ORIGINAL CONTRIBUTION

A Randomized Trial of Transanal Hemorrhoidal
Dearterialization With Anopexy Compared With
Open Hemorrhoidectomy in the Treatment of
Hemorrhoids
Solveig E. Elmér, M.D. • Jonas O. Nygren, M.D., Ph.D. • Claes E. Lenander, M.D., Ph.D.
Department of Surgery, Ersta Hospital, Institute of Clinical Sciences at Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden

BACKGROUND:  Doppler guidance in hemorrhoidal
surgery has become more frequent during the past
decade. The method is mainly studied in nonrandomized
trials. Data from randomized controlled trials are lacking.

self-reported symptom questionnaire was answered, and a
clinical examination was performed preoperatively, after 2
to 4 months, and after 1 year.

OBJECTIVE:  The aim of this study was to

was postoperative pain.

compare early and midterm results of transanal
hemorrhoidal dearterialization with anopexy to open
hemorrhoidectomy.

RESULTS:  Postoperative peak pain was lower in group A
during the first week than in group B (p < 0.05), whereas
no difference in overall pain was noted. More patients
expressed normal well-being in group A (p = 0.045).
Pain, bleeding, and the need for manual reduction of the

hemorrhoids were all improved in both groups after 1
year (p < 0.05). Soiling had decreased after both methods
at early follow-up. After 1 year, soiling was significantly
decreased only after open hemorrhoidectomy. The grade of
hemorrhoids was significantly reduced after 1 year for both
methods, but there was a trend to more patients with
remaining grade 2 hemorrhoids in group A (p = 0.06).

DESIGN, SETTINGS, PATIENTS, AND
INTERVENTIONS:  Forty patients with grade 2 to 3

hemorrhoids were randomly assigned to transanal
hemorrhoidal dearterialization with anopexy (group A,
n = 20) or open hemorrhoidectomy (group B, n = 20). A
diary was used during the first 2 postoperative weeks. A
Funding/Support: This study was supported financially by the Stockholm Council Public Health and Medical Services Committee R&D
Department.
Financial Disclosure: Dr Lenander has demonstrated the surgical technique on 1 occasion at a scientific meeting at Karolinska University hospital (without reimbursement) and on 3 occasions to smaller groups
of surgeons in smaller hospitals. During those latter occasions, he was
reimbursed from the THD Company for the loss of income on that
day only (leave without pay from his employer). All this was after the
completion of this study and after collection of the data. Drs Elmér and
Nygren have no conflicts of interest or financial ties to disclose.
Presented at the meeting of the European Society of Coloproctology,
Nantes, France, September 24 to 27, 2008. Published as an abstract in
Colorectal Dis. 2008;10(suppl2).
Clinical Trial Registration: Karolinska Clinical Trial Registry CT200918.
Correspondence:  Solveig Elmér, M.D., Department of Surgery, Ersta
Hospital, Box 4622, S-11691, Stockholm, Sweden. E-mail:
Dis Colon Rectum 2013; 56: 484–490

DOI: 10.1097/DCR.0b013e31827a8567
© The ASCRS 2013

484

MAIN OUTCOME MEASURE:  The main outcome measure

LIMITATIONS:  There was no blinding, the sample
size was small, and follow-up was for only 1 year. The
questionnaire was not validated.
CONCLUSION:  The difference in postoperative pain
between transanal hemorrhoidal dearterialization with
anopexy and open hemorrhoidectomy may be less than
expected based on previous literature.

KEY WORDS:  Hemorrhoids; Hemorrhoidectomy;
Postoperative pain; Doppler; Transanal hemorrhoidal
dearterialization; Anopexy.

