Medical Policy

This document addresses transanal hemorrhoidal dearterialization (THD), a minimally invasive procedure utilizing Doppler guidance to interrupt the blood supply by ligation of the hemorrhoidal arteries in the lower rectum. Dearterialization by Doppler-guided transanal hemorrhoidal artery ligation is also known as HAL.

Investigational and Not Medically Necessary:

Doppler-guided transanal hemorrhoidal dearterialization is considered investigational and not medically necessary.

THD, an alternative to conventional hemorrhoidectomy or stapled hemorrhoidopexy, interrupts blood circulation by ligating the hemorrhoidal artery in the lower rectum. The artery is located using Doppler equipment. Interrupting blood circulation to the hemorrhoidal artery contributes to shrinkage of the hemorrhoidal cushion and subsequently improves symptoms. Because the ligation is conducted above the dentate line, the pain-sensitive anoderm is preserved.

Giordano and colleagues (2009) conducted a systematic review to assess the current evidence on dearterialization, ascertain the safety and efficacy of the technique, define its indications, and pinpoint its possible advantages and limitations. The primary outcome measures were hemorrhoidal recurrences and postoperative pain. A total of 17 articles (involving 1996 individuals) were analyzed. Overall, the quality of the studies was low. Most of the subjects experienced a 1-day hospital stay and returned to normal activities within a range of 2-3 days. Approximately 18.5% of the subjects experienced postoperative pain. A total of 3 participants experienced significant postoperative hemorrhages. No other major complications were reported. The overall recurrence rate was 9.0% for prolapse, 4.7% for pain at defecation, and 7.8% for bleeding. At 1 year or more follow-up, the recurrence rate was 10.8% for prolapse, 9.7% for bleeding, and 8.7% for pain at defecation. When the results were examined based on hemorrhoidal grade, the recurrence rate was higher for grade IV hemorrhoids (range, 11.1-59.3%). The authors concluded that THD appears to be a potential treatment option for grade II and III hemorrhoids. However, the authors also noted clinical trials with longer follow-up comparing THD to other established procedures used to treat hemorrhoids are needed to determine the possible role of the procedure.

Festen and colleagues (2010) reported results from a randomized trial comparing the procedure for prolapse and hemorrhoids (PPH) and THD in the treatment of grade III and IV hemorrhoids. Subjects with grade III or IV hemorrhoids were randomly assigned to undergo PPH (n=18 individuals) or THD (n=23 individuals). The participants were evaluated postoperatively after 1 week, 3 weeks, and 6 weeks. Resolved symptoms postoperatively at 6 weeks was the primary endpoint. Pain (measured by a visual analogue scale [VAS] after 1 day, 1 week, and 3 weeks), and complications were the secondary endpoints. At 6 weeks postoperatively, the success rates were 83% in the PPH group versus 78% in the THD group. The VAS scores were significantly lower after 1 day and 1 week in the THD group, but were similar after 3 weeks. A total of 12% of the participants after PPH and 4% after THD required an urgent readmission to treat an acute bleeding. Overall, the rate of complications did not differ significantly between the two groups. The authors concluded for grade III and IV hemorrhoids, both PPH and THD are safe interventions with good short-term results and acceptable complication rates. Because the complication rates and short-term results were similar, but less postoperative pain when compared to PPH, THD might be preferred by some. However, the authors noted these preliminary outcomes needed to be validated in larger randomized studies with longer follow-up in order to identify selection criteria.

Ratto and colleagues (2010) performed a retrospective analysis of 170 individuals treated at a single institution with THD from July 2005 through October 2008. Individuals with grade I hemorrhoids were excluded. For individuals with grade II hemorrhoids, enrollment criteria included presentation with significant bleeding and/or prolapse and failure of medical therapy. The procedure involved dearterialization of six arteries in all of the participants, with major mucopexy in 56 subjects (32.9%). General/spinal anesthesia was utilized to treat the first consecutive 11 subjects (6.4%) while sedation with propofol with remifentanil analgesia support was used for the remaining 159 (93.6%) subjects. Participants were evaluated at 2 weeks, 1 and 3 months, and once a year after THD. The mean follow-up period was 11.5 ± 12 (range, 1-41) months. A total of 13 (7.6%) of the participants had grade II hemorrhoidal disease (HD), 141 (82.7%) had grade III disease and 16 (9.6%) had grade IV disease. Surgical intervention for postoperative bleeding was required for 2 cases (1.2%) and hemorrhoidal thrombosis occurred in 4 of the cases (2.3%). There were no cases of chronic pain or fecal incontinence reported. Continued constipation was reported in 49 (28.8%) participants. A total of 50 participants (29.5%) reported hemorrhoidal prolapse at follow-up but prolapse was confirmed in only 18 (10.5%) and the prolapse was mild. During the follow-up period, 7 subjects (4.1%) required surgery for recurrence of HD. The authors concluded that THD appears to be an effective minimally invasive option to treat hemorrhoids and can be carried out in a day-surgery setting. The authors also noted additional controlled trials comparing THD with other procedures are needed to demonstrate the efficacy of the procedure and to define appropriate selection criteria.

