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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 27  |  Issue : 4  |  Page : 311-316

Comparison of rubber band ligation with 3% polidocanol injection sclerotherapy for the treatment of internal haemorrhoids at a Nigerian tertiary hospital


1 Department of Surgery, General Surgery Unit, Lagos University Teaching Hospital, Idi-Araba, Lagos, Nigeria
2 Department of Surgery, General Surgery Unit, Lagos University Teaching Hospital; Department of Surgery, College of Medicine, University of Lagos, Idi-Araba, Lagos, Nigeria
3 Department of Surgery, College of Medicine, University of Lagos, Idi-Araba, Lagos, Nigeria

Date of Submission21-Jul-2020
Date of Decision18-Aug-2020
Date of Acceptance14-Oct-2020
Date of Web Publication04-Nov-2020

Correspondence Address:
Dr. Ayomide Makanjuola
Department of Surgery, General Surgery Unit, Lagos University Teaching Hospital, Idi-Araba, Lagos
Nigeria
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/npmj.npmj_232_20

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  Abstract 


Background: The surgical treatment of internal haemorrhoids is yet to be fully elucidated. Rubber band ligation (RBL) and injection sclerotherapy (IS) are less invasive alternative day-case treatment options with lower morbidity than excisional haemorrhoidectomy. Aims: This was a prospective study that compared the efficacy of RBL with 3% polidocanol IS in the treatment of Grades I to III internal haemorrhoids. Patients and Methods: Sodergren haemorrhoid symptom severity (SHSS) scores of consecutive adult patients with internal haemorrhoids were calculated before and after each of three therapy sessions with RBL and IS. Outcome measures included SHSS scores after treatment, post-procedure pain and complication rates. Data were collated and analysed using SPSS version 23. Results: A total of 74 patients participated in the study with 37 patients in each treatment group. The RBL and IS groups were not statistically different in age (P = 0.506), weight (P = 0.117), height (P = 0.462), BMI (P = 0.153) and gender (P = 0.639). The mean SHSS scores for both groups before therapy (P = 0.876), at 4 weeks (P = 0.669), 8 weeks (P = 0.168) and 12 weeks (P = 0.391) after commencement of therapy were not statistically different. The SHSS scores at 12 weeks after treatment were statistically significantly lower than before treatment in both the groups (P < 0.01). The post-procedure pain score was significantly higher in the RBL than IS group after the first (P < 0.001) and second (P < 0.006) but not after the third therapy session (P = 0.501). The complication rates were low and not significantly different for the RBL and IS groups (5.7% versus 8.1%; P = 0.643). Conclusion: The study concluded that RBL and IS are both effective and safe in the treatment of Grades I, II and III internal haemorrhoids.

Keywords: 3% polidocanol, haemorrhoids, injection sclerotherapy, rubber band ligation, treatment


How to cite this article:
Makanjuola A, Balogun OS, Osinowo AO, Adesanya AA, da Rocha JT. Comparison of rubber band ligation with 3% polidocanol injection sclerotherapy for the treatment of internal haemorrhoids at a Nigerian tertiary hospital. Niger Postgrad Med J 2020;27:311-6

How to cite this URL:
Makanjuola A, Balogun OS, Osinowo AO, Adesanya AA, da Rocha JT. Comparison of rubber band ligation with 3% polidocanol injection sclerotherapy for the treatment of internal haemorrhoids at a Nigerian tertiary hospital. Niger Postgrad Med J [serial online] 2020 [cited 2020 Nov 24];27:311-6. Available from: https://www.npmj.org/text.asp?2020/27/4/311/299908




  Introduction Top


Haemorrhoids, also known as piles, are abnormal enlargements of the cushions of submucosal vascular tissue located within the anal canal, due to malformation of arterial and venous vascular spaces within them.[1],[2],[3],[4] Haemorrhoids are of three anatomic types: internal, external and mixed. Internal haemorrhoids are lined by columnar epithelium and are proximal to the dentate line, while external haemorrhoids are lined by stratified squamous epithelium and are distal to the dentate line. Mixed variety comprises both external and internal haemorrhoids. Goligher described four grades of internal haemorrhoids which has been a useful guide for the selection of appropriate therapy; Grade I as the presence of bleeding per rectum without anal prolapse; Grade II as the presence of anal prolapse with spontaneous reduction; Grade III as the presence of anal prolapse that requires manual reduction and Grade IV as the presence of non-reducible anal prolapse.[5],[6]