H

emorrhoidal surgery has evolved from more to
less invasive surgery during the past decade. The
use of Doppler guidance in hemorrhoidal surgery was introduced in the 1990s and has been further
developed since. The Doppler-guided hemorrhoidal arterial ligation (DG-HAL) was described by Morinaga et
Diseases of the Colon & Rectum Volume 56: 4 (2013)


485


Diseases of the Colon & Rectum Volume 56: 4 (2013)

al in 1995.1 By this technique, the submucosal terminal
branches of the superior rectal artery are identified by using a Doppler flow meter and subsequently ligated. This
causes a decrease in the arterial inflow to the piles, leading
to shrinkage of the hemorrhoidal tissue and a reduction of
the prolapsed mucosa. Transanal hemorrhoidal dearterialization (THD) is a similar method described by Sohn et al2
in 2001, and, in 2002, further developed by Dal Monte et
al,3 adding an anopexy of the prolapsed mucosa. Until now,
several nonrandomized studies3–9 performing these methods have reported good results and low postoperative pain,
and low complication rates, as well. Only 2 small randomized trials have been performed that describe short-term
and midterm results of the DG-HAL operation.10,11 In the
present prospective randomized study, transanal hemorrhoidal dearterialization with anopexy (THD/A) is compared with conventional open hemorrhoidectomy (OH).
The primary outcome was postoperative pain. Secondary
outcomes were postoperative well-being, operating time,
return to work, complications, midterm symptom reduction, and restoration of anatomy.

METHODS
Study Design

Between December 2006 and November 2007, 167 consecutive patients were scheduled for surgery of hemorrhoidal
disease within the setting of a specialized coloproctologic
department. All eligible patients with symptomatic second- to third-degree hemorrhoids were considered for a
randomized study comparing THD/A with OH. The hemorrhoidal grade was estimated on a straining chair according to the Goligher classification (grade 1, hemorrhoids
without prolapse or with prolapse into the anal canal;
grade 2, hemorrhoids with prolapse outside of the anus
and then spontaneously relapsing; grade 3, hemorrhoids
prolapsing outside of the anus needing manual reposition; grade 4, hemorrhoids that were prolapsed outside
of the anus). All cases were examined and performed as
day-case surgery by 1 single colorectal surgeon (C.L.), who

is well experienced in OH and in THD/A. The study was
approved by the local ethics committee, and all patients
signed a written informed consent.
Inclusion criteria were symptomatic (bleeding, pain,
pruritus, soiling, and prolapse) hemorrhoids grades 2 to 3 requiring surgical treatment suitable for both THD/A and OH.
Exclusion criteria were acutely thrombosed hemorrhoids, anal fissure, anal abscesses, anal fistulas, inability
to understand the study instructions, age more than 80
years, continuous consumption of analgesics, IBD, fecal
incontinence, anal stenosis, bleeding disorder, and rectal
prolapse. Patients who had undergone rubber band ligation or sclerotherapy in the past 3 months, OH within 3

years, or any previous operation with HAL, THD, or stapled anopexy were excluded.
Patient Selection

Forty patients were included in the study. Of 127 patients
that were not included, 59 were not considered suitable for
both methods; 13 had previously undergone THD or stapled anopexy, 16 had other proctologic conditions, 4 were
not able to understand the instructions, 3 had IBD, and 22
met other exclusion criteria as stated above. Ten patients
were seen by a consultant other than C.L. in the office, and
they were not included in the study. One patient cancelled
the operation. The flow of all patients through the study
is shown in Figure 1. Baseline characteristics are shown in
Table 1.
At the first visit, all patients were examined in the left
lateral position and on a straining chair. An anoscopy and
a rigid sigmoidoscopy were performed, and further investigation was done when thought necessary (eg, colonoscopy or CT colonoscopy). All hemorrhoids were classified
grades 1 to 3, and the patients answered a standardized
questionnaire comprising 35 questions covering bowel
habits, continence, and anal function. Five questions concerned symptoms of hemorrhoids (anal pain, defecatory

bleeding, anal pruritus, soiling, and replacement of the
prolapse). Because no validated questionnaire for hemorrhoidal disease was available, we used a questionnaire used
in clinical practice and in previously published studies.12
The frequency of each symptom (never, less than once a
week, 1–6 times per week, and every day (always)) was
reported. Stratification for irritable bowel syndrome was
done according to the Rome 3 criteria.
Performance