In 2011, Gupta reported data from a double-blind, randomized controlled trial involving 48 consecutive individuals requiring surgery for grade III hemorrhoids. The study endpoints were to determine if Doppler-assisted ligation of the hemorrhoid artery prior to mucopexy (DSL) was more advantageous to mucopexy alone (SL). Outcomes were measured by duration of the operation, postoperative morbidity, resolution of hemorrhoidal symptoms, and medium-term recurrence rates. Surgery duration was significantly longer with DSL compared to SL (31 minutes [min] vs. 9 min.; p<0.003). The postoperative pain score was significantly higher for the DSL cohort compared to the SL group (4.4 vs. 2.2; p<0.002) on the visual analogue scale, and the DSL group used higher doses of analgesics for longer periods of time (p<0.01). Between the cohorts, there was no difference in the complication rate. At 1-year follow-up, there was no statistically significant difference in the rate of recurrence in either group. The authors concluded that Doppler-assisted ligation of the hemorrhoid artery did not add extra benefit compared to SL. Limitations of the study included single-center location and medium duration of follow-up. Additional randomized controlled studies in multiple centers with long-term follow-up were recommended.

Elmer and colleagues (2013) compared the early and midterm results of THD with anopexy to open hemorrhoidectomy. A total of 40 participants with grade II to grade III hemorrhoids were randomized to THD with anopexy (group A, n=20) or open hemorrhoidectomy (group B, n=20). Participants kept a diary during the first 2 postoperative weeks to record pain scores. A self-reported symptom questionnaire was completed, and a clinical examination was performed preoperatively, after 2 to 4 months, and after 1 year. Postoperative pain was the primary outcome measure. During the first week, group A had less postoperative peak pain compared to group B (p<0.05); however, there was no difference between the groups for overall pain (p=0.010). Analgesic use was not significantly different between the groups. After 1 year, there were significant improvements (p<0.05) in pain, bleeding, and the need for manual reduction of the hemorrhoids in both groups. Additionally, fecal soiling was decreased using both treatments, however, participants treated with THD had significantly increased fecal soiling after 1 year compared with the open hemorrhoidectomy group. The authors acknowledged that limitations of the study included the small sample size, short follow-up period, the absence of blinding, and use of an unvalidated but frequently utilized questionnaire. Additional studies with longer-term observation are needed to draw conclusions about the utility of this approach.

Pucher and colleagues (2013) reported the results of a systematic review evaluating the safety and efficacy of THD. Primary outcomes were recurrence and postoperative pain. Secondary outcomes included operation time, complications, and reintervention rates. After reviewing the results of 28 studies, including 2904 participants with grade I to IV hemorrhoids, the researchers found that THD demonstrated a hemorrhoid recurrence rate ranging between 3.0% and 60.0% (pooled recurrence rate = 17.5%), with the highest rates for grade IV hemorrhoids. Postoperative analgesia was required in 0% to 38% of participants. Postoperative complication rates revealed an overall bleeding rate of 5.0% and an overall reintervention rate of 6.4%. Operation time ranged from 19 to 35 minutes. The researchers concluded that based on the evidence analyzed in this systematic review, THD appears to offer safe and effective treatment for grade II and III hemorrhoids; however, future randomized and multicenter studies should explore whether Doppler guidance in hemorrhoidal artery ligation is truly necessary.

In 2015, Ratto and colleagues described an observational Italian multicenter study consisting of 803 subjects with Grade II (n=137), III (n=548), and IV (n=118) symptomatic hemorrhoids treated using THD. Those with prolapse also underwent rectal mucopexy. Disease was assessed by a specifically designed symptom questionnaire and scoring system. Treatment failure was defined as the presence of recurrent bleeding or recurrent hemorrhoidal prolapse needing medical or surgical therapy. The overall success rate after a follow-up of less than 12 months was 90.7%. Analysis of subjects with a follow-up of 12 months or greater demonstrated a lower success rate of 86.9%. The authors reported that it is necessary to be very careful to avoid complications as this could affect the long-term outcome. Limitations included the observational nature of the study.

A large systemic review and meta-analysis performed by Simillis and colleagues (2015) compared 98 trials consisting of 7827 subjects and 11 surgical treatments for grade III and IV hemorrhoids. Treatments included open, closed, and radiofrequency hemorrhoidectomies, sub-mucosal hemorrhoidectomy, stapled hemorrhoidectomy, THD, Ligasure^™ and Harmonic^® procedures, laser hemorrhoidectomy, Starion^™ hemorrhoidectomy, and bipolar scissors hemorrhoidectomy. Although some benefits were noted as a result of THD, it also had a higher recurrence rate than open, closed, Ligasure, laser, and radiofrequency hemorrhoidectomies, and “importantly, the highest probability of being the worst treatment for recurrence of hemorrhoids (P=0.785).” The authors concluded that further higher quality randomized controlled trials are needed to compare surgical treatment for hemorrhoids.

Brown and colleagues (2016) reported the results of a trial of 337 participants with symptomatic grade II or III internal hemorrhoids who were randomly assigned (in a 1:1 ratio) to either rubber band ligation (RBL) or THD. Individuals who had previously received any hemorrhoid surgery, more than one injection treatment for hemorrhoids, or more than one RBL procedure within 3 years before recruitment, were excluded from the study. The primary outcome was recurrence at 1 year, based upon the patient's self-reported assessment in combination with resource use from their general practitioner and hospital records. THD resulted in fewer hemorrhoid recurrences than RBL at 12 months follow-up (30% versus 49 %). However, this difference was almost completely accounted for by the need for repeat banding, which is a common practice, but which was considered as a recurrence in this trial. Compared with RBL, THD was associated with more pain at days 1 and 7 following the procedure, more serious adverse events requiring hospitalization (7% versus 1%), and higher cost. The authors noted that more participants withdrew in the THD group than in the RBL group. The primary reason for the difference in withdrawal relates to participants withdrawing consent. A total of 15 participants from the THD group withdrew consent compared with 2 from the RBL group. This difference appears to be primarily related to the waiting time for intervention. RBL was frequently carried out immediately after randomization whereas THD participants were put on a waiting list. In some instances, the waiting list was quite long (up to 270 days). Otherwise, there were no differences in the baseline characteristics for those that withdrew. The authors acknowledged that limitations of the study included but were not necessarily limited to the short follow-up period and a potential prolonged learning curve for surgeons to become competent at performing the THD. Another limitation acknowledged by the authors was the lack of a validated scoring system for hemorrhoids.

