PIIS1051044323001112
PIIS1051044323001112
PIIS1051044323001112
ABSTRACT
Purpose: To compare short-term and medium-term results of superior rectal artery embolization versus surgical hemor-
rhoidectomy in the treatment of patients with hemorrhoidal disease.
Material and Methods: This study was a prospective randomized clinical trial following 33 patients with symptomatic
hemorrhoidal disease Grades 2 and 3 who were randomly assigned to 2 different groups: the superior rectal artery
embolization group (n = 15) and Ferguson closed hemorrhoidectomy surgical group (n = 14). Four patients were excluded
from the analysis. Pain using the visual analog scale and the use of analgesics were evaluated 3 times daily during the first 7
days of the postoperative period. Recurrent symptoms and satisfaction with treatment were also evaluated in the subse-
quent first, third, sixth, and twelfth months.
Results: The mean pain during the first bowel movement after the procedure was 6.08 ± 4.41 in the surgery group and 0 in
the embolization group (P = .001). The mean use of pain medication was higher in the surgery group (28.92 doses ± 15.78 vs
2.4 doses ± 5.21; P < .001). In the embolization group, the most prevalent preprocedural symptom was bleeding in 14
patients, with complete improvement in 12 (83.3%) patients. Mucus, skin tag, and pruritus were symptoms that showed little
improvement in both groups. The frequency of symptoms (bleeding, pain, prolapse, and pruritus) was similar between the
groups at 12 months (P = .691). No severe adverse events were observed in both groups.
Conclusions: Despite no difference in outcomes, embolization of the superior rectal arteries for the treatment of hemor-
rhoidal disease showed pain levels lower than those observed after surgical treatment.
ABBREVIATIONS
The exact prevalence of symptomatic hemorrhoidal disease years (2). Treatment varies according to the degree of the
is difficult to establish. Although many patients may disease and can be either be nonsurgical (such as pharma-
experience symptomatic hemorrhoids at some point in their cological, banding, and sclerotherapy) or surgical. Surgery
lives (1), the peak incidence occurs between 45 and 65 is indicated in approximately 10% of cases of hemorrhoids
Table E1 can be found by accessing the online version of this article on www. J Vasc Interv Radiol 2023; 34:736–744
jvir.org and selecting the Supplemental Material tab. https://doi.org/10.1016/j.jvir.2023.01.022
© SIR, 2023
Volume 34 Number 5 May 2023 737
the Netherlands) and Allura Clarity Xper FD20/10 biplane of the anoderm) was made, followed by hemorrhoid
(Philips Medical Systems, Eindhoven, Netherlands). Embo- dissection and vascular pedicle ligation.
lization of the rectal arteries was performed with 0.018-inch Excision of the entire internal hemorrhoidal complex
fibered coils (Interlock IDC; Boston Scientific Marlborough, with preservation of the internal and external anal sphincters
Massachusetts) via puncture of the right common femoral was performed. Hemostasis was achieved, and mucosal
artery with a 5-F sheath, followed by catheterization of the defects were submitted to primary closure.
inferior mesenteric artery with a Simmons-2 5-F catheter At the end of the procedure, patients were kept at rest in
(Imager TM-II; Boston Scientific) (Fig 2a) and super postanesthetic recovery, and their vital signs were monitored.
selective catheterization of the superior rectal artery and its After 6 hours, they were discharged home with analgesia.
branches with an angled 150-cm microcatheter (Renegade
STC, Boston Scientific) and 0.016-inch shapeable tip 180-
cm microwire (Fathom; Boston Scientific) (Figs 2b, 3a–c). Outcomes
The level of embolization was mid-third to the distal Postprocedural pain was evaluated according to a ques-
superior rectal artery, and the end point was no further tionnaire for pain assessment and medication use that
opacification of the superior rectal arteries on postembolic patients were instructed to fill out after being randomly
angiography. If opacification of the rectal artery persisted, assigned. Upon hospital discharge, patients received the
additional coils were added. After the procedure, manual questionnaire and were again instructed on how to fill it in
compression was performed for 30 minutes at the puncture and describe the pain level during the first bowel movement
site according to hospital protocol, and the patients (regardless of how many days after the procedure). Spe-
remained recumbent and had their vital signs monitored for cifically, patients assessed pain from 0 to 10 according to
6 hours. They were discharged after this period. VAS 3 times daily (morning, afternoon, and night) in the
first 7 days after treatment. If they experienced any pain and
Surgery. Surgical procedures were performed according to pain medication was necessary, they were instructed to note
the Ferguson closed hemorrhoidectomy technique (11). The the medications and dosage used. At the 7-day return visit,
patient was in the lithotomy position and under spinal the patients delivered the completed questionnaire.