All operations were planned as day-case surgery, and a
cleaning enema was given preoperatively. No antibiotics
were given pre- or postoperatively. The randomization
between THD and OH was done by a research nurse.
Sealed envelopes were used and opened in the operating
room. Surgery was performed under general anesthesia
with the addition of a preoperative perianal block13 in
the lithotomy position. Open hemorrhoidectomy was
performed without a retractor. The external component
was grasped by a forceps, and the hemorrhoids were
excised up to the anorectal ring by the use of diathermy for
dissection and hemostasis. No ligations were performed,
and the wounds were left open. The number of excisions
was individualized (2 large excisions in 9 patients and 3
excisions in 10 patients), and adequate mucosal and skin
bridges were left between them. For arterial ligation and
anopexy, the THD instrument (G.F. Medical Division,
Corregio, Italy) was introduced to reduce the anal prolapse
and to locate the arteries by using the incorporated Doppler
probe. Six terminal branches of the superior rectal artery



486

Elmér et al: Thd/A vs Open Hemorrhoidectomy

Assessed for eligibility (n = 167)

Enrollment

Excluded (n = 127 )
♦ Not meeting inclusion criteria (n = 59)
Not suitable due to exclusion criteria (n = 43)
♦ Declined to participate (n = 3 )
Excluded due to other reasons (n = 22)
Randomized (n = 40)

Allocation

Lost to follow-up (n = 0)

Lost to follow-up (n = 1)

Discontinued intervention (n = 0)

One patient did not wish to take part in follow-up

Analysis

Follow-up


Allocated to Open hemorrhoidectomy (n = 20)
♦ Received allocated intervention (n = 19)
♦ Did not receive allocated intervention (n = 1)
(1 patient did not want to undergo surgery)

Allocated to THD/A (n = 20)
♦ Received allocated intervention (n = 20)
♦ Did not receive allocated intervention (n = 0)

Analyzed according to ITT principles (n = 20)
♦ Excluded from analysis (n = 0)

Analyzed according to ITT principles (n = 18)
♦ Excluded from analysis (n = 0)

FIGURE 1.  Flow of all patients through the study. THD/A = transanal hemorrhoidal dearterialization with anopexy; ITT, intention to treat.

(located at 1, 3, 5, 7, 9, and 11 o’clock (anterior midline
representing 12 o´clock)) were identified and ligated with
a figure-8 stitch in all cases except 1 (8 ligations). With the
same suture, an anopexy was performed by a continuous
running suture making 2 to 4 mucosal stitches ending at
least 5 mm above the dentate line.3
The patients were discharged when pain relief was
adequate, they were able to pass urine, and no early complication had occurred. A stool softener was advised, and
TABLE 1.  Baseline characteristics of patients

Age, y, mean
Sex ratio (M:F)
IBS, Rome III criteria

Degree of hemorrhoids
 Second
 Third

THD
(n = 20)

OH
(n = 19)

58
8:12
 3

55
8:11
 2

 3
17

 3
17

THD = transanal hemorrhoidal dearterialization; OH = open hemorrhoidectomy;
IBS = irritable bowel syndrome.

a scheduled analgesia consisting of 1 g paracetamol and
100 mg dextropropoxyphene 4 times daily was recommended to be reduced gradually as needed. All patients
were encouraged to return to work as soon as possible. For

evaluation, the patient filled in a diary covering the first
14 postoperative days. Pain was scored daily on a Numerical Rating Scale (0 = no pain at all and 10 = the most severe pain imaginable). There were 2 different pain scores
for pain each day, one regarding the worst pain sensation
that day (peak pain) and one in which the patients were
asked to assess the average pain during the whole day (average pain). Well-being was assessed daily with a single
question whether well-being was as normal or worse than
normal. Dose of analgesics, any complications, whether
or not they had returned to work, and any need to see a
practitioner during this period were registered. A clinical
evaluation was performed (by C.L.) after 8 to 12 weeks
(median, 12; range, 9–23) and after 12 months (median,
12; range, 11–15). The grade of hemorrhoids was estimated, and the patients answered the same questionnaire as
before surgery.


