|Year : 2020 | Volume
| Issue : 1 | Page : 13-20
Comparative study of endoscopic band ligation versus injection sclerotherapy with 50% dextrose in water, in symptomatic internal haemorrhoids
Adekunle Adedapo Abiodun1, Olusegun Isaac Alatise2, Chukwuma Eze Okereke3, Abudul-Rashid Kayode Adesunkanmi2, Emmanuel Adewale Eletta1, Alexander Gomna1
1 Department of Surgery, Federal Medical Center, Bida, Niger State, Nigeria
2 Department of Surgery, College of Health Science, Obafemi Awolowo University, Ile-Ife, Osun State, Nigeria
3 Department of Surgery, Federal Medical Center, Owo, Ondo State, Nigeria
|Date of Submission||22-Aug-2019|
|Date of Acceptance||21-Nov-2019|
|Date of Web Publication||14-Jan-2020|
Dr. Olusegun Isaac Alatise
Department of Surgery, PMB 5538, OAUTHC, Ile-Ife, Osun State
Source of Support: None, Conflict of Interest: None
Background: Haemorrhoids are common anorectal conditions seen in surgical practice, with various treatment modalities. This study compared the short-term outcome of injection sclerotherapy with 50% dextrose in water and rubber band ligation in the management of second-and third-degree haemorrhoids, in terms of symptoms improvement, complications, recurrence rate, retreatment rate and acceptability. Methodology: This was a prospective comparative study that was carried out in the endoscopic unit of the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, in southwestern Nigeria. Sixty consecutive patients with second- and third-degree haemorrhoids, who consented, were recruited into the study and were randomised into two groups. Group A had endoscopic injection sclerotherapy and Group B had endoscopic rubber band ligation. Results: With regard to anal protrusion, more patients consistently reported either complete (16 [64.4%]) or partial (9 [40.9%]) resolution of symptoms in Group B, compared to Group A which had 7 (28.0%) and 5 (22.7%) cases, respectively (P = 0.03). Resolution of anal bleeding was initially more in Group B than A (22 [95.7%] vs. 17 [77.3%] patients, respectively), in the first 24-h post-treatment; however, within the 1st week, this ratio was reversed (P = 0.07). The retreatment rate for Group A and B was 23.3% and 13.3%, respectively,P = 0.34. More patients in Group B experienced severe pain post-treatment compared to Group A (P = 0.01). Three-month post-treatment, two (11.8%) patients in Group A and one (4.5%) in Group B had recurrence of anal bleeding (P = 0.42). There was no recurrence in anal protrusion in both treatment groups. Conclusion: Endoscopic rubber band ligation had a significantly higher success rate than endoscopic injection sclerotherapy, in terms of resolution of anal protrusion, but with higher pain score.
Keywords: Endoscopic injection sclerotherapy, haemorrhoids, rubber band ligation
|How to cite this article:|
Abiodun AA, Alatise OI, Okereke CE, Adesunkanmi ARK, Eletta EA, Gomna A. Comparative study of endoscopic band ligation versus injection sclerotherapy with 50% dextrose in water, in symptomatic internal haemorrhoids. Niger Postgrad Med J 2020;27:13-20
|How to cite this URL:|
Abiodun AA, Alatise OI, Okereke CE, Adesunkanmi ARK, Eletta EA, Gomna A. Comparative study of endoscopic band ligation versus injection sclerotherapy with 50% dextrose in water, in symptomatic internal haemorrhoids. Niger Postgrad Med J [serial online] 2020 [cited 2020 Apr 6];27:13-20. Available from: http://www.npmj.org/text.asp?2020/27/1/13/275806
| Introduction|| |
Haemorrhoids are the clinical manifestation of the downward disruption of normal functional structures known as the anal cushions. The condition is considered one of the most frequent diseases of the anal region as it accounts for nearly 50% of proctological visits in a colorectal unit. It is also estimated that about half of the population would have haemorrhoids by the age of 50 years. Haemorrhoids can occur at any age, and they affect both men and women; the exact incidence in developing countries is unknown, but the disease is being more frequently encountered in our environment, perhaps due to westernised life style and diet.