Symptomatic haemorrhoids are worrisome to the patients and may impair their overall quality of life.[6] Various techniques for the treatment of haemorrhoids are described in the literature; these include dietary modifications, minimally invasive procedures such as rubber band ligation (RBL), injection sclerotherapy (IS), direct current coagulation and open surgical procedures such as stapled haemorrhoidopexy and haemorrhoidectomy.[7],[8],[9] Efficacy of the aforementioned treatment modalities is based on achieving good symptom control with minimal morbidity and patient satisfaction.[10] Surgical haemorrhoidectomy is considered to be the gold standard therapy,[9],[11],[12] but it has a more pronounced post-operative pain profile and prolonged time to wound healing and resumption of normal activities.[13],[14],[15]

RBL and IS are day-case, office-based procedures which have been shown to have adequate control of symptoms, though repeated treatment sessions are often required to attain therapeutic benefits in RBL and IS.[16],[17],[18],[19],[20] Previous studies have shown variable success rates when these treatment modalities are compared with each other.[21],[22] A few studies in our subregion have documented the efficacies of either of RBL or IS,[7],[23],[24] while some have compared available sclerosants and reported no statistically significant differences in their efficacy.[7] However, to the best of our knowledge, only one of these studies compared the efficacy of RBL and IS among Nigerian patients. This study aims to compare the improvement in symptom severity, post-procedure pain and complication rates with the use of RBL and 3% polidocanol IS among outpatients attending our tertiary hospital.


  Patients and Methods Top


This was a prospective comparative study conducted at a tertiary hospital in Southwest Nigeria between October 2017 and September 2018. Ethical approval (ADM/DCST/HREC/APP/994) for the study was obtained from the Hospital Health Research and Ethics Committee.

The sample size was determined using Fisher's formula N = (Z0.025+ Z0.20) 2 + (P1 [1 − P1] + P2 [1 − P2])/(P1 P2) 2, where Z0.025 is 1.96 (for a two-tailed analysis), Z0.20 is 0.842 at 80% power, P1 is the efficacy of RBL from a previous study[23] and P2 is the efficacy of IS from a previous study.[25] Calculation yielded a sample size of 27 per study group. A further 10% was added to allow for attrition, giving an approximate sample size of 30 per study group.

All patients attending the outpatient clinic with a diagnosis of Goligher Grades I, II and III internal haemorrhoids were included in the study. Excluded from this study were patients with Grade IV haemorrhoids, concomitant anorectal conditions such as fissure-in-ano, fistula-in-ano or anorectal abscesses, patients with previous treatments for haemorrhoids and those that declined to give consent.

Using computer-generated randomisation, consecutive patients who presented to the surgical outpatients with symptomatic Grades I–III internal haemorrhoids were allotted to receive either RBL or IS with 3% polidocanol as a treatment modality. Each patient was counselled for the procedures and written informed consent was obtained. Biodata and anthropological (height, weight and body mass index) and relevant clinical data were obtained from each patient. The severity of symptoms was determined, using the Sodergren haemorrhoid symptom severity (SHSS) score which is a 4-symptom domain questionnaire used in the assessment of the severity of symptoms of haemorrhoids and estimation of response to treatment. SHSS assesses the severity of prolapse, pruritus, pain at rest and pain on bowel motion.[26] The SHSS assigns scores based on the frequency of prolapse, patients who experience prolapse not more than once a week are assigned a score of 0, while those who have prolapse daily are assigned a score of 4. The severity of irritation was scored 0 in patients who did not exhibit such symptom or who complained of only mild irritation; however, patients who complained of moderate or severe irritation were scored 4. The severity of pain or discomfort in the anorectum either at rest or following bowel motion was scored 0 in patients with no pain and in those who complained of mild pain that is described as not bothersome; however, the severity of pain was scored 3 in patients with moderate-to-severe pain or discomfort. A cumulative SHSS was obtained for each patient by adding the individual scores from each symptom domain, which ranged from 0 to 14.

All recruited patients were instructed to undergo bowel preparation consisting of only liquid diet the day before their procedure and to ingest 30 mg of oral bisacodyl the evening before the procedure. On the day of the procedure, all patients were encouraged to move their bowels before admission into the endoscopy suite. Patients were subsequently changed into hospital robes and were placed in the left lateral position with their hips and knees flexed on a couch. An initial digital rectal examination was performed. Patients with faeces in the rectum were requested to defecate before continuation of the procedure. A well-lubricated and well lit proctoscope was inserted into the anus. The dentate line was identified, and the primary haemorrhoidal cushions were identified by the 'face of the clock' position. The Goligher grade was determined using the largest haemorrhoid. A rigid sigmoidoscopy was carried out to exclude concomitant lesions in the rectum and sigmoid colon up to 30 cm from the anal verge.

