Hemorrhoidal Artery Ligation for the Treatment of Grade II-III Hemorrhoids: Is it Worth the Use of Doppler Guide in Long-Term Follow-Up?: A Single-Center Cohort Study

Abstract

Background:

Hemorrhoidal artery ligation (HAL) may reduce postoperative pain and complications and shorten patients’ recovery when compared to standard hemorrhoidectomy. It is unclear if the Doppler guide (DG) is useful in reducing recurrence risk.

Objective:

To compare two groups of patients (treated with DG-HAL or HAL) in terms of recurrence risk and patients’ satisfaction grade.

Methods:

Between January 1, 2014 and January 31, 2021, 122 patients affected by grade II-III hemorrhoidal prolapse underwent DG-HAL or HAL at Chivasso Hospital, Italy. Mucopexy was routinely performed. After discharge, patients were subjected to 1-week, 1-, 3-, 6-, and 12-month clinical assessment. Thereafter, they were interviewed by telephone annually.

Results:

Seventy-six (62.3%) DG-HAL and 46 (37.7%) HAL procedures were performed. Median surgical time was 30 (15–45) minutes for DG-HAL versus 25 (15–40) minutes for HAL (P = 0.005). No intraoperative complications occurred. Postoperative bleeding needing surgery occurred in 2 (1.6%) patients in the DG-HAL group. During a median follow-up of 46 months (6–86), we registered 18 (23.7%) recurrences in the DG-HAL group and 13 (28.3%) in the HAL one (P = 0.574). No cases of incontinence or anal stenosis occurred. No significant difference was observed between the two groups in terms of patients’ satisfaction. At multivariate analysis, age ≥ 65 years resulted a protective factor for recurrence (odds ratio 0.31; 95% confidence interval 0.09–0.98; P = 0.047).

Conclusions:

In our study, the use of DG did not reduce recurrence risk. Operative time was significantly increased in the DG-HAL group.

Hemorrhoidal artery ligation (HAL) may reduce postoperative pain and complications and shorten patients’ recovery when compared to standard hemorroidectomies. However, it is unclear if the doppler guide (DG) is useful in reducing recurrence risk. The aim of this observational study is to compare 2 groups of patients (treated with DG-HAL or HAL) in terms of recurrence risk and patients’ satisfaction grade.

INTRODUCTION

Hemorrhoidal disease still represents one of the most common anorectal disorders, affecting up to 39% of adult people in Western countries.¹ Prevalence is the same for men and women, increasing with age until the seventh decade.² Despite its benign nature, hemorrhoidal disease has a high social impact, sometimes seriously affecting patients’ quality of life.

Milligan-Morgan open hemorrhoidectomy and Ferguson closed hemorrhoidectomy have always been considered the gold standard for the surgical treatment of hemorrhoidal disease.^3–6 To reduce complications associated with these procedures, including pain, bleeding, anal stenosis and incontinence, surgery has evolved by seeking minimally invasive approaches.^7–9

In 1995 Morinaga introduced a new non-excisional approach to obtain Doppler-guided hemorrhoidal artery ligation (DG-HAL).¹⁰ The main change made to the original technique was the addition of mucopexy to treat prolapse, the extent of which has been suggested as a significant risk factor for disease recurrence.^11,12

In literature, HAL (with or without DG) recurrence risk ranges from 3% to 24%,¹³ while high satisfaction rates are reported (84%–96%).¹⁴

Recently, a new device for HAL without DG has been introduced in clinical practice. HemorPex System® Plus (HPSP, Angiologica B.M. S.r.l., Pavia, Italy) is a rotating proctoscope with an operative window. This instrument allows the surgeon to conduct arterial ligation and mucopexy at 1-3-5-7-9-11 o’clock in the anal canal.

The aim of this single-center retrospective cohort study is to compare DG-HAL and HAL in terms of recurrence risk and patients’ satisfaction grade on long-term follow-up. The secondary aim is to evaluate the duration of hospital stay, postoperative pain, bleeding and tenesmus, development of gas/stool incontinence and anal stenosis occurrence in the two groups.