The interest in management of haemorrhoids started from antiquity, as symptomatic haemorrhoidal disease has plagued mankind in historical references dating back to at least 4000 years., Numerous modalities and techniques have been developed to treat symptomatic haemorrhoids ranging from simple dietary and life style modification, through a number of non-operative procedures, to different techniques of excision of diseased anal cushions. These vast number of treatment options suggest that none is close to perfection. Non-operative management is considered the treatment of choice for patients with symptoms (anal bleeding or pain) and Grades 1, 2 and 3 internal haemorrhoids., These methods aim at tissue fixation achieved by sclerotherapy, cryotherapy, photocoagulation, laser or fixation with tissue excision using rubber band ligation. While many non-operative procedures are effective in controlling symptoms from the patients' perspective, they all share the common problem of recurrence. Although surgical haemorrhoidectomy is more definitive in symptom control, it has a reputation for being a painful procedure for a relatively benign disorder. In view of this, most patients decline surgical excision of haemorrhoids due to the anticipated pain and the widely believed myth that it is associated with impotency in men. Nowadays, over 90.0% of haemorrhoids are manageable by non-operative methods and only <10.0% are subjected to haemorrhoidectomy.
Injection sclerotherapy and rubber band ligation are two commonly used non-operative methods with low recurrence. The injected sclerosant obliterates the haemorrhoids' vascularity, inducing inflammation and fibrosis which fixes the haemorrhoids to the surrounding tissue and prevents prolapse., A prospective study by Khoury et al. demonstrated that 89.9% of patients with Grades 1 and 2 haemorrhoids had significant improvement in their symptoms with 5% phenol in almond oil.
Rubber band ligation uses the placement of a constricting band around redundant haemorrhoidal mucosa, producing ischemia. As the ischemic mucosa necroses, the tissue sloughs, forming a small ulcer, which on healing, fixes the remaining mucosal lining to the underlying wall of the anal canal, preventing prolapse. Misauno et al., showed 97.5% of patients were cured of their symptoms using this method.
Studies have compared injection sclerotherapy with 5% phenol in almond oil and rubber band ligation in the treatment of haemorrhoids.,, Laghari Zameer et al. showed that rubber band ligation relieved symptoms in 94.5% of patients, while injection sclerotherapy relieved symptoms in 79.0% of patients. We are not aware of any previous study comparing these two modalities of treatment in our environment. This may be due to the unavailability of 5% phenol in almond oil in our environment.
Khazaie et al., showed that 50% glucose water could be as efficient as phenol in olive oil solution when comparing the two types of sclerosing agents in the treatment of haemorrhoids. Akindiose et al., also reported similar findings when the two sclerosants were compared. Preliminary report by Alatise et al., also showed a good sclerosing effect of 50% dextrose in water as over 90.0% of their patients reported significant improvement in their symptoms.
This study was aimed at prospectively evaluating the short term outcome of rubber band ligation and injection sclerotherapy with 50% dextrose in water, in a randomised controlled trial, for the treatment of second and third degree haemorrhoids.
| Methodology|| |
This was a randomised, prospective comparative study, carried out in the endoscopy unit of the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, in southwestern Nigeria, between March 2015 and February 2016. Ethical approval was obtained from the institutional Ethical and Research Committee, with the protocol number ERC/2014/09/03.
Adult males and females aged 18–75 years with second-or third-degree haemorrhoids, who consented to treatment with either injection sclerotherapy or rubber band ligation, were recruited into the study. Grade 2 haemorrhoids had anal protrusion that spontaneously regressed after stooling while Grade 3 haemorrhoids had to be manually reduced after stooling. Diagnosis was made from combination of clinical information and proctoscopic evaluation, while colonoscopy was done, when indicated, to rule out the possibility of other lesions. Excluded from the study were Patients with other anorectal lesions such as fissure-in-ano, fistula-in-ano, anorectal neoplasia and those who had previous anorectal surgery, as well as patients with immunosuppression due to diabetes mellitus, retroviral disease or on any form of immunosuppressant therapy and those with bleeding disorders or on anticoagulants.
Sample size and sampling method
The sample size was estimated using the sample size formula for experimental studies by Sathian et al.
Zβ is 0.84 (from Z table), at 80% power.
Zα/2 is 1.96 (from Z table), at 95% confidence level.
