Hybrid Vs Pure Hemorrhoidal Artery Ligation for the Treatment of Hemorrhoids: A Retrospective Study

doi:10.21203/rs.3.rs-2734541/v1

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Hybrid Vs Pure Hemorrhoidal Artery Ligation for the Treatment of Hemorrhoids: A Retrospective Study

https://doi.org/10.21203/rs.3.rs-2734541/v1

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Purpose: Hemorrhoids are a common etiology of anal discomfort affecting up to half of the population. Treatment of hemorrhoids is variable; the choice of treatment is dependent on their grading. Surgical excision via conventional hemorrhoidectomy (CH) remains the gold standard treatment for high grade hemorrhoids. Transanal hemorrhoidal dearterialization (THD) is a less painful alternative to CH but associated with higher recurrence rates. A hybrid procedure has been recently adopted at the American University of Beirut Medical Center (AUBMC) in which hemorrhoidal artery ligation and conventional hemorrhoidectomy are combined. The aim of this study was to compare the recurrence rate between the pure hemorrhoid artery ligation procedure and the hybrid procedure as treatment modalities for hemorrhoids.

Methods: A retrospective study was done at AUBMC comparing patients who underwent the hybrid procedures with those who underwent the pure THD. The patients were followed up to 5 years with a mean follow up of 6 months.

Results: Our results showed that the hybrid procedure was associated with a lower recurrence rate than the pure procedure (5.7% Vs 13 %, p-value 0.155). In addition, the hybrid group has a lower rate of complications.

Conclusion: The hybrid procedure comprises a novel technique for the treatment of hemorrhoids. It provides a safe alternative with lower complications rate compared to the pure procedure. Moreover, it provides a recurrence rate comparable to conventional hemorrhoidectomy with decreased postoperative pain.

Hemorrhoids

Hemorrhoidal Artery Ligation

Transanal Hemorrhoidal Dearterialization

Hemorrhoidectomy

Hemorrhoids are a common cause of anal discomfort with a wide array of symptoms such as soiling, itching, pain and bleeding.¹ Hemorrhoids are thought to affect up to half of the population. ^1-3 Hemorrhoids are naturally occurring swellings of the submucosal veins of the anal canal. They serve as anal cushions.^2,4 While the pathophysiology of symptomatic hemorrhoids is not well understood, it is thought that they arise due to alterations in the venous drainage resulting in dilatation of the venous plexus.⁴

Treatment of hemorrhoids is variable; the choice of treatment is dependent on their grading.⁴ Treatment modalities vary from conservative medical therapy to office based procedures to surgical intervention.^2,4,5 The use of stool softeners as wells as high fiber diets and topical medications are preferred for low -grade hemorrhoids.⁶ In addition, several clinic-based procedures such as rubber band ligation, during which a band is placed on the hemorrhoids in order to decrease their blood supply and thus reduce their size, are suitable options for low- grade hemorrhoids. Although these procedures are cheap, less invasive, and have low complications rates, they have a high rate of recurrence.^2,4,7 Surgical intervention remains the treatment of choice for high grade hemorrhoids as well as grade II hemorrhoids refractory to conservative therapy.^8,9

Conventional hemorrhoidectomy, whether via the open Milligan-Morgan or the closed Ferguson approach, is the gold standard treatment of hemorrhoids. ⁹ Variations of conventional surgery such as stapled hemorrhoidectomy provide a less painful alternative to patients.¹⁰ A relatively newer treatment modality known as Doppler guided Transanal hemorrhoidal dearterialization (THD) was described by Morinaga in 1995. ^6,10 The advantages of THD lie in its shorter operative time and limited postoperative pain.^7,10 This novel technique involves the suture ligation of the hemorrhoidal artery under Doppler transducer guidance. In addition, THD involves mucopexy of the redundant mucosa. ^3,7

A hybrid procedure has been recently adopted at the American University of Beirut Medical Center (AUBMC) in which hemorrhoidal artery ligation and conventional hemorrhoidectomy are combined.¹¹ The aim of this study was to compare the recurrence rate between the pure hemorrhoid artery ligation procedure and the hybrid procedure as treatment modalities for hemorrhoids.