anesthesia and intravenous moderate sedation. An Clinical success was defined as improvement of previous
hourglass-shaped incision (centered on the middle portion hemorrhoidal symptoms presented by patients before
Volume 34 Number 5 May 2023 739
Figure 2. Digital subtraction inferior mesenteric arteriography. (a) Selective angiogram of the inferior mesenteric artery (open
arrow) demonstrated the superior rectal artery (black arrowhead) and its right and left branches (black arrows), the sigmoid
artery (white arrowhead), and the left colic artery (open arrowhead). (b) Subselective angiogram of the superior rectal artery
(black arrow) demonstrated branching into the right anterior (white arrowhead), right posterior (open white arrowhead), left
anterior (black arrowhead), and left posterior (open black arrowhead) branches.
Figure 3. Angiography of the superior rectal artery. (a) Superselective angiogram of the left posterior branch of the superior
rectal artery (open black arrowhead) after coil embolization of the left anterior branch (black arrowhead). (b) Superselective
angiogram of the right superior rectal artery showed branching into anterior (white arrowhead) and posterior (open white
arrowhead) branches. (c) Completion angiogram of the superior rectal artery showed coil embolization of all branches.
treatment. Persistence of preprocedural hemorrhoidal After Day 30 of followup, patients were followed
symptoms or return of symptoms (hemorrhoid bleeding, through telephone calls at 3, 6, and 12 months. Degree of
prolapse, pruritus, mucus, and anal discomfort) and need for satisfaction with treatment was evaluated using a 4-point
retreatment were also evaluated. scale (very satisfied, satisfied, a little satisfied, or unsatis-
fied) and either remission or permanence of the same pre-
Follow-up. Outpatient follow-up was performed at the operative symptoms in the PO period, including whether
clinic for orificial diseases by a team of proctologists and there was any presence of new symptoms.
interventional radiologists during the post-treatment
period: at postoperative Days 7 and 30 for patients in the Procedure Safety. Adverse events (AEs) related to
surgery group and at postprocedural Days 2, 7, and 30 for rectal artery embolization were classified into mild, moder-
patients in the embolization group. ate, severe, life-threating, and death according to the new
740 Superior Rectal Artery Embolization: RCT Falsarella, et al JVIR
Table 1. Demographic Distribution of Patients Included in the Table 2. Postprocedural Pain Assessment
Study
Day Group PGroup PDay PInteraction
Variable Group P value
Surgery (n = 13) Embolization (n = 15)
Surgery Embolization
Pain .001 .003 .561
Sex .464* D1 4.3 ± 3.8 0.5 ± 1.4
Female 7 (53.8) 6 (40) D3 4.6 ± 3.8 1.4 ± 2.7
Male 6 (46.2) 9 (60) D7 3.4 ± 3.4 0.5 ± 1.1
Pain 8 (61.5) 9 (60) .934*
Pruritus 3 (23.1) 5 (33.3) .686† Note–Generalized estimating equation with normal distribution and identity
Bleeding 8 (61.5) 14 (93.3) .069† link function assuming correlation matrix AR(1) between days.
D1 = Day 1; D2 = Day 2; D3 = Day 3.