Yilmaz and colleagues (2016) reported the results of a study that evaluated the efficacy, safety, and long-term results of THD with a 7-year follow-up period for treatment of grade II and III degree hemorrhoids. Participants were followed up at postoperative 1^st week and 3^rd, 12^th, and 24^th months by physical examination and 7^th year by phone questionnaire using Short Form-36. Between November 2006 and May 2007, a total of 50 participants (29 females, mean age = 38.2) underwent this procedure. All participants were discharged a few hours after the operation and the mean return to work was 2.5 days. No major complications were reported and mean postoperative Visual Analogous Scale at first week was 1.72. At 24 months, 44 (88%), and 38 (76%) participants at 7^th year were symptom free. The researchers concluded that THD is a safe and effective outpatient procedure, which can be used to treat grade II and III HD with satisfactory long-term results; however, recurrence rates increase with longer follow-up periods.

In another study researchers conducted a multicenter RCT that compared THD with mucopexy (n=197) and circular stapled hemorrhoidopexy (SH, n=193) in participants with symptomatic grade II-III hemorrhoids at 22 French hospitals. The primary outcome was operative-related morbidity at 3 months based on the Clavien-Dindo surgical complications grading system. The researchers found that participants in the HAL arm reported lower pain scores during the second week following surgery than participants in the SH group (1.3 vs 1.9, p=0.01), although there was no difference in pain medication requirements (37% versus 44%; p=0.17). At 6 months following surgery, recurrence rates were higher in the HAL group than the SH group (25.1% versus 13.8%; p=0.049). The researchers did not identify any differences between the 2 groups in terms of pain, analgesic requirement, participant satisfaction or quality of life at 12 months after surgery. At 1 year, THD resulted in more residual grade III HD (15% vs 5%) and a higher reoperation rate (8% vs 4%). Participant satisfaction was rated at > 90% for both procedures. The authors concluded that THD and SH are feasible options in grade II/III HD with no significant difference in surgery-related risk. While THD resulted in less postoperative pain and shorter sick leave, it was more expensive, took longer to perform, and provided a possible inferior anatomical correction suggesting an increased risk of recurrence (Lehur, 2016).

Ratto and colleagues (2017) conducted a single-center, retrospective study to evaluate the long-term outcomes of THD. A total of 1000 subjects were given a clinical evaluation and symptoms-based questionnaire before and after the THD procedure. Hemorrhoidal dearterialization and mucopexy were done in 931 subjects, and only dearterialization was done in 69 subjects. Concomitant procedures were done for 243 subjects including: skin tag removal (145), internal lateral sphincterotomy (103), and fistulotomy (10). After THD, 31 subjects (3.1%) required pain medication for more than 5 days, 23 subjects (2.3%) had urinary retention treated with catheterization, 8 subjects (0.8%) had thrombosed external hemorrhoids, and 14 subjects (1.4%) had acute bleeding that required surgical or endoscopic hemostasis. Long-term follow-up ranged from 6-124 months (mean 44 ± 29; median 36). The subjects reported a significant mean reduction on the symptom-based questionnaire (baseline 13.8 ± 2.3 versus last follow-up 1.1 ± 0.8; p<0.0001). A total of 95 subjects (9.5%) had recurrence: bleeding (12; 1.2%), prolapse (46; 4.6%), and bleeding and prolapse (37; 3.7%). A total of 26 subjects (2.6%) needed to reduce prolapsing piles every day, 14 (1.4%) had daily pain, and 12 (1.2%) had a decrease in quality of life. A total of 70 subjects had a redo or second surgery (32 THD, 23 Milligan-Morgan hemorrhoidectomy, 11 Ferguson hemorrhoidectomy, 2 stapled hemorrhoidopexy, and 2 stapled transanal rectal resection). Including the second/redo surgeries, 95.7% of subjects were free of hemorrhoids at final follow-up. There were no reports of defecatory urgency, fecal incontinence, or chronic pain. Limitations of the study included the retrospective design, single-center location, and variable techniques and equipment. The authors concluded that THD “seems a valid therapeutic option for primary HD and selected recurrences.”

In a single-center, longitudinal, comparative study, Trenti and colleagues (2017) compared THD to conventional hemorrhoidectomy for long-term postoperative morbidity and recurrence. A total of 83 individuals underwent either distal Doppler-guided THD with low ligation of the hemorrhoidal artery and mucopexy (n=49) or conventional hemorrhoidectomy (n=34; Milligan and Morgan [n=13] or Ferguson technique [n=21]) for grade III and IV hemorrhoids. Postoperative morbidity was reviewed using medical reports and the prospective database of the colorectal unit. Baseline and recurrent hemorrhoid symptoms were evaluated before surgery and at 1 year postsurgery using a 5-parameter questionnaire (bleeding, prolapse, manual reduction, discomfort or pain, and impact on quality of life). Fecal incontinence was measured preoperatively and at a minimum of 1 year postoperatively using the Vaizey score. A total of 5 individuals were lost to follow-up, 4 in the THD group and 1 in the conventional group. Mean follow-up was 1.9 years for the THD group and 2.89 years for the conventional group. The 30-day postoperative surgical morbidity was 26.5% in the THD group and 8.82% in the conventional group (p=0.085). There were no significant differences between the groups for bleeding, prolapse, need for manual reduction in prolapse, pain, and quality of life. Further surgery was needed for 1 individual in the THD group and 2 individuals in the conventional group. In the THD group, 2 individuals reported persistent postsurgical urgency of defecation at the last follow-up. In the conventional group, 2 individuals reported fecal incontinence. The researchers found that the THD procedure was not inferior to conventional surgery for postoperative complications and long-term symptom relief. The study was limited by a small sample at a single-center, and the researchers noted the need to validate the findings in large, multicenter randomized trials.