This is a retrospective analysis of patients with hemorrhoidal disease who underwent surgery at AUBMC between January 2012 and November 2017. Ethical approval to conduct this study was obtained from the American University of Beirut Institutional Review Board prior to initiation. The data were collected by reviewing the medical charts and clinic visit notes corresponding to the patients. The recurrence rate of the hybrid procedure is compared to that of the pure hemorrhoidal artery ligation procedure. Both procedures were done by the same surgeon under proper anesthesia and as per surgical requirements. For the pure hemorrhoidal artery ligation, the AMI HALRAR probe was connected and the hemorrhoidal arteries were approached all around the anal verge around 6 cm from the dentate line in the 1,3,5,7,9, and 11 o’clock positions. Then, each patient received 6 ligations of 6 arteries located 6 cm above the dentate line using a Pegasorb 2/0 vicryl suture with 5/8 needle and under Doppler guidance from the HALRAR probe. In addition, each of the above ligations were continued as running suture mucopexy all the way down to half a centimeter above the dentate line and then tied to the original ligation suture causing adequate reduction of all the prolapsed mucosa back into the anal verge. For the hybrid procedure, the grade IV hemorrhoid to be excised using a Milligan Morgan (MM) approach was identified. The open MM hemorrhoidectomy using standard electrocautery cutting settings of 20 for the skin and fulguration setting of 35 for the submucosal dissection with the Valleylab Forcetriad platform generator (Medtronic, Mineanapolis MN). During the MM hemorrhoidectomy all internal anal sphincter fibers were dissected off the hemorrhoid plexus and spared with dissection carried all the way up to the feeding pedicle of the hemorrhoid plexus where then it was clamped and the plexus cut using tissue scissors and the pedicle was then tied off with a suture ligature using 2/0 vicryl suture (J&J New Brunswick, New Jersey USA). Hemostasis was then achieved in the surgical bed with electrocautery when needed. Then the AMI HALRAR probe was then connected and the hemorrhoidal arteries were approached all around the anal verge around 6 cm from the dentate line in the 1,3,5,7,9, and 11 o’clock positions, without the two arteries corresponding to the plexus excised by MM approach in that particular patient. Thus, each patient received 4 ligations of four arteries located 6 cm above the dentate line using a Pegasorb 2/0 vicryl suture with 5/8 needle and under Doppler guidance from the HALRAR probe. This was followed by the running suture mucopexy.¹¹

Outcomes were measured using independent t- test. An alpha level of 0.05 was used to indicate statistical significance. SPSS version 23.0 was adopted for the data entry and analysis. Tables and charts were generated on Microsoft Excel.

Our study included 175 patients over the period extending from January 1, 2012 to November 30, 2017. Follow up period ranged from 2 weeks to 62 months with a mean follow up time of 6 months. Out of the 175 patients, 122 patients underwent pure type hemorrhoidectomy while 53 patients underwent the hybrid procedure. The two groups had similar characteristics in term of mean age, mean follow up time, Body mass index (BMI), and percentage of patient with smoking history.

However, two thirds of the patients who underwent pure hemorrhoidectomy were males whereas less than half of those who underwent the hybrid procedures were males. In addition, the majority of patients who underwent the hybrid procedure had external hemorrhoids (N= 39, 73.6%) whereas only 28 individuals had external hemorrhoids in the pure group (22.8%).

Among the pure group, only one patient had a history of liver disease, 10 patients had cardiac disease, and 37 patients reported a history of constipation. In addition, 24 patients reported using medications and topical creams for their hemorrhoids. As for hemorrhoid grading, 9 patients had grade II hemorrhoids, 98 had grade III hemorrhoids, and 15 patients had grade IV hemorrhoids.

Among the hybrid procedure group, two patients had cardiac disease, 21 patients reported a history of constipation and none of them had liver disease. In addition, only 8 individuals reported the use of medications and topical creams for the treatment of hemorrhoids at time of presentation. As for hemorrhoid grading, 1 patient had grade I hemorrhoids, 5 patients had grade II hemorrhoids, 31 patients had grade III hemorrhoids, and 16 patients had grade IV hemorrhoids.

In terms of complications, the pure group had in general a higher complication rate. The recurrence rate in the pure group was found to be 13 % vs 5.7 % in the hybrid group. Among the pure group, 10 of the cases of recurrence occurred within 12 months whilst the remaining 6 recurrences occurred after at least 24 months with 2 cases occurring after 48 months. Similarly, within the hybrid group, all recurrences occurred within 12 months with recurrences occurring at 6 months, 8 months, and 11 months.

In addition, 9 patients (7.4 %) had post-operative bleeding in the pure group whereas only one patient had post-operative bleeding in the hybrid group (1.9%). Furthermore, one patient in each of the two groups had anal stricture following surgery. None of the patients included in the study had urinary retention or fecal incontinence as a complication of either procedure. Among both groups, all of the complications occurred within 2 years of the date of surgery with the majority of complications occurring within 6 months.