Rubber band ligation

Two rubber bands (Medix Plus Ltd., Ireland) were applied to the pedicle of each enlarged primary haemorrhoid using the Barron rubber band applicator through a proctoscope [Figure 1] and [Figure 2].
Figure 1: Apparatuses for rubberband ligation. (A) Proctoscope obturator. (B) Proctoscope sleeve. (C) Rubber band applicator. (D) Haemorrhoid tissue grasper. (E) Rubber bands

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Figure 2: Proctoscopic view of internal haemorrhoids after application of rubber band. (A) applied rubber band (B) haemorrhoidal tissue

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Injection sclerotherapy

0.5, 1.0 or 1.5 ml of 3% polidocanol (hydroxy-polyethoxy-dodecane; Samarth Life Sciences PVT Ltd, India; Batch number DA2703) was injected into the submucosa at the pedicle of the haemorrhoids in Grade I, II and III diseases, respectively [Figure 3] and [Figure 4].
Figure 3: Apparatuses for injection sclerotherapy. (A) Proctoscope obturator. (B) Proctoscope sleeve. (C) 2 ml hypoallogenic syringe. (D) Hypodermic needle (23 G). (E) 32 mm 18 G hollow needle. (F) 3% polidocanol sclerosant

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Figure 4: Proctoscopic view of haemorrhoid after injection sclerotherapy. (A) Demonstration of a wheal after injection of the sclerosant

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After the application of therapy to all enlarged primary haemorrhoids, the proctoscope was withdrawn and the patient was admitted into an observation room for at least 1 h before being discharged.

Post-procedure pain was evaluated 30 min after completion of each therapy session using the Wong and Baker[27] pain scoring system which combines a series of images of facial expressions which indicates a progressive worsening discomfort which is a visual analogue system with a corresponding numeric assessment ranging from 0 to 10, where 0 indicates 'no pain' and 10 indicates 'worst pain'.

The patients were instructed to have sitz bath daily for the first 2 days after the procedure and ispaghula husk was prescribed for the same period as an osmotic laxative. Each patient was re-evaluated at 4, 8 and 12 weeks after the initial procedure. During these visits, a repeat proctoscopy was performed to evaluate for the presence of complications such as a non-healing ulcer, bleeding or infections. All patients who remained symptomatic had further treatment using the same modality. At each visit, symptom severity was estimated using the SHSS score. Any patient found not to have an improvement in symptom severity score at the final visit was adjudged to have failed therapy. Patients above the age of 40 years were requested to undergo colonoscopy to exclude other proximal causes of rectal bleeding.

Outcome assessment

The primary outcome measure of this study was to determine the degree of reduction of severity of symptoms by comparing the SHSS score at the onset of therapy with that obtained at the completion of therapy and the severity of immediate post-procedure anal pain and complication rates in both the treatment groups were the secondary outcome measures.

Statistical analysis

All relevant data obtained were analysed using Statistical Package for Social Sciences software for Windows version 23 (IBM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp). Continuous variables were expressed as means and standard deviations. Where the dataset was normally distributed, the means were compared using the Student's t-test, where the dataset was not normally distributed, the Wilcoxon signed-rank test and the Mann–Whitney U-test was used to compare means within a treatment group and between treatment groups respectively.[28] Proportions and percentages were calculated for categorical variables, comparison of categorical variables was done using Pearson's Chi-square test and Fisher's exact test. P < 0.05 was accepted as statistically significant (two-tailed analysis).


  Results Top


A total of 74 patients were recruited for the study with 37 patients in each treatment group. There were 42 (56.8%) males and 32 (43.2%) females with a male-to-female ratio of 1.3:1. The age of the patients ranged from 18 to 84 years with a mean age of 43.8 years. The difference in the mean age of patients in both (RBL and IS) treatment groups was not statistically significant (P = 0.510). Similarly, the difference in the gender distribution (P = 0.639), height (P = 0.462), weight (P = 0.117), BMI (0.153) and grade of haemorrhoids (P = 0.962) were not statistically significant. The distribution of patients by Goligher grade in the study population was as follows, 28.4% of patients had Grade 1 haemorrhoids, while 44.6 and 27.0% had Grades II and III, respectively. These findings are depicted in [Table 1].
Table 1: Age and sex distribution of the study population

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A summary of observed SHSS scores before and after each therapy is shown in [Table 2]. In both the treatment groups, the SHSS score when compared before the onset of therapy was not statistically significant (P = 0.876). After the commencement of therapy, a comparison of the SHSS score between RBL and IS groups at 4 weeks (P = 0.669), 8 weeks (P = 0.168) and 12 weeks (P = 0.391) did not demonstrate statistical significance. Comparison of the SHSS score before the onset of therapy with that obtained after the 12th week therapy was statistically significantly lower in both the RBL (P < 0.001) and IS (P < 0.001) groups [Table 2].
Table 2: Comparison of change in symptom severity scores before and after treatment

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The median pain score was statistically significantly higher in the RBL group compared with the IS group during the first (P < 0.001) and second (P < 0.006) sessions. However, by the third session, the difference in the median pain score no longer demonstrated statistical significance (P < 0.501), as shown in [Table 3].
Table 3: Median pain score of after each therapy session

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Complications of treatment were found in a minority of patients in RBL and IS groups. Of 37 patients in each group, ulceration of the treatment site was observed in 2 (5.7%) patients in the RBL group and 3 (8.1%) patients in the IS group. The difference between the complication rates in both the treatment options was not statistically significant (P = 0.643).