P1 and P2 are 70% and 98%, respectively (proportions of patients treated with injection sclerotherapy and rubber band ligation, respectively, that showed desired therapeutic effect).
This gave the minimum sample size to be 24 in each group; and with 10% expected attrition rate added, it became 27 in each group. The total minimum sample size was therefore 54 (27 patients in each group).
The patients recruited were randomised into two groups, by simple randomisation, using sixty ballot papers labelled with either of the treatment options, thirty in each group. Each pre-labelled paper was sealed in an opaque envelope, and the envelopes were mixed together and shuffled. Each of the recruited patients picked a sealed envelope at random and the procedure selected by each patient was carried out on him or her.
Pre-procedural assessment with haemoglobin estimation, urinalysis and proctoscopy with or without colonoscopy were done on all the patients. The patients who were older than 50 years had colonoscopy done, to exclude other sources of bleeding in them; likewise, patients who had alarming symptoms such as tenesmus, weight loss and anorexia, to rule out the possibility of colorectal malignancy.
Group A: Injection sclerotherapy with 50% dextrose in water
The patient was placed in left lateral or knee elbow position, and topical anorectal administration of anaesthetic gel containing 2% lignocaine hydrochloride was done. Proctoscopic examination was done to identify the haemorrhoidal swellings, after which 3–5 ml of 50% dextrose water was injected into the haemorrhoidal swelling about 1 cm above the dentate line using a 23-G needle. All haemorrhoidal swellings seen in each patient were injected at one sitting.
Group B: Rubber band ligation
The procedure was done using a reusable Barron rubber band apparatus. The patient was placed in the left lateral or knee elbow position, and topical anorectal anaesthetic gel containing 2% lignocaine hydrochloride was similarly administered. Proctoscopic examination was done to identify the haemorrhoidal swellings, after which haemorrhoidal tissue, 1–2 cm above the dentate line, was grasped with a haemorrhoidal grasping forceps and pulled into the barrel of the Barron's banding apparatus and a small rubber band slipped over it. Patients with one or two haemorrhoidal tissues had all the tissues banded at one sitting while those with three tissues had two banded at first sitting and the third tissue banded 2 weeks later to complete one session of treatment.
After the procedure, each patient was observed in the endoscopic room for 2 h by a blinded senior registrar in order to detect any early complications, such as haemorrhage and pain, before discharge. Post-operative pain was assessed immediately after the procedure using a numeric pain rating scale (NPRS) in which 0 represents no pain and 10 represents the worst pain imaginable. Oral 50 mg diclofenac sodium was administered twice daily to all patients who had moderate to severe pain, immediately after the post-procedural pain assessment was done. This was repeated by the patients at home until their pain subsided. Another session of treatment was performed at 1 month interval for the patients who had persistent symptoms. The patients were followed up at the outpatient clinic at 1-week, 2-week, 1-month, then at 3-month post-procedure, during which parameters such as recurrence of bleeding, anal protrusion anal pain, anal discharge and pruritus ani were all assessed. Routine digital rectal and proctoscopic examination was done at 1 and 3 months, as part of the patients' assessment.
Assessment of outcome
Post-procedural complications were assessed using a structured questionnaire for the patient. Pain perception was assessed using NPRS at 2 h, 1 week and 2 weeks after the procedure, and this was graded as scores of 1–3 for mild pain, 4–6 for moderate pain and 7–10 for severe pain.
Resolution of anal protrusion was assessed using a graded response into complete resolution (if there was no more anal protrusion), partial resolution (if Grade 3 disease became Grade 2 for example) and no change (if there was no response at all). The treatment efficacy was defined in terms of complete or partial resolution of anal protrusion. Resolution of other haemorrhoidal symptoms was assessed using a structured questionnaire, and the treatment efficacy was defined in terms of the presence or absence of those symptoms. Patients' satisfaction was assessed using a structured questionnaire with a scaled or graded response, and acceptability was assessed using a structured questionnaire with a 'yes' or 'no' response. Assessment was done by blinded senior registrars in general surgery unit.
Data collected were analysed by computer analysis using the IBM SPSS Statistics for Windows, version 22. 0 Armonk, NY: IBM Corp. The frequency distribution of the variables was presented in tables and charts. The mean and standard deviation of the age were determined, as well as the median duration of symptoms. The Student's t-test was