Table 1. showing the general characteristics of the study population

Table 2. showing the complication rates among the different surgery type

Hemorrhoids remain the most common anorectal pathology in western countries. Hemorrhoids pose a huge burden on the health system in terms of cost and workload. ¹ Whilst conventional hemorrhoidectomy remains the optimal modality for treatment of hemorrhoids, it is associated with severe post-operative pain.⁹ As such, the need arises to develop novel procedures which provide symptomatic relief with low complication rates as well as acceptable recurrence rates.

Our study has shown that the hybrid procedure provides a safe alternative with lower complications rate compared to the pure procedure. The percentage of patients who developed post-operative bleeding was less in the hybrid group than that of the pure group. However, the rate of anal stricture was slightly higher in the hybrid group. Moreover, the recurrence rate in the hybrid procedure group was lower as well. Among our patient population, majority of patients had grade III hemorrhoids (80.3% for the pure group and 58.5 % for the hybrid group).

In a study conducted by Ratto et al. on 1000 patients who underwent transanal hemorrhoidal dearterialization (THD), the recurrence rate in patients with grade II, III and IV hemorrhoids were 8.5 %, 8.7 % and 18.1 % respectively. ⁸ A systemic review done in 2015 revealed that the pooled recurrence rate after THD was 17.5%. ¹² Our study revealed that our recurrence rate for the pure group (13%) was comparable to that found in literature while the recurrence rate for our hybrid group (5.7%) was lower than that found in the literature.

Trenti et al. reported that THD was not inferior to CH in terms of recurrence. ⁵ A meta-analysis including 8 randomized control trials done by Song et al. showed no difference between THD and stapled hemorrhoidectomy on long term follow up. ¹⁰ On the other hand, a meta-analysis of 6 RCTs done by Emile et al. showed that THD had a higher recurrence rate than stapled hemorrhoidectomy.⁶

Another study comparing Stapled hemorrhoidectomy (SH) and conventional hemorrhoidectomy showed that the rate of patient reported recurrence in the stapled procedure were 32 % and 44 % at 12 and 24 months respectively.¹ The rate of patient reported recurrence for conventional hemorrhoidectomy was found to be 14 % and 25 % at 12 and 24 months respectively.¹ These rates are higher than the recurrence rate seen in our study for the hybrid procedure group. This rate is also comparable to the lowest recurrence rates stated in literature reaching 4 %. ¹³ Furthermore, the percentage of patients with an adverse event was 7 % in the SH group and 9 % in the CH group.¹ The complication rates of anal stricture and bleeding were minimal using the hybrid technique (1.9%).

To our knowledge, this technique is a novel procedure only previously described by our study group. ¹¹ We applied this technique on patients having different grades of hemorrhoids such as combined moderate grade III and III as well as hemorrhoids with an external component. As such, those with resilient prolapse were excised traditionally whereas the other moderate grade II- III hemorrhoids were treated using HAL. The aim of our approach was to come up with a novel technique which would minimize post-operative pain and the risk of recurrence. Our rationale was to utilize traditional hemorrhoidectomy’s low recurrence rate for hemorrhoids with external components as well as Hemorrhoidal artery ligation’s low pain scores. ^14-16 Our hypothesis is that decreasing the number of incisions in the anal canal will decrease post-operative pain score. However, no objective pain assessment was done to our patients to validate this hypothesis. A randomized control trial published by De Nardi et al. did not show any difference between THD and hemorrhoidectomy in terms of post-operative pain.¹⁷ However, our original study showed that only 14.5% of hybrid procedure patients required opioids in the first three days post op.¹¹

Our study had several limitations. It is a retrospective cohort study based on reviewing patient records. Another limitation was the small sample size which hindered the study’s power. Moreover, our study was subject to attrition bias as numerous patients were lost to follow up which could have underestimated the recurrence rate.

In conclusion, the hybrid procedure comprises a novel technique for the treatment of hemorrhoids. It theoretically offers a less painful procedure than conventional hemorrhoidectomy with promising results in teams of complication and recurrence rates. Future randomized control trials are needed to validate the efficacy and decreased pain scores of this procedure.

Competing Interest:

The authors have no competing interest

Funding:

No funding was provided for this study

Ethical Approval:

Ethical approval was given for this study by the Institutional Review Board at the American University of Beirut. All Patient Identifiers were removed.

Availability of Data and Transparency:

Data can be obtained by contacting corresponding author Samer Deeba

Contributorship:

Samer Doughan and Samer Deeba did the surgeries and edited the manuscripts. MM, SH, and NJ did the data collection. MM, IM, BH and WE did the literature review and wrote the manuscript.

Acknowledgement:

None

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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.
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No competing interests reported.

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Hybrid Vs Pure Hemorrhoidal Artery Ligation for the Treatment of Hemorrhoids: A Retrospective Study

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