A randomized trial of transanal hemorrhoidal dearterialization with anopexy compared with open hemorrhoidectomy in the treatment of hemorrhoids

OBJECTIVE: the aim of this study was to compare early and midterm results of transanal hemorrhoidal dearterialization with anopexy to open hemorrhoidectomy.. DESIGN, SETTINGS, PATIENTS,

484 D iseases of the C olon & R eCtum V olume 56: 4 (2013)

surgery has become more frequent during the past decade the method is mainly studied in nonrandomized trials Data from randomized controlled trials are lacking

OBJECTIVE: the aim of this study was to compare early and midterm results of transanal hemorrhoidal dearterialization with anopexy to open hemorrhoidectomy

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

self-reported symptom questionnaire was answered, and a clinical examination was performed preoperatively, after 2

to 4 months, and after 1 year

was postoperative pain

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).

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

Postoperative pain; Doppler; transanal hemorrhoidal dearterialization; anopexy

hemorrhoidal surgery has evolved from more to

less invasive surgery during the past decade the use of Doppler guidance in hemorrhoidal sur-gery was introduced in the 1990s and has been further developed since the Doppler-guided hemorrhoidal ar-terial ligation (DG-hal) was described by morinaga et

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

Dis Colon Rectum 2013; 56: 484–490 Doi: 10.1097/DCR.0b013e31827a8567

© the asCRs 2013

Funding/Support: this study was supported financially by the

stock-holm Council Public health and medical services Committee R&D Department.

Financial Disclosure: Dr lenander has demonstrated the surgical

tech-nique on 1 occasion at a scientific meeting at Karolinska university hos-pital (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: solveig.el-mer@erstadiakoni.se

LWW

al in 1995.1 By this technique, the submucosal terminal

branches of the superior rectal artery are identified by

us-ing 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

dearterial-ization (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

meth-ods have reported good results and low postoperative pain,

and low complication rates, as well only 2 small

random-ized 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

hemor-rhoidal dearterialization with anopexy (thD/a) is

com-pared 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

reduc-tion, and restoration of anatomy

METHODS

Study Design

Between December 2006 and november 2007, 167

consec-utive patients were scheduled for surgery of hemorrhoidal

disease within the setting of a specialized coloproctologic

department all eligible patients with symptomatic

sec-ond- to third-degree hemorrhoids were considered for a

randomized study comparing thD/a with oh the

hem-orrhoidal grade was estimated on a straining chair

accord-ing 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

reposi-tion; 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

re-quiring surgical treatment suitable for both thD/a and oh

exclusion criteria were acutely thrombosed

hemor-rhoids, 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

liga-tion or sclerotherapy in the past 3 months, oh within 3

years, or any previous operation with hal, thD, or sta-pled 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 sta-pled 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 inves-tigation was done when thought necessary (eg, colonos-copy or Ct colonoscolonos-copy) 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 con-cerned symptoms of hemorrhoids (anal pain, defecatory bleeding, anal pruritus, soiling, and replacement of the prolapse) Because no validated questionnaire for hemor-rhoidal 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

(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

com-plication had occurred a stool softener was advised, and

a scheduled analgesia consisting of 1 g paracetamol and

100 mg dextropropoxyphene 4 times daily was recom-mended 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 numeri-cal Rating snumeri-cale (0 = no pain at all and 10 = the most se-vere 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 (av-erage 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

estimat-ed, and the patients answered the same questionnaire as before surgery

Assessed for eligibility (n = 167)

Analyzed according to ITT principles (n = 20)

♦ Excluded from analysis (n = 0)

Lost to follow-up (n = 0)

Discontinued intervention (n = 0)

Allocated to THD/A (n = 20)

♦ Received allocated intervention (n = 20)

♦ Did not receive allocated intervention (n = 0)

Lost to follow-up (n = 1) One patient did not wish to take part in 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)

Randomized (n = 40)

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)

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.

TABLE 1 Baseline characteristics of patients

THD (n = 20)

OH (n = 19)

Degree of hemorrhoids

THD = transanal hemorrhoidal dearterialization; OH = open hemorrhoidectomy;

IBS = irritable bowel syndrome.

Statistical Analysis

in a comparison of previous data on postoperative pain

after oh14 and data from our own institution on

postop-erative 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

as-sociations between categorical variables

all analyses were made according to

intention-to-treat principles

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

re-ported 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

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 be-fore 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-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 uri-nary catheter for 3 days (1 thD/a; 1 oh) (table 2) two patients in the oh group needed an extra visit to the hos-pital because of bleeding that, however, had stopped spon-taneously 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)

8 6 4 2

Postoperative day

OH THD/A

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.

10 Pain score (median)

8 6 4 2

Postoperative day

OH THD/A

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.

in the thD/a group presented a partial reprolapse within

the first week in these, 1 or 2 sutures had rifted the

mu-cosa 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

success-fully 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

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 com-plication at 2 to 4 months follow-up one had an anal fis-sure (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 re-ported minimal postoperative pain and early recovery.2–8,15 there are 2 small randomized trials comparing Doppler-guided 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 bet-ter well-being in comparison with oh even if there was

a significant difference in peak postoperative pain favor-ing 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

100 Percent

80 60 40 20

Postoperative day

OH

* *

*

*

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.

TABLE 2 Operating time and postoperative complications

THD/A (n = 20)

OH (n = 19)

Operating time, min, mean (range) 36 (30–45) 20 (10–34)

Thrombosed residual hemorrhoid 1

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

hemorrhoidectomy.

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

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 previ-ously 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 con-sumption 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 agree-ment 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 tis-sue 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 posi-tion underestimates the degree of prolapse

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 After 2–4 mo After 1 y THD/A OH THD/A OH THD/A OH

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

*p < 0.05.

18

A

B

16

14

12

10

No of patients

8

6

4

2

Grade 1 Grade 2 Grade 3

OH

THD/A

16

14

12

10

No of patients

8

6

4

2

Grade 1 Grade 2 Grade 3

OH

THD/A

FIGURE 5 Shown is the proportion of different grades of

hemorrhoids in the 2 groups preoperatively (A) and at 1-year

follow-up (B) Data received from examination on a straining chair THD/A =

transanal hemorrhoidal dearterialization with anopexy; OH = open

hemorrhoidectomy.

however, all grades of the hemorrhoids in this

inves-tigation 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

pro-lapse postoperatively in comparison with previous

stud-ies 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

prima-ry end points were obtained from patient questionnaires

by a study nurse not aware of group allocation

other limitations with our study are the small

num-ber 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

com-parison with oh

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