MATERIALS AND METHODS

Between January 1, 2014 and January 31, 2021, 122 consecutive patients affected by grade II-III hemorrhoidal prolapse underwent surgery with DG-HAL or HAL at Chivasso Hospital—General Surgery Unit, Piedmont, Italy. HPSP has been the only device available at our Institution starting from January 2018 and subsequently routinely used in case of indication for treatment with dearterialization and mucopexy.

Exclusion criteria were contraindications to spinal or general anesthesia, coagulopathy or impossibility to stop anticoagulant therapy, and grade IV hemorrhoids.

The grade of hemorrhoidal prolapse was defined according to Goligher’s classification.¹⁵ All patients received the diagnosis of muco-hemorrhoidal prolapse during a proctological examination which included inspection, digital-anorectal exploration and anoscopy. Surgery was indicated after failure of an adequate dietary regimen and medical therapy, with symptoms (prolapse and/or bleeding) lasting for more than 12 months.

Patients were given spinal anesthesia or, in case of contraindications to this procedure, general anesthesia. No antibiotic prophylaxis was administered. Surgery was performed with the patient in the gynecological position.

DG-HAL and HAL with hemorrhoidopexy both consist of two fundamental surgical steps: ligation of the six main branches of the superior rectal artery, typically located at 1, 3, 5, 7, 9 and 11 o’clock, and execution of a mucopexy to bring prolapsed hemorrhoidal cushions back to their physiological location. The two devices considered in our series, however, have two substantial differences. For DG-HAL we used THD® Doppler (THD S.p.A., Correggio, Italy), a device equipped with DG and a mobile operative window, which is retracted by the surgeon during mucopexy. Once the terminal arterial branch is identified through DG, the surgeon performs ligation and mucopexy suturing towards the dentate line. The maximum diameter of the proctoscope is 32 × 33 mm. On the other hand, HPSP (used for HAL) is equipped with an anchoring system to maintain its position without the help of an assistant, and surgery is performed without DG. HPSP consists of a fixed part and a rotating part. Once the former is anchored to perineal skin using stitches, the latter is rotated to realize arterial ligation and mucopexy (Figs. 1, 2). In this case, the operative window is calibrated to start about 2 cm above the dentate line. This device has an external diameter of 30 mm, ligation sites are localized through movements of the rotating part and the six running sutures are realized moving away from the dentate line (Fig. 3). Arterial ligation and mucopexy are performed using sutures of polyglycolic acid 2/0 and 0 (THD® Doppler and HPSP, respectively, according to the type of suture in the kit). At the end of the procedure, complete prolapsed tissue return into the anal canal should be appreciated (Fig. 4). Hemostatic absorbable sponge is always placed into the anal canal.

FIGURE 1.

Preoperative condition.

FIGURE 2.

The self-anchoring device (HPSP) is placed in the anal canal. The rotating part is moved to realize arterial ligation and mucopexy at 1–3–5–7–9–11 o’clock.

FIGURE 3.

Once the site is identified, arterial ligation and running suture are performed (HAL).

FIGURE 4.

Results after surgery (HAL).

The analgesic protocol for all patients was based on oral paracetamol (1 g × 3), oral ketorolac 10 mg × 3 (1° choice) and oral tramadol 100 mg × 3 (2° choice) as rescue therapy. At the time of discharge, patients were given diet and hygiene information. A psyllium fiber product was prescribed to all patients to help bowel regularity.

All the operations were performed in a One-Day Surgery setting, that is the patients were admitted and discharged home the next day (post-operative day [POD] 1). Patients were discharged after verifying the absence of pain, nausea and bleeding, spontaneous diuresis, tolerance to oral feeding and ambulation.