Others 6 (46.2) 3 (20) .228†
Previous hemorrhoidal surgery 1 (7.7) 2 (13.3) >.999†
Age (y) 54.9 ± 14.2 54.6 ± 9.3 .958‡
BMI (kg/m ) 2
26.5 ± 5.2 26.4 ± 3.6 .935‡
Time of symptoms (y) 8.1 ± 10.7 7.8 ± 7.2 .555§
Patients
A total of 33 patients were included in the study from
July 2018 to March 2020. There was no difference in
baseline features between the 2 patient cohorts (Table 1).
Of the 33 patients included, 29 underwent intervention
for the treatment of hemorrhoidal disease: 15 patients
underwent embolization of the superior rectal arteries Figure 4. Mean estimated pain during the first week.
and 14 patients underwent surgical correction using the
Ferguson hemorrhoidectomy technique. One patient in
the embolization group revoked the consent for
RESULTS
participation, 3 patients in the surgery group missed the
follow-up before the intervention, and 1 patient in the The mean procedural time of embolization was 80 minutes
surgery group missed the follow-up at postoperative (median, 75 minutes; range, 40–120 minutes), and the mean
Day 7. procedural time of the surgical treatment was 59 minutes
(median, 75 minutes; range, 46–78 minutes). The mean
time of ionizing radiation during the procedure was 31
Statistical Analysis minutes (median, 28 minutes; range, 14–60 minutes). The
Pain score in the first 7 post-treatment days, use of mean volume of iodinated contrast medium used per pro-
analgesics, and the amount of analgesics used were cedure was 110 mL.
described according to the groups using summary statis- The number of branches of the superior rectal artery
tics (mean, SD, median, and quartiles) and compared embolized per patient ranged from 2 to 5 branches, with a
between the groups using the generalized estimating mean of 3.2 branches ± 0.96 (median, 3 branches). The
equation with normal distribution and identity link func- number of microcoils used per patient ranged from 3 to 9
tion assuming AR(1) correlation matrix between (mean, 5.06 ± 1.94; median, 5), with a coil size of 2–5 mm.
moments. The outcomes, such as clinical success, main- Embolization of the superior rectal arteries was possible
tenance of preprocedural hemorrhoidal symptoms or in all patients (100% of cases). Among patients who
return of symptoms (hemorrhoid bleeding, prolapse, underwent embolization, no AEs classified as severe, life
pruritus, mucus, and anal discomfort), and need for threatening, or death were observed. Two early AEs were
retreatment, were described according to the groups using observed after the procedure, 1 classified as mild and 1
absolute and relative frequencies. Comparison was per- classified as moderate. A patient in the embolization group
formed using the χ2 test. with benign prostatic hyperplasia who interrupted clinical
Volume 34 Number 5 May 2023 741
In this series, the most prevalent symptom before the Interventional Radiology, Hospital Municipal Vila Santa Catarina Dr Gilson de
Cassia Marques de Carvalho (P.M.F.), Colorectal Department (S.E.A.A.), and
procedure was bleeding in 14 patients, which resolved in 12 Department of Cardiology (M.K.), Hospital Israelita Albert Einstein, São Paulo,
(83.3%) patients, similar to other series in the literature Brazil. Received June 12, 2022; final revision received January 12, 2023;
accepted January 20, 2023. Address correspondence to P.M.F., Center of
(7,9,20). On the contrary, mucus, skin tag, and pruritus Interventional Medicine, Hospital Israelita Albert Einstein, Av. Albert Einstein,
showed little improvement with the embolization treatment. 627/701 - Morumbi, São Paulo - SP, 05652-900, Brazil; E-mail: primina@
These symptoms were not evaluated in other studies gmail.com
M.K. has received personal consulting fees from AbbVie, Eli Lilly, Novo
(9,20,24). Nordisk, Servier, EMS, and Brace Pharma. None of the other authors have
Recently, new embolization techniques have been identified a conflict of interest.
described, such as embolization with coils and particles (25)
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Volume 34 Number 5 May 2023 744.e1
Table E1. Distribution of Symptoms before and after the Procedure in the Embolization Group
Patient Symptoms
*The patient presented prolapse within 10 months of embolization and underwent surgical correction.
†The patient developed an external hemorrhoidal crisis and underwent surgical correction.