Du and colleagues (2019) published a network meta-analysis that compared surgical procedures for individuals with grade III and IV hemorrhoids. They included 21 studies (n=2799) that involved 9 surgical procedures: THD, stapled hemorrhoidectomy, Starion hemorrhoidectomy, Harmonic or ultrasonic scalpel hemorrhoidectomy, Ligasure device hemorrhoidectomy, mucopexy, closed or Ferguson hemorrhoidectomy, open or Milligan-Morgan hemorrhoidectomy, and semi-closed or Park’s hemorrhoidectomy. The overall quality of the studies was determined to be moderate. THD and stapled hemorrhoidectomy were found to be associated with more complications and higher recurrence rates. They noted that further high-quality studies with larger sample sizes and longer follow-up periods are needed.

In 2019, Popov and colleagues reported the results of a prospective study that compared Doppler-guided THD and conventional hemorrhoidectomy for early and long-term postoperative results. The study included a total of 287 subjects who underwent conventional hemorroidectomy (167 cases) or Doppler-guided THD with mucopexy (120 cases) between November 2010 and December 2015. The researchers obtained information on hemorrhoidal stage, demographic data, presenting symptoms, complications, duration of hospital stay, postoperative pain, participants’ satisfaction and follow-up. No significant difference was observed between the studied groups based on gender, mean age, preoperative prolapse, pain and pruritus, hemorrhoidal stage and postoperative complications. Preoperative bleeding occurred more frequently in the THD group (p=0.002). The results of the mean visual analog scale (VAS) pain scores in conventional hemorroidectomy and THD groups on days 1, 2 and 7 were 7.01 vs 5.03, 5.07 vs 2.98, 2.39 vs 0,57 (p=0.000). There was no significant difference in VAS on day 30 and participants’ satisfaction at the 18th month. The mean postoperative follow-up period was 46 ± 16 months (median 45 months, range 18–78 months). During this period, 5 participants (2.99%) in the conventional hemorroidectomy group needed surgery for recurrence. In the THD cohort, 3 subjects (2.5%), all with 4th-degree hemorrhoids, underwent additional procedures (p=0.802). The most frequent reasons for re-operation were recurrent bleeding in the conventional hemorrhoidectomy cohort (3 of 5 individuals) and prolapse in the THD group (2 of 3 individuals). The authors concluded that Doppler-guided THD appeared to be a safe and efficient option for treatment of hemorrhoids and resulted in lower postoperative pain and similar long-term outcomes compared to conventional hemorroidectomy. For advanced grades of hemorrhoids, Doppler-guided THD could be a valuable alternative, but there is a need for patient selection. The authors acknowledged that limitations of the study include a limited number of participants, the lack of randomization, variation in the grade of hemorrhoids included and validated questionnaires were not used.

Emile and colleagues (2019) reported the results of a meta-analysis designed to review randomized trials that compared THD and stapled hemorrhoidopexy to determine which technique provides superior results in terms of recurrence of hemorrhoids, complications, and postoperative pain. Persistent or recurrent HD was the primary endpoint. The secondary endpoints included postoperative pain, complications, readmission, return to work, and participant satisfaction. A total of six randomized trials including 554 participants (THD = 280; SH = 274) were included. The mean postoperative pain score for THD was significantly lower than stapled hemorrhoidopexy (2.9 ± 1.5 versus 3.3 ± 1.6). More participants (13.2%) experienced persistent or recurrent hemorrhoids after THD versus 6.9% after SH (OR = 1.93, 95% confidence interval [CI], 1.07–3.51; p=0.029). Recorded complications were less frequent (17.1%) in the participants who underwent THD versus 23.3% of individuals who underwent stapled hemorrhoidopexy (OR = 0.68, 95% CI, 0.43–1.05; p=0.08). The average duration to return to work post THD was 7.3 ± 5.2 versus 7.7 ± 4.8 days after stapled hemorrhoidopexy (p=0.34). Grade IV hemorrhoids were significantly associated with persistent or recurrent HD after both procedures. The researchers concluded that THD had a significantly higher rate of persistent or recurrent hemorrhoids compared to SH. Complication and readmission rates, hospital stay, return to work, and participant satisfaction ratings were similar in both groups.