Data on the postoperative period (90 days after surgery) and long-term follow-up were collected in a prospective database. After discharge from our Unit, patients were subjected to 1-week, 1-, 3-, 6-, and 12-month clinical assessment. Thereafter, they were interviewed by telephone annually. Recurrence was defined as persistence/new onset of prolapse and/or bleeding clinically appreciable or referred by the patient. During follow-up outpatient assessments, the presence and entity of pain (defined with Visual Analogic Scale [VAS], 0–10), bleeding, referred tenesmus, development of gas and/or stool incontinence, anal stenosis occurrence, constipation and recurrence signs were evaluated. During every examination starting from 1-month follow-up, patients were asked to define their degree of satisfaction with the surgery undergone: complete (significantly improved quality of life), partial (persistence of symptoms but better quality of life than preoperative condition) or dissatisfaction (persistence of symptoms with worsened quality of life than preoperative condition and/or postoperative complications significantly affecting the quality of life). The grade of satisfaction reported for each patient in the study corresponds to the assessment during the last follow-up examination/interview. In the case of re-intervention, the satisfaction grade is referred to the last assessment after the second operation.

Intraoperative, postoperative and follow-up results of the two groups were compared. Categorical variables were analyzed with the chi-square test, while for the continuous ones Student t test or Mann-Whitney U test were used as indicated. The significance level was set at 5% for all variables. Sample size analysis or power analysis was not performed since the recurrence risk (main outcome) for both DG-HAL and HAL is reported in the literature as extremely variable, ranging from 3% to 24%. This factor would have affected the reliability of the statistic. The association between recurrence and a set of parameters has been investigated through univariate and multivariate logistic regression analysis on the whole series. Factors considered were male sex, age ≥ 65 years, BMI ≥ 30, smoking, comorbidities, prior anorectal surgery, inflammatory bowel disease, DG during surgery and constipation in the postoperative period. All the analyses were carried out using IBM SPSS 22.0.

RESULTS

We performed 76 DG-HALs and 46 HALs. Patients’ characteristics at baseline are reported in Table 1. There was a prevalence of male sex in the DG-HAL group (67.1% vs 37% of the HAL one). On the whole sample, the average age was 56.1 years (±14) with a prevalence of male sex (n = 68, 55.7%). Eighteen (14.8%) patients had a BMI ≥ 30. Comorbidities were present in 53 (43.4%) cases, with hypertension most represented (n = 38, 31.1%). Smoking habit was detected in 39 (32%) cases. Five (4.1%) patients had a diagnosis of inflammatory bowel disease (3 Crohn disease, 2 ulcerative colitis). Nineteen (15.6%) patients had already undergone anorectal surgery (9 Milligan-Morgan, 3 stapled hemorrhoidectomy, 2 DG-HAL, 5 rubber band ligation). Both patients previously undergoing DG-HAL were again treated with the Doppler-guided approach. One hundred one (82.8%) cases had a grade III muco-hemorrhoidal prolapse. Bleeding symptoms for more than a year were present in 48 (39.3%) patients.

TABLE 1.

Patients’ Characteristics at Baseline

	DG-HAL	HAL	P
	n = 76	n = 46
Male sex	51 (67.1)	17 (37)	0.001
Age (mean, SD)	55 (±15)	57 (±14)	0.549
Body mass index (mean, SD)	25 (±4)	25 (±4)	0.540
Smoking	24 (31.6)	15 (32.6)	0.906
Comorbidities	28 (36.8)	25 (54.3)	0.059
Diabetes	6 (7.9)	5 (10.9)	0.746
Hypertension	20 (26.3)	18 (39.1)	0.139
Heart disease	7 (9.2)	4 (8.7)	0.923
Pulmonary disease	5 (6.6)	5 (10.9)	0.500
Kidney disease	2 (2.6)	0	0.526
Prior anorectal surgery	12 (15.8)	7 (15.2)	0.933
Inflammatory bowel disease	4 (5.3)	1 (2.2)	0.404
Hemorrhoids grade III	64 (84.2)	37 (80.4)	0.592

Bold values indicate statistical significance.