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Diseases of the Colon & Rectum Volume 56: 4 (2013)

Pain score (median)
10

*
*

8

*

*


OH
THD/A

*

6
4
2
1

2

3

4

5

6
7
8
9
Postoperative day

10

11

12


13

14

FIGURE 2.  Peak pain scores for each group the first 14 postoperative days. Values are given as median. *p < 0.05. THD/A = transanal
hemorrhoidal dearterialization with anopexy; OH = open hemorrhoidectomy.

Statistical Analysis
In a comparison of previous data on postoperative pain
after OH14 and data from our own institution on postoperative pain after THD/A, in a prestudy of 11 patients (data
on file), a 2 SD difference in postoperative pain scores was
found between those procedures. Sample size calculation,
with a power of 0.8 and α-level of 0.05, demonstrated that
17 evaluable patients were needed in each group, and thus
20 patients in each group were chosen for this study.
Nonparametrical statistics were used (Wilcoxon
signed rank test and Mann-Whitney U test for paired and
unpaired comparisons) or Fisher exact test for crude associations between categorical variables.
All analyses were made according to intention-totreat principles.

the groups (Fig. 3). Significantly more patients presented
normal well-being in the THD/A-group. In the THD/A
group, patients reported normal well-being for a median
of 8 of 14 days (range, 0–13) and in the OH group for 3
of 14 days (range, 0–13) (p = 0.045) (Fig. 4). The use of
analgesics was similar among the groups. For the THD/A
group, consumption of dextropropoxyphene continued
until day 9 (median; range, 0–14) and for the OH group
until day 8 (median; range, 0–14) (p = NS). Fourteen of

the 20 patients operated on with THD/A were working before the procedure, and they returned to work on day 12
(median; range, 1–25) in comparison with the OH group
in which 10 of 19 patients worked, and they returned to
work on day 14 (median; range, 1–22) (p = NS).
Complications. Twelve patients had thirteen complica-

RESULTS
Early Postoperative Results
Postoperative Pain and Well-being. Duration of surgery

was longer for THD/A (36 vs 20 minutes p < 0.001 vs OH).
The peak pain scores were significantly lower in the
THD/A group for 5 days during the first week (p < 0.05
vs OH) (Fig. 2). A peak pain score of more than 3 was reported for a median of 7 days (range, 0–13) in the THD/A
group in comparison with 12 days (range, 5–14) in the OH
group (p = 0.010) The overall pain did not differ between

tions within the first 30 days; 7 patients developed urinary
retention (4 THD/A; 3 OH), 5 of them were admitted
overnight (3 THD/A; 2 OH), and 2 of them required a urinary catheter for 3 days (1 THD/A; 1 OH) (Table 2). Two
patients in the OH group needed an extra visit to the hospital because of bleeding that, however, had stopped spontaneously. One patient in the THD/A group presented a
thrombosed hemorrhoid, and another in the same group
needed reintervention after 4 days because of severe pain.
Two sutures were found to be too close to the dentate line,
and cutting of these resulted in pain relief. Three patients

Pain score (median)
10

OH

THD/A

8
6
4
2
1

2

3

4

5

6
7
8
9
Postoperative day

10

11

12

13


14

FIGURE 3.  Average pain scores for each group during the first 14 postoperative days. Values are given as median. p = NS. THD/A = transanal
hemorrhoidal dearterialization with anopexy; OH = open hemorrhoidectomy; NS = not significant.


488

Elmér et al: Thd/A vs Open Hemorrhoidectomy

Percent

*

100

OH
THD/A

80

*
*

*

*

60
40

20
1

2

3

4

5

6
7
8
9
Postoperative day

10

11

12

13

14

FIGURE 4.  Proportion of patients reporting normal well-being during the first 14 postoperative days. *p < 0.05. THD/A = transanal
hemorrhoidal dearterialization with anopexy; OH = open hemorrhoidectomy.