Rorvik and colleagues (2020) conducted an open-label randomized controlled trial that compared the patient-reported symptoms following minimal open hemorrhoidectomy versus THD. The study included a total of 102 participants with grade II to IV symptomatic hemorrhoids (Golghar’s classification) who were randomly allocated (in a 1:1 ratio) to either the open (n=48) or TRD (n=50) group. Study participants were assessed in the outpatient clinic at inclusion and at planned 3- and 12-month postoperative follow-up. Secondary outcome measures included health-related quality of life, postoperative pain, participant satisfaction, recovery, recurrence, adverse events and hospital costs. With regards to the primary outcome, the authors reported no difference in symptom score 1 year postoperatively. In completed cases, the HDSS (median [range]) post MOH was 3 (0–17) and following THD 5 (0–17; Mdiff = -1.0 (95% CI, -3.0 to 0.0; p=0.15). The authors reported residual hemorrhoidal prolapse (p=0.008) and treatment for recurrence (p=0.013) was more frequently reported following TED compared to open hemorrhoidectomy. Participant satisfaction was greater following minimal open hemorrhoidectomy (p=0.049). No group-wise differences were identified in the impact on average or peak postoperative pain, recovery, health-related quality of life, or adverse events. Limitations of the study include, but are not limited to its small sample size, the single institution setting, the absence of blinding and the short follow-up period of 12 months.  

Giordano and colleagues (2021) reported the results of a prospective study that assessed the safety and efficacy of adjunct mucopexy to conventional dearterialization. The procedure, which has been referred to as the THD Anolift, consisted of two parts: one focused on the dearterialization and the other aimed at the management of the prolapsing component. After the identification and transfixation of the arteries was completed, an Anolift targeted mucopexy was performed using a continuous barbed suture with a synthetic absorbable monofilament (Polydioxanone) 2/0 Filbloc (Assut Europe) stitch mounted on a 4/8 30 mm needle. All of the Anolift procedures in this study were performed by a single surgeon. Researchers utilized the Hemorrhoidal Assessment Severity Score (HASS) to quantify the severity of hemorrhoidal symptoms. From May 2018 to November 2020, a total of 60 individuals with HD underwent a THD Anolift procedure. Concomitant procedures were carried out in 5 cases (2 Botox injections, 2 skin tag removals, 1 open lay submucosal fistula, and 1 single nodule hemorrhoidectomy). Post-operatively, 3 subjects (5%) complained of severe post-operative pain which settled within 7 days in all cases. Four individuals experienced fecal impaction (6%), and 10 (16%) reported some difficulty in evacuation which all resolved within 5 days. The median follow-up period was 15.5 months (range 2–32 months). The mean HASS improved from 16.43 pre-operatively to 1.95 post-operatively (p<0.0001). Pre-operative HASS was strongly correlated with the degree of hemorrhoids (p<0.001), while there was no correlation between the pre-operative HASS or the degree of hemorrhoids and the post-operative HASS (p=0.163). Researchers did not identify any significant difference in predicted post-operative HASS according to the pre-operative HD stage. One subject (1.6%) with circumferential IV hemorrhoids had a recurrence and required an additional THD procedure. Two participants underwent skin tag excision (3%). While the authors concluded that the Anolift technique is safe and effective for the management of HD even in individuals with advanced stages, they also acknowledged limitations of the study included its single center design, lack of a control group and the surgical procedure being performed by a single surgeon. The authors also acknowledged that a larger multicenter study, with a control group, could further assess the role of the THD Anolift in the management of symptomatic hemorrhoids.

Saleem and colleagues (2023) reported the results of an RCT that compared the outcomes of open hemorrhoidectomy versus Doppler-guided THD with recto-anal repair in 3^rd and 4^th degree hemorrhoids. The study was conducted at a single institution and included 70 participants (49 [70%] males and 21 [30%]) females. Participants underwent open hemorrhoidectomy (Group A) or Doppler-guided THD (Group B). Outcomes assessed post-operative pain, bleeding and length of hospital stay. The researchers found that mean post-operative pain on day 7 for participants in Group A was 1.12 ± 0.72 and 1.06 ± 0.52 for Group B. Post-operative bleeding was 1.9 ± 0.30 in Group A and 1.86 ± 0.34 in the Group B. Mean hospital stay for open procedure group was 2 ± 0.45 and 1.20 ± 0.40 for Groups A and B, respectively. Overall, the researchers found there was a significant difference in terms of mean hospital stay between the two groups, but no significant difference in mean postoperative pain on day 7 or in postoperative bleeding.

Trenti and colleagues (2023) published the findings of a multicenter, randomized controlled trial designed to evaluate the long-term outcomes of THD with mucopexy versus vessel-sealing device hemorrhoidectomy for grade III to IV hemorrhoids. All participants were at least 18 years of age with symptomatic grade III and IV internal hemorrhoids and were randomly assigned to THD (n=39) or vessel-sealing device hemorrhoidectomy (n=41). Proctoscopy or anoscopy or and endoanal ultrasonography were completed in the outpatient clinic prior to the operation. The Giordano questionnaire was used to assess baseline hemorrhoid-related symptoms (discomfort or pain, prolapse, manual reduction, bleeding, and impact on quality of life). Data collection was based on office visits at 2 years post surgery and reviews of participants’ electronic medical records between December 2017 and December 2019. Endoanal ultrasonography was carried out 3 months post surgery to evaluate anal sphincter integrity. The primary endpoint was persistent or recurrent HD which was assessed at 2 years postoperatively. Secondary endpoints included long-term complications, reoperations, fecal continence and participant satisfaction and quality of life. Five of the 80 participants included in the study were lost to follow-up. Thirty-six participants randomly assigned to THD and 39 participants randomly assigned to vessel-sealing device hemorrhoidectomy were included in the long-term analysis. The mean baseline and mean 2-year score in both groups were similar (-11.0, SD 3.8 vs -12.5, SD 3.6; p=0.080). Three participants in the THD group underwent supplementary procedures for hemorrhoid symptoms, compared with none in the vessel-sealing device hemorrhoidectomy group (p=0.106). Four individuals in the vessel-sealing hemorrhoidectomy group and none in the THD group experienced chronic opened wound (p=0.116). The researchers concluded that THD with mucopexy is associated with symptom recurrence similar to vessel-sealing device hemorrhoidectomy at 2 years. Some limitations of the study include the number of participants with grade IV hemorrhoids was higher in the THD group than in the vessel-sealing hemorrhoidectomy group. There was also the absence of blinding for both the participants and the surgeons because although the THD procedure does not involve wounds, the vessel-sealing hemorrhoidectomy procedure is excisional.