No intraoperative complications occurred. Overall median surgical time was 28 (15–45) minutes. DG-HAL median operative time was 30 (15–45) minutes versus 25 (15–40) minutes of HAL (P = 0.005). Conversion to ordinary hospitalization was necessary in 7 (5.7%) cases, due to acute urinary retention (n = 4) or uncontrolled pain (VAS ≥ 7, n = 3). During hospitalization, we registered moderate (VAS ≥ 4 and ≤ 7) and intense pain (VAS > 7) in 11 (9%) and 2 (1.6%) patients respectively, while 12 (9.8%) cases of acute urinary retention requiring catheterization occurred (all after spinal anesthesia, 10 males). No significant difference was observed between the two groups in terms of moderate/intense pain after surgery (P = 1.000).

We registered 3 (2.5%) acute bleeding in the postoperative period, all in the DG-HAL group. Two (1.6%) patients needed surgical hemostasis, and 1 (0.8%) required blood transfusions.

First bowel motion occurred within 2 days after surgery in 94 (77%) cases. Ninety (73.8%) patients reported complete resumption of daily activities and work during the first 2 postoperative weeks.

No postoperative gas/fecal incontinence and anal stenosis development were registered. Eleven patients in each group developed transient tenesmus after surgery (< 1 year).

Table 2 reports intra- and postoperative results in the two groups. No significant differences between DG-HAL and HAL were observed, except for the operative time.

TABLE 2.

Intraoperative and Postoperative Results

	DG-HAL	HAL	P
	n = 76	n = 46
Operative time (median, range)	30 (15–45)	25 (15–40)	0.005
VAS > 3	8 (10.5)	5 (10.9)	1.000
Bleeding	3 (3.9)	0	0.290
Surgery	2 (2.6)
Transfusion	1 (1.3)
Urinary retention	7 (9.2)	5 (10.9)	0.763
Hospital stay (median, range)	1 (1–4)	1 (1–3)	0.802
Conversion to ordinary hospitalization	5 (6.6)	2 (4.3)	0.709
Constipation	26 (34.2)	21 (45.7)	0.229
Tenesmus	11 (14.5)	11 (23.9)	0.189
Gas incontinence	0	0
Fecal incontinence	0	0
Anal stenosis	0	0
Resumption of daily activities within 2 weeks	55 (72.4)	35 (76.1)	0.651

Bold values indicate statistical significance.

The median follow-up duration for the whole sample was 46 months (6–86). One hundred twelve (91.8%) patients had a follow-up of at least a year. The median follow-up duration was 54 months (6–86) for the DG-HAL group and 32 months (6–54) for the HAL one. Three (2.5%) patients died during the follow-up for causes not related to surgery. Eight (6.6%) patients were lost to follow-up. We registered a total of 31 (25.4%) cases of recurrent disease. Recurrence risk was not significantly different between the two groups (P = 0.574). The analysis of the subgroup of male patients showed no significant difference between DG-HAL and HAL (P = 1.000) in terms of recurrence risk. In 2 (1.6%) cases, following straining due to postoperative constipation, a suture breaking with recurrence occurred. Eight patients with recurrent symptoms in the DG-HAL group and 2 in the HAL one underwent a new surgical procedure: 5 elastic band ligation, 1 Milligan-Morgan, 1 Stapled Trans Anal Rectal Resection, 3 HAL. A single patient developed complete external prolapse of the rectum and was referred to another center for surgical treatment.

Based on responses obtained during the last available follow-up examination/telephone interview, 91 (74.6%) patients reported complete postoperative satisfaction, 18 (14.8%) partial satisfaction and 13 (10.6%) dissatisfaction. In terms of patients’ satisfaction, no difference was observed between the two groups.

Table 3 shows the follow-up results of the two groups.

TABLE 3.