in the THD/A group presented a partial reprolapse within
the first week. In these, 1 or 2 sutures had rifted the mucosa causing a partial reprolapse. For one of the patients,
a reintervention with OH was scheduled, but the patient
healed spontaneously. For the other 2, it was decided to
wait until the 1-year follow-up, 1 patient was then successfully treated with rubber band ligation, and the other was
scheduled for OH.
Results from Follow-up
Reduction of Symptoms and Residual Hemorrhoids. Each

symptom was examined separately. Pain, bleeding, and
the need for manual reduction of hemorrhoids were all
improved in both groups after 1 year (p < 0.05). Soiling
decreased in both groups after 2 to 4 months (p < 0.05).
After 1 year, it was significantly decreased only after OH
(Table 3).
When examined on a straining chair preoperatively,
34/39 patients had hemorrhoids grade 3 in comparison
with 20/39 patients when examined in the left lateral
position. After 1 year, 3/39 patients had remaining
grade 3 hemorrhoids examined on a straining chair in
comparison with 1/39 in the left lateral position. The grade
of hemorrhoids before surgery and after 1 year is shown
in Figure 5. Only data from examination on the straining
chair are given. At the 1-year follow-up, 2 patients in the
THD/A group had remaining grade 3 hemorrhoids in
comparison with 1 patient in the OH group, whereas the
TABLE 2.  Operating time and postoperative complications

Operating time, min, mean (range)
Postoperative complications

Urinary retention
Secondary hemorrhage
Thrombosed residual hemorrhoid
Partial reprolapse
Reoperation

THD/A
(n = 20)

OH
(n = 19)

36 (30–45)
8
4

20 (10–34)
5
3
2

1
3
1

THD/A = transanal hemorrhoidal dearterialization with anopexy; OH = open
hemorrhoidectomy.

number of patients with remaining grade 2 hemorrhoids
was 7 in the THD/A group versus 3 in the OH group. This

apparent difference was not significant (p = 0.06).
Complications and Reinterventions. Two patients with
preoperatively circumferential hemorrhoids undergoing
OH needed further treatment at 2 to 4 months follow-up;
1 patient had another OH, and the other was treated with
rubber band ligation. Two patients in the THD/A group
needed further surgery; 1 patient had a reprolapse at the
first follow-up and was reoperated with THD/A, and the
other had skin tags removed owing to hygienic problems.
At the 1-year follow-up, 3 patients had rubber band or
sclerotherapy (2 THD/A; 1 OH). Four patients had a complication at 2 to 4 months follow-up. One had an anal fissure (OH), 2 reported gas incontinence (OH), and 2 had
a discrete anal stricture (1 THD/A; 1 OH). Both of these
latter patients had a sense of difficulty when emptying the
bowel. However, all of these problems had disappeared
at the 1-year follow-up, and no late complications were
noted.

DISCUSSION
Treatment of hemorrhoids with OH is associated with
severe postoperative pain. Since Doppler-guided ligation
was introduced, several nonrandomized studies have reported minimal postoperative pain and early recovery.2–8,15
There are 2 small randomized trials comparing Dopplerguided ligation and OH.10,11 In these studies, anopexy was
not performed. This is the first randomized controlled
trial in which Doppler-guided ligation in combination
with anopexy has been compared with conventional OH.
Despite the small size of the study, this randomized trial
shows that THD/A gives less postoperative pain and better well-being in comparison with OH. Even if there was
a significant difference in peak postoperative pain favoring THD/A, the difference between the study groups was
smaller than we expected based on previously published
data, and we could not verify any difference in overall pain

during the first 2 weeks between the methods.


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Diseases of the Colon & Rectum Volume 56: 4 (2013)

TABLE 3.  Number of patients reporting each symptom once a week or more preoperatively, at follow-up after 2 to 4 months, and after 1 year
Preoperatively

Bleeding
Pain
Soiling
Pruritus
Manual reposition

After 2–4 mo

After 1 y

THD/A

OH

THD/A

OH

THD/A


OH

14
10
13
 7
10

11
13
17
 8
12

2*
2*
3*
3
0*

0*
1*
1*
5
1*

3*
2*
6
1*

4*

0*
0*
3*
2
1*

THD/A = transanal hemorrhoidal dearterialization with anopexy; OH = open hemorrhoidectomy.
*p < 0.05.