Giuliani and colleagues (2023) conducted a multicenter retrospective study designed to compare THD and conventional excisional hemorrhoidectomy for grade III hemorrhoids. The primary aims of the study were to evaluate the adoption of the 2 surgical techniques and to compare them in terms of symptoms, postoperative adverse events, and recurrences at a 24-month follow-up. Data from a total of 1681 participants were analyzed. Both the postoperative clinical score by multiple regression analysis and matched case–control analysis were comparable in both groups. Participants who underwent excisional hemorrhoidectomy had a significantly higher risk of postoperative complication (adjusted OR = 1.58; p = 0.006). The results of a secondary analysis underscored that excisional hemorrhoidectomy performed with new devices and THD reported a significantly lower risk for complications than excisional hemorrhoidectomy performed with traditional monopolar diathermy. At the 24-month follow-up evaluation, recurrence was significantly higher in the THD cohort (adjusted OR = 0.50; p = 0.001). A secondary analysis did not demonstrate a higher risk of recurrences based on the type of device. The authors concluded that while THD is an effective option for grade III hemorrhoidal disease; it is encumbered the increased risk of recurrence. Excisional hemorrhoidectomy performed with newer devices is competitive in terms of postoperative complications. The authors acknowledged that limitations of this study included it nonrandomized, retrospective design. Other limitations include the relatively short follow-up period of 24 months and the many different practitioners who performed surgery and their different levels of surgical experience, although a minimum of 30 surgical procedures per year for HD was required to participate in the study.

Also in 2023, Gachabayov and colleagues reported the results of multicenter, prospective study that compared the 1 year recurrence rate as well as the short-term and long-term postoperative outcomes and quality of life between THD with mucopexy and Ferguson hemorrhoidectomy. Participants included adults at least 18 years of age with prolapsed, nonincarcerated, reducible internal hemorrhoids in at least 3 columns. The primary endpoint was recurrence, which was defined as prolapsed internal hemorrhoids detected by a colorectal surgeon during physical examination at a minimum of 1-year follow-up. Secondary endpoints included postoperative pain scores and postoperative complications (urinary retention, constipation [requiring laxative or emergency room visit], dysuria, pruritis ani, anal pain, anal stenosis, unhealed wound, anal fissure, fecal incontinence and urgency. Participant reported satisfaction and outcomes were evaluated using the Visual Pain Scale and Brief Pain Inventory, Fecal Incontinence Quality of Life (FIQOL) score, Cleveland Clinic Incontinence Score, Constipation Score, Short Form 12 (SF-12) score and the Patient satisfaction (4-point Likert) scale. Twenty surgeons enrolled a total of 197 participants. Of those, 96 participants underwent THD with mucopexy and 101 Ferguson hemorrhoidectomy. One participant from the THD arm was excluded from the study due to the incidental finding of anal cancer requiring radiotherapy. Four participants were excluded from the Ferguson hemorrhoidectomy arm as a result of the site withdrawing from participation in the study. A total of 25 participants (11 in the THD arm and 14 in the Ferguson hemorrhoidectomy arm) were lost to follow-up. Study results demonstrated that the participants that underwent THD reported had lower Visual pain scores at postoperative day (POD) 1 (6.2 vs 8.3, P=0.047), POD7 (4.5 vs 7.7, P=0.021), POD14 (2.8 vs 5.3, P<0.001), and lower medication use at POD14 (23% vs 58%, P<0.001). Participants were followed for a median 3.1 (1.0–5.5) years. Recurrence rates did not differ significantly between the THD with mucopexy and Ferguson hemorrhoidectomy (5.9% vs 2.4%, P=0.253). Patient satisfaction rate was higher following THD at POD14 (76.4% vs 52.5%, P=0.031) and 3 months (95.1% vs 63.3%, P=0.029), but did not differ at 6 months (91.7% vs 88%, P=0.228) and 1 year (94.2% vs 88%, P=0.836). The authors concluded that THD with mucopexy results in improved participant-reported outcomes and quality of life as compared with Ferguson hemorrhoidectomy without significant difference in recurrence rates. Limitations of this study include its nonrandomized design and participants being limited to those presenting with internal hemorrhoids in at least 3 columns.

According to the American Society of Colon and Rectal Surgeons (ASCRS; Hawkins, 2024):

Doppler-guided hemorrhoid artery ligation may be used for patients with internal hemorrhoids. Compared with excisional hemorrhoidectomy, this approach may result in decreased pain but increased recurrence rates. Strength of Recommendation: Conditional based on moderate-quality evidence.

In its guidelines on the “Management of Benign Anorectal Disorders”, the American College of Gastroenterology indicates that “doppler-guided procedures such as hemorrhoidal artery ligations have similar outcomes to hemorrhoidectomy for symptomatic grade 3 hemorrhoids”. However, the authors indicate that this is a conditional recommendation based on very low quality evidence (Wald, 2021).

