorrhoidal symptoms, com-
groups. pared with 25 (69.4%) patients in the EIS group (P=0.5936)
In the RBL group the procedure was carried out by using (Table II). In both groups, when treatment failed, patients
an operative anoscope and applying with a disposable suc- reported no improvement of preoperative symptoms (bleed-
tion haemorrhoidal ligator two rubber bands to the level of
P A

ing, discomfort, mucous discharge).

the vascular pedicle. The procedure was repeated for each Three parameters were considered: bleeding, pain and
quadrant. When the rings were in place, the anoscope was
O V

recurrence.
withdrawn. Bleeding was observed in 11% (4/36) of RBL group and
In EIS group the procedure was performed by using an 8 % (3/36) of IS group.
C ER

anoscope to inspect the entire anal region and evaluate the Pain, evaluated by a self-administered VAS (Visual
position of hemorrhoids. We usually adoperate a syringe Analogic Scale) in cm (0-10), was significant in 4 patients
Y

with a long angle needle (Gabriel needle), which is intro-
duced through the mucous membrane into the center of
the mass of veins. Because the possibility that the solu-
IN
(11%) of RBL group and 5 (14%) of EIS group. Recur-
rence rate was 14 % (5/36) in the RBL group and 17%
(6/36) in the EIS group. We registered one case of pros-

tion might be injected into the circulation, we are used to

withdraw the plummer of the syringe to see if blood ap- tatitis and haemorrhoidal thrombosis in EIS group, while
pears. After the needle is in position the solution is slowly in the RLP group we observed one case of acute urinary
injected submucosally into each pile site 5. retention and one case of tenesmus (Table II).
M

Statistical analysis Discussion

Data were expressed as median values and values of less
than .05 were considered statistically significant. Mann-
Whitney U-test was used for postoperative pain between
RBL and IES group. Fisher exact test was used for the in-
cidence of postoperative complications.
or other proprietary information of the Publisher.
Hemorrhoids are one of the most common problems af-
fecting in various forms almost 50% of people over fifty
years old.
The present randomized trial compares the RBL tech-
nique with EIS, two of the most common and simple office

treatments for symptomatic internal hemorrhoids. RBL is

Results
The two studied groups were comparable for age (mean
age: 36.7 [18–60] for RBL, 37.2 [18–60] for IS patients;
gender (male/female ratio 1.3 for RBL and 1.4 for IS, not
statistically significant) and symptoms (Table I).
At the 12 weeks follow-up, 28 patients (77.8%) in the
considered to be an effective conservative treatment, but
many patients have discomfort for several days after pro-
cedure.6 EIS is similarly effective, but it is not free from
occasionally serious complications such as retroperitoneal
sepsis, perianal abscess, necrotizing fasciitis of perineal re-
gion 7, urological severe damages.8
A meta-analysis of 23 randomized controlled studies

342 CHIRURGIA OTTOBRE 2013

not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo,
means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is
This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies
(either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other
Rubber band ligation versus endoscopic injection sclerotherapy
comparing proctoscopic, endoscopic and surgical therapies
for internal hemorrhoids reported that sclerotherapy was
less effective than rubber band ligation or surgery.9
Another study compared sclerotherapy, rubber band li-
gation and infrared coagulation reported that rubber band
ligation is more effective than the other treatment modali-
ties.10
This study showed no significant difference between the
two techniques regarding effectiveness, bleeding, pain and
overall complications.
Regarding resolution of symptoms, we observed a simi-
lar overall satisfaction in both groups of patients (77.8%
for RBL versus 69.4% for EIS), with not statistically sig-
nificant difference.
Bleeding was observed in 4 patients during RBL and in
3 patients during EIS. Surgical hemostasis was necessary
® A
in 1 of the 3 patients with bleeding during EIS.
Postoperative pain scores on the VAS scale were slightly
T C
higher after RBL than after EIS during the first 48 hours. This
result might be partially attributed to the multiple banding (in
3 positions) used by surgeons in this study, but early post-
H DI
operative pain is also reported after RBL in other series.11, 12
The presence of “foreign bodies” above the dentate line
may be responsible for the tenesmus and urinary retention
reported by two different patients after RBL. Anyway, at 1
IG E
week follow-up control, no statistically significant differ-
ences between the two groups were reported in pain scores.
R M
Results of this study indicate that the analyzed non-sur-
gical methods are encourangingly effective in the treatment
of low grade internal hemorrhoids and they are associated
to any severe complication. There were no statistically sig-
P A
nificative differences between studied groups regarding ef-
fectiveness, recurrence, bleeding and pain.
O V
A limitation of the present study can be identified in the
small size of the sample and the limited follow-up: thus,
the benefits of these approaches need to be furtherly evalu-
C ER
ated in larger series for longer period, even because both
techniques can be repeated without an increased morbid-
Y
ity rate 13, avoiding the recourse to the so feared surgical
intervention.
IN
Conclusions
Results of this study indicate that the Both RBL and EIS
M
are effective in the treatment of second–degree internal
hemorrhoids. There were no statistically significative dif-
ferences between studied groups regarding effectiveness,
recurrence, bleeding and pain.
Riassunto
or other proprietary information of the Publisher.
Confronto tra legatura elastica e scleroterapia per le emorroidi sin-
tomatiche di secondo grado: studio prospettico randomizzato
Obiettivi. Le emorroidi interne sintomatiche costituiscono una
patologia frequente e sono di solito trattate con metodiche conser-
vative. Tra questi approcci, la legatura elastica (RBL) e l’iniezione
Vol. 26 - No. 5 CHIRURGIA
CESTARO
di sostanza sclerosante (EIS) possono essere considerate i migliori
trattamenti ambulatoriali. Scopo di questo studio è stato confron-
tare la legatura elastica con la scleroterapia in termini di efficacia
e complicanze per quanto concerne il trattamento delle emorroidi
interne sintomatiche.
Metodi. Settantadue pazienti adulti affetti da emorroidi interne
sintomatiche sono stati distribuiti casualmente in due gruppi uguali;
il primo trattato con legature elastiche, il secondo con iniezione di
sostanza sclerosante (scleroterapia). Ambedue i gruppi erano com-
parabili per età, sesso, sintomi preoperatori ed attività lavorativa. I
dati pre e postprocedure sono stati riportati ed analizzati.
Risultati. Il sanguinamento è stato riportato nell’11% (4/36) del
gruppo RBL e nell’8% (3/36) dei pazienti del gruppo EIS. Dolore
significativo è stato rilevato nell’11% (4/36) del gruppo RBL e nel
14% (5/36) del gruppo EIS. Il tasso di recidiva è stato osservato
nel 14% (5/36) del gruppo RBL e nel 17% (6/36) del gruppo EIS.
Inoltre c’è stato un caso di prostatite nel gruppo EIS.
Conclusioni. Ambedue le metodiche, legatura elastica emorroi-
daria e scleroterapia, sono efficaci nel trattamento delle emorroidi
interne sintomatiche. Non c’è nessuna differenza statisticamente
significativa tra i due gruppi studiati per quanto riguarda efficacia,
recidiva di malattia, sanguinamento e dolore.
Parole chiave: Legatura - Endoscopia - Scleroterapia.
References
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Received on October 16, 2012.
Accepted for publication on November 29, 2012.
343
 This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies
(either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other
means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is
not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo,
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344
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CHIRURGIA
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OTTOBRE 2013
Rubber band ligation versus endoscopic injection sclerotherapy