Adding the anopexy in the present study is probably
the main reason why postoperative pain after THD/A was
higher than we expected. Adding a suture mucopexy to
the DG-HAL technique is shown to increase postoperative
discomfort significantly.16
A
No. of patients
18
OH
16

THD/A

14
12
10
8
6
4

2
Grade 1

Grade 2

Grade 3

Grade 2

Grade 3

B
No. of patients
16
14

OH
THD/A

12
10
8
6
4
2
Grade 1

FIGURE 5.  Shown is the proportion of different grades of
hemorrhoids in the 2 groups preoperatively (A) and at 1-year followup (B). Data received from examination on a straining chair. THD/A =
transanal hemorrhoidal dearterialization with anopexy; OH = open

hemorrhoidectomy.

THD/A was also associated with better well-being in
the early postoperative period.
One reason for better well-being and less
postoperative pain after THD/A might be that the patients
did not experience any open anal wounds that might cause
inconvenience. One might wonder whether the current
results would have been same if the anal wounds after OH
had been closed (as described by Ferguson) in this study.
However, 3 randomized controlled trials have compared
Ferguson with Milligan-Morgan,17–19 and they show no
advantages in postoperative outcome regarding pain. It
remains to be studied, whether a comparison between
THD/A and OH with closing of the anal wounds by using
the Ferguson technique would have another outcome.
Even if postoperative pain was lower and well-being
better in the THD/A group, there was no corresponding
difference in analgesics consumption or earlier return to
work. Consumption of analgesics was higher than previously described. The explanation for this might be that the
patients were told to start on a maximal dose and then
lower it gradually, which may have resulted in higher consumption than if the instruction had been on demand as
in the study by Bursics et al.10 Data on return to work are
difficult to interpret, because, in this already small study,
many patients were retired or unemployed.
At 1-year follow-up in our study, only 2/20 patients in
the THD/A group reported bleeding once a week or more
in comparison with 12/20 before surgery, which is in agreement with other studies.20 We could see a trend, however,
not significant, toward more patients with remaining grade
2 hemorrhoids after THD/A than after OH after 1 year.

It may be argued that THD/A with regard to reducing
the prolapse is inferior to OH where the hemorrhoidal tissue is surgically removed.
At the 1-year control, 4 patients reported that they still
needed to reduce the mucosal prolapse manually. This is
not in concordance with the number of only 2 patients
with remaining grade 3 hemorrhoids at examination on
the straining chair and only 1 patient with remaining
grade 3 hemorrhoids in the left lateral position. In 1 of the
4 patients, the prolapse consisted of skin tags, but for the
others it is likely that examination in the left lateral position underestimates the degree of prolapse.


490

However, all grades of the hemorrhoids in this investigation were classified at a straining chair, which seems to
be better related to symptoms. Examination on a straining
chair may thus result in more significant remaining prolapse postoperatively in comparison with previous studies where evaluation commonly was performed in the left
lateral position.
Disadvantages with THD/A are the longer duration of
surgery (36 vs 20 minutes compared with OH) as well as
the cost of the THD instrument. This should be weighted
to the advantages for THD/A, as leaving no wounds and
no risk of incontinence or other serious complications
were reported.
There are several limitations to this study. There was
no blinding; we thought it would be impossible to disguise
the anal wounds adequately. The clinical examination at
follow-up was done by C.L. who also had performed the
surgical procedures. On the other hand, data for all primary end points were obtained from patient questionnaires
by a study nurse not aware of group allocation.

Other limitations with our study are the small number of patients and the relatively short follow-up (1 year),
and the use of a nonvalidated questionnaire, as well. The
sample size is too small to conclude whether THD/A
is comparable to OH when it comes to the reduction of
symptoms and the restoration of anatomy.

CONCLUSION
THD/A is a safe method without serious complications
and it is suitable for day-case surgery. The difference in
postoperative pain in comparison with OH may be smaller
than previously noted. There are indications that THD/A
gained more satisfied patients in the short term in comparison with OH.
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