Follow-Up

	DG-HAL	HAL	P
	n = 76	n = 46
Follow-up (median, range)	54 (6–86)	32 (6–54)	<0.0001
Recurrence	18 (23.7)	13 (28.3)	0.574
Prolapse	8 (44.4)	5 (38.5)	0.739
Bleeding	1 (5.6)	1 (7.7)	1.000
Prolapse and bleeding	9 (50)	7 (53.8)	0.833
Time to recurrence (median, range)	18 (1–48)	2 (1–24)	0.135
Grade of symptoms
Minor	12 (66.7)	7 (53.8)	0.470
Same	5 (27.8)	6 (46.2)	0.449
Greater	1 (5.5)	0	1.000
Treatment of recurrence
No therapy	7 (38.9)	5 (38.5)	0.981
Medical therapy	3 (16.7)	6 (46.1)	0.114
Surgery	8 (44.4)	2 (15.4)	0.129
Satisfaction grade
Complete	61 (80.3)	30 (65.2)	0.064
Partial	9 (11.8)	9 (19.6)	0.244
Dissatisfaction	6 (7.9)	7 (15.2)	0.235

Bold values indicate statistical significance.

Univariate binary logistic regression on the whole series identified smoking habit as a risk factor for recurrence (odds ratio [OR] 2.62, confidence interval [CI] 95% 1.13–6.09, P = 0.026), while age ≥ 65 resulted a protective factor (OR 0.27, CI 95% 0.09–0.85, P = 0.025). A stepwise model of multivariate analysis confirmed age ≥ 65 as an independent protective factor for recurrence (OR 0.31, 95% CI 0.09–0.98, P = 0.047). The use of DG did not significantly influence recurrence risk. The results of this analysis are reported in Table 4.

TABLE 4.

Univariate and Multivariate Logistic Regression for Factors That Could Influence Recurrence Development

	Univariate Analysis Recurrence		P	Multivariate Analysis Odds Ratio (95% CI)	P
	Yes (n = 31)	No (n = 91)
	n (%)
Male sex	13 (41.9)	55 (60.4)	0.076
Age ≥ 65	4 (12.9)	32 (35.2)	0.025	0.31 (0.09–0.98)	0.047
Body mass index ≥ 30	5 (16.1)	13 (14.3)	0.803
Smoking	15 (48.4)	24 (26.4)	0.026	2.28 (0.96–5.41)	0.062
Comorbidities	14 (45.2)	39 (42.9)	0.823
Prior anorectal surgery	4 (12.9)	15 (16.5)	0.636
Inflammatory bowel disease	3 (9.7)	2 (2.2)	0.096
DG	18 (58.1)	58 (63.7)	0.574
Constipation after surgery	13 (41.9)	34 (37.4)	0.682

Bold values indicate statistical significance.

DISCUSSION

According to the most recent (2020) guidelines for hemorrhoidal disease diagnosis and treatment,^13,16 HAL is a treatment option for grade II-III hemorrhoids. This procedure, today routinely performed together with mucopexy, is associated with less postoperative pain, complications, shorter operative time and faster recovery when compared to standard hemorrhoidectomy.¹³ However, the recurrence risk is higher than standard hemorrhoidectomy, ranging between 3% and 24%.¹³

It is still debated if the DG may be useful. Three studies comparing DG-HAL and HAL with blind transfixation are available: the former resulted in longer operative time, while no significant difference was observed between the two techniques in terms of recurrence risk.^17–19 DG-HAL and HAL, associated with mucopexy, are similar techniques, as they act on the same pathophysiological elements: blood flow to hemorrhoidal piles and prolapse. In our study, the main differences between the two approaches aforementioned are the absence of DG and the presence of a self-anchoring system in HAL. Our study is the first available in which DG-HAL and HAL performed with HPSP are compared.

Only a few non-comparative series with mid-term follow-ups are available in the literature on the use of the HemorPex System (HPS) for the treatment of muco-hemorrhoidal prolapse. Reported results seem encouraging in terms of less postoperative pain and bleeding, with good patients’ satisfaction rates.^20–22 However, strong evidence is still lacking on HPS efficacy on long-term follow-up. Tagliabue et al. (2015) used HPS to treat 116 patients with grade II-III hemorrhoids. They reported 4 cases (3.4%) of severe bleeding in the postoperative period with the need for surgical revision. Recurrent disease occurred in 6 patients (5.2%). However, the short follow-up was a major limiting factor. In their study, Basile et al. (2016) reported the results of HPS application for grade II-III hemorrhoids on 100 patients. Twenty-four-month follow-up was available for 56 patients: 8.9% reported persistent pain, 5.3% hygiene problems, 16.7% occasional rectal bleeding, and 14.2% prolapse. Five (8.9%) patients required new surgical intervention. Pagano et al. (2018) treated 126 patients with HPS. Thirty-nine patients (31%) had grade IV hemorrhoids. The mean follow-up duration was 554 days (281–1219), and the recurrence rate at 1 year was 4.1%. Results in terms of operative time, postoperative pain and fecal urgency were better in patients with grade III hemorrhoids. In all the studies aforementioned, results were satisfactory in terms of low postoperative pain, resumption of daily activities and patients’ satisfaction grade.