The joint guidelines from the World Society of Emergency Surgery and American Association for the Surgery of Trauma (WSES-AAST,) state “No recommendation can be made regarding the role of Doppler-guided hemorrhoidal artery ligation and stapled anopexy in patients with bleeding anorectal varices and failure of medical treatment, local and radiological procedures, based on the available literature” (Tarasconi, 2021).

THD appears to be a promising, less invasive treatment option for symptomatic internal hemorrhoids. There are published reviews, retrospective case series, and several studies of THD and THD in combination with procedures for prolapsed hemorrhoid (PPH). THD has demonstrated encouraging but mixed results in terms of pain, operation time, and complications. Larger, multicenter studies comparing THD with the gold standard procedures used to treat symptomatic hemorrhoids and longer follow-up are needed to establish a possible role for this technique and to identify selection criteria.

Hemorrhoids are amongst the most common anorectal complaints. It has been estimated that approximately 10-20% of individuals with symptomatic hemorrhoids require surgery. Hemorrhoidal symptoms vary and may include painless rectal bleeding, tissue protrusion, and drainage of mucous. The traditional therapeutic strategies to treat hemorrhoids include surgical as well as nonsurgical treatment. Nonsurgical interventions may include ensuring adequate fluid intake, increasing dietary fiber, avoiding straining with defecation, rectal suppositories, and Sitz baths. Other conservative interventions such as infrared photocoagulation, injection sclerotherapy, and RBL have been used to fixate the hemorrhoid’s cushion. If conservative interventions are ineffective, surgical treatments may be used.

The conventional hemorrhoidectomy is accepted by most surgeons as the gold standard for the treatment of hemorrhoids that have not responded to conservative management. Milligan-Morgan’s and Ferguson’s procedures are the most commonly used surgical techniques. Although these techniques tend to yield excellent results and tend to have low complication rates, they are usually associated with significant postoperative pain. In order to reduce pain, alternative procedures, including but not limited to THD, are being explored.

In 2008, the U.S. Food and Drug Administration (FDA) issued a 510K approval for the THD Slide system (S.p.a Medical Division, Correggio, Italy; THD America, Inc., Natick, MA). The approved indication for the THD Slide Doppler-guided proctoscope system was for the surgical treatment of second and third degree hemorrhoids. The approval was based on predicate devices with similar acoustic emissions.

Classification of internal hemorrhoids:

Grade I      Prominent hemorrhoidal vessels, no prolapse
Grade II    Prolapse with Valsalva and spontaneous reduction
Grade III   Prolapse with Valsalva requires manual reduction
Grade IV   Chronically prolapsed manual reduction ineffective