  Discussion Top


The mean age of the patients in this study was 43.8 years with a slight male predilection (male: female = 1.3:1). These findings are similar to those obtained by Akindiose et al.[7] in their study that compared the efficacy of two sclerosants in the treatment of haemorrhoids. A higher mean age of 51.9 years and a higher male preponderance were reported by Ray-Offor and Amadi[29] among a cohort of 121 patients with haemorrhoids diagnosed at endoscopy. Available local studies have reported variations in presentation of grades of internal haemorrhoids. This study excluded patients with Goligher Grade IV haemorrhoids as they are unsuitable for RBL and IS as the mode of treatment. Among the patients who participated in this study, majority (44.6%) had Grade II haemorrhoids. This is similar but lesser in proportion to 90% reported by Misauno et al.[23] in patients who had RBL for haemorrhoids. On the contrary, majority (56.2%) of patients reported by Akindiose et al.[7] had Goligher Grade III haemorrhoids.

Treatment outcome in haemorrhoids is based on resolution of associated symptoms such as pain, recurrent bleeding and prolapse. In the individual treatment groups, this study found that there was a significant reduction in the severity of symptoms when SHSS scores were compared before onset and after the completion of therapy. However, a statistically significant difference in the improvement of symptom severity between the use of RBL and IS as a treatment modality was not found. This is in contrast to the findings from the work done by Abiodun et al.[30] which found that RBL produces a significantly better outcome than IS, though the study focused on Grade II and III haemorrhoids alone. In line with our finding, a meta-analysis by Johanson and Rimm[31] showed that while the success rate of RBL was greater than IS, the difference did not achieve statistical significance. However, another meta-analysis carried out by MacRae and McLeod[32] found RBL to be significantly superior to IS in treatments of Grades I, II and III haemorrhoids.

Post-procedure pain and discomfort are common sequelae of RBL.[21],[33] Local tissue ischaemia and inflammation may be partly responsible for anal pain after RBL. Comparing RBL and IS, a higher and statistically significant post-procedure pain score was recorded in patients of RBL group in this study which was similar to findings of other studies as reported in a meta-analysis by MacRae and McLeod.[32] However, it was observed that this difference in pain score was no longer significant by the third session.

Anal pain and bleeding were the most common complications reported in many series.[32],[34] Very rare but life-threatening complications such as pelvic cellulitis[35] and retroperitoneal abscess[36] have also been reported. The only complication observed in this study was formation of a slowly healing ulcer at the site of the treated haemorrhoid. Overall complication rates following RBL and IS were low in this study, as complications were recorded in <10% of patients in both the treatment groups and the inter-group difference was not statistically significant.

In our study, patients were only followed up for a 3-month period. This implies that recurrence of symptoms beyond the follow-up period of 3 months could not be assessed, this was an important limitation of this study as recurrence rate for RBL and IS varies widely. Jehan et al.[37] reported no recurrence among 50 patients who had RBL after 12 months, while 8% of a similar population who had IS had recurrence of symptoms by 12 months. A systematic review by Cocorullo et al.[38] reported recurrence rates of 2.2%–18% and 2%–29% for RBL and IS, respectively. The methods that have been used to classify haemorrhoids in practice are symptoms based.[6],[26] This limits the ability to quantify the effect of therapy on the physical characteristics such as a change in the size of haemorrhoids, which can be correlated with changes in severity of symptoms.


  Conclusion Top


Our study showed that RBL and IS were equally efficacious in reducing the severity of symptoms of Grades I to III internal haemorrhoids. RBL produced significantly more pain than IS, but both had low complication rates. RBL and IS with 3% polidocanol are therefore recommended as safe and viable first-line treatment options for Grades I to III internal haemorrhoids. Although multiple treatment sessions may be required to achieve symptom resolution, the good post-operative pain profile make them ideal as day case procedures which will save cost and time. However, in cases of treatment failure, excisional haemorrhoidectomy may be required.

Acknowledgement

  • I would like to thank members of staff of the General Surgery Unit of the Lagos University Teaching Hospital and College of Medicine of the University of Lagos, for their assistance and support during the study.
  • I also hereby thank the members of staff of the Endoscopy Suite of the Lagos University Teaching Hospital for their co-operation during the period of the study.


Financial support and sponsorship

This study was financially supported by self-funding.

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
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