In our series, the incidence of recurrence in long-term follow-up was higher than reported in the literature.^13,20–22 Recurrence rate was 25.4% on the whole sample, 23.7% for DG-HAL and 28.3% for HAL. This may be due to long follow-up duration (> 3 years in 59% of cases) and a high percentage of grade III prolapse (82.8%). Moreover, in our study, we adopted a strict definition of recurrence, which included all grades of postoperative symptoms (bleeding, prolapse).

In our series, 61.3% of patients with recurrence reported less intense symptoms than preoperative conditions, while the overall grade of satisfaction for the intervention was complete or partial in 89.3% of cases. Half of the cases with the need for new intervention were successfully treated in an outpatient setting with rubber band ligation. Patients’ satisfaction grade is probably due to good postoperative pain control and quick recovery of daily activities. In our study, only 2 patients experienced intense pain in the immediate postoperative period (VAS > 7). Acute urinary retention occurred in 9.8% of cases and is related to the standard use of spinal anesthesia. We recorded a few cases (n = 2) of major bleeding requiring surgical revision, in agreement with data reported in the literature.¹³ In these two cases, bleeding occurred during the first postoperative week along the sites of transfixation. DG-HAL and HAL with mucopexy are safe in terms of anal sphincter preservation^11,23 and can also be considered for the treatment of recurrent disease. In this study, no cases of postoperative gas and/or fecal incontinence were observed.

Multivariate analysis identified older age as an independent protective factor for recurrence. Why older age should be a protective factor is not clear. It is possible that younger patients have less compliance in following advice on hygiene and diet prescribed at discharge. Similar evidence was also reported by Ratto et al.²⁴ Based on these results, and considering the higher recurrence rates compared to excisional techniques, older age could represent an indication of choice for artery ligation with mucopexy.

Although constipation is a known risk factor for the development of hemorrhoidal disease, in our series it did not reach statistical significance as a risk factor for recurrence on univariate analysis, probably due to the small sample size. We believe that postoperative constipation is a relevant factor in surgery failure, so we recommend to all patients a diet rich in liquids and fibers and to avoid excessive straining during defecation.

In terms of safety and efficacy, no significant difference between the two surgical approaches described was observed during our follow-up, one of the longest reported so far. DG probably does not provide a clear advantage in identifying the terminal branches of the superior hemorrhoidal artery, while it is associated with longer operative times.²⁵ A study conducted with ultrasonography to define the topography of hemorrhoidal arterial branches showed that most of them are located in the rectal submucosa within 2 cm from the anorectal junction.²⁶ HPSP is designed to have an operative window located about 2 cm above the dentate line, thus allowing a pain-free suture in an area with the greatest probability of arterial branches localization.

Major limitations of this study are its retrospective not randomized design, small sample size and the fact that two surgical techniques were adopted separately, one before and the other after January 2018. This could represent a bias given the growing experience with mucopexy approach. A prospectively collected database and long follow-up, on the other hand, guarantee the high quality of data reported. However, this is the first paper comparing DG-HAL and HAL performed with HPSP on a long follow-up and could represent the basis for a future randomized study to evaluate the effective impact of DG.

In conclusion, good patients’ satisfaction level, sphincters preservation and fewer complications than traditional hemorrhoidectomy make DG-HAL and HAL with mucopexy a valid option for the treatment of hemorrhoidal disease. The use of DG during artery ligation does not seem to reduce recurrence risk.