Ligation: A procedure where a structure is bound or tied.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure code or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Atallah S, Maharaja GK, Martin-Perez B, et al. Transanal hemorrhoidal dearterialization (THD): a safe procedure for the anticoagulated patient? Tech Coloproctol. 2016; 20(7):461-466.
2. Brown SR, Tiernan JP, Watson AJM, et al. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet. 2016; 388(10042):356-364.
3. Bhatti MI, Sajid MS, Baig MK. Milligan-Morgan (open) versus Ferguson haemorrhoidectomy (closed): A systematic review and meta-analysis of published randomized, controlled trials. World J Surg. 2016;40(6):1509-1509.
4. De Nardi P, Capretti G, Corsaro A, Staudacher C. A prospective, randomized trial comparing the short- and long-term results of doppler-guided transanal hemorrhoid dearterialization with mucopexy versus excision hemorrhoidectomy for grade III hemorrhoids. Dis Colon Rectum. 2014; 57(3):348-353.
5. Du T, Quan S, Dong T, Meng Q. Comparison of surgical procedures implemented in recent years for patients with grade III and IV hemorrhoids: a network meta-analysis. Int J Colorectal Dis. 2019; 34(6):1001-1012.
6. Elmer SE, Nygren JO, Lenander CE. A randomized trial of transanal hemorrhoidal dearterialization with anopexy compared with open hemorrhoidectomy in the treatment of hemorrhoids. Dis Colon Rectum. 2013; 56(4):484-490.
7. Emile SH, Elfeki H, Sakr A, Shalaby M. Transanal hemorrhoidal dearterialization (THD) versus stapled hemorrhoidopexy (SH) in treatment of internal hemorrhoids: a systematic review and meta-analysis of randomized clinical trials. Int J Colorectal Dis. 2019; 34(1):1-11.
8. Festen S, van Hoogsraten MJ, van Geloven AA, Gerhards MF. Treatment of grade III and IV haemorrhoidal disease with PPH or THD. A randomized trial on postoperative complications and short-term results. Int J Colorectal Dis. 2009; 24(12):1401-1405.
9. Gachabayov M, Angelos G, Orangio G, et al. Transanal hemorrhoidal dearterialization with mucopexy versus Ferguson hemorrhoidectomy for prolapsed internal hemorrhoids: A multicenter prospective study. Ann Surg. 2023; 278(3):376-382
10. Giamundo P, Salfi R, Geraci M, et al. The hemorrhoid laser procedure technique vs rubber band ligation: a randomized trial comparing 2 mini-invasive treatments for second- and third-degree hemorrhoids. Dis Colon Rectum. 2011; 54(6):693-698.
11. Giordano P, Overton J, Madeddu F, et al. Transanal hemorrhoidal dearterialization: a systematic review. Dis Colon Rectum. 2009; 52(9):1665-1671.
12. Giordano P, Schembari E. Transanal hemorrhoidal dearterialization (THD) Anolift-prospective assessment of safety and efficacy. Front Surg. 2021; 8:704164.
13. Giuliani A, Romano L, Necozione S, et al. Excisional hemorrhoidectomy versus dearterialization with mucopexy for the treatment of grade III hemorrhoidal disease: The EMODART3 multicenter study. Dis Colon Rectum. 2023; 66(12):e1254-e1263.
14. Gupta PJ, Kalaskar S, Taori S, Heda PS. Doppler-guided hemorrhoidal artery ligation does not offer any advantage over suture ligation of grade 3 symptomatic hemorrhoids. Tech Coloproctol. 2011; 15(4):439-444.
15. Lehur PA, Didnee AS, Faucheron JL, et al. Cost-effectiveness of new surgical treatments for hemorrhoidal disease: A multicentre randomized controlled trial comparing transanal doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy. Ann Surg. 2016; 264(5):710-716.
16. Popov V, Yonkov A, Arabadzhieva E. Doppler-guided transanal hemorrhoidal hemorrhoidectomy for treatment of hemorrhoids – early and long-term postoperative results. BMC Surg. 2019; 19(1):4.
17. Porrett LJ, Porrett JK, Ho YH. Documented complications of staple hemorrhoidopexy: a systematic review. Int Surg. 2015; 100(1):44-57.
18. Pucher P, Sodergren M, Lord A, et al. Clinical outcome following Doppler-guided haemorrhoidal artery ligation: a systematic review. Colorectal Dis. 2013; 15(6):e284-e294.
19. Ratto C, Campenni P, Papeo F, et al. Transanal hemorrhoidal dearterialization (THD) for hemorrhoidal disease: a single-center study on 1000 consecutive cases and a review of the literature. Tech Coloproctol. 2017; (12):953-962.
20. Ratto C, Donisi L, Parello A, et al. Evaluation of transanal hemorrhoidal dearterialization as a minimally invasive therapeutic approach to hemorrhoids. Dis Colon Rectum 2010; 53(5):803-811.
21. Ratto C, Parello A, Veronese E, et al. Doppler-guided transanal haemorrhoidal dearterialization for haemorrhoids: results from a multicentre trial. Colorectal Dis. 2015; 17(1):10-19.
22. Rorvik HD, Campos AH, Styr K, et al. Minimal open hemorrhoidectomy versus transanal hemorrhoidal dearterialization: the effect on symptoms: an open-label randomized controlled trial. Dis Colon Rectum. 2020; 63(5):655-667. 
23. Saleem I, Shirazi A, Farooq S, et al. Comparison of outcome between open haemorrhoidectomy versus trans-anal doppler guided hemorrhoidal artery ligation with recto-anal repair in 3rd and 4th degree haemorrhoids. J Ayub Med Coll Abbottabad. 2023; 35(1):95-98.
24. Schuurman J, Borel Rinkes I, Go P. Hemorrhoidal artery ligation procedure with or without Doppler transducer in grade II and III hemorrhoidal disease: a blinded randomized clinical trial. Ann Surg. 2012; 255(5):840-845.
25. Simillis C, Thoukididou SN, Slesser AA, et al. Systematic review and network meta-analysis comparing clinical outcomes and effectiveness of surgical treatments for haemorrhoids. Br J Surg. 2015; 102(13):1603-1618.
26. Trenti L, Biondo S, Espin-Basany E; et al. Transanal hemorrhoidal dearterialization with mucopexy versus vessel-sealing device hemorrhoidectomy for grade III to IV hemorrhoids: Long-term outcomes from the THDLIGA randomized controlled trial. Dis Colon Rectum. 2023; 66(8):e818-e825.
27. Trenti L, Biondo S, Galvez A, et al. Distal Doppler-guided transanal hemorrhoidal dearterialization with mucopexy versus conventional hemorrhoidectomy for grade III and IV hemorrhoids: postoperative morbidity and long-term outcomes. Tech Coloproctol. 2017; 21(5):337-344.
28. Yilmaz, I., Karakaş, D. O., Sucullu, I Long-term results of hemorrhoidal artery ligation. Am Surg. 2016; 82(3):216-220.
29. Zampieri N, Castellani R, Andreoli R, Geccherle A. Long-term results and quality of life in patients treated with hemorrhoidectomy using two different techniques: Ligasure versus transanal hemorrhoidal dearterialization. Am J Surg. 2012; 204(5):684-688.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Hawkins AT, Davis BR, Bhama AR, et al. The American Society of Colon and Rectal Surgeons clinical practice guidelines for the management of hemorrhoids. Dis Colon Rectum. 2024. Epub ahead of print.
2. U.S. Food and Drug Administration 510(k) Premarket Notification Database. THD Slide. No. K081429. Rockville, MD: FDA. May 16, 2008. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf8/K081429.pdf. Accessed on March 24, 2024.
3. Tarasconi A, Perrone G, Davies J, et al. Anorectal emergencies: WSES-AAST guidelines. World J Emerg Surg. 2021; 16(1):48.
4. Wald A, Bharucha AE, Limketkai B, et al. ACG clinical guidelines: management of benign anorectal disorders. Am J Gastroenterol. 2021; 116(10):1987-2008..

1. U.S. National Library of Medicine. Hemorrhoids. Last updated: August 24, 2020. Available at: http://www.nlm.nih.gov/medlineplus/hemorrhoids.html. Accessed on March 24, 2024.

Transanal hemorrhoidal dearterialization (THD)
Transanal hemorrhoidal artery ligation (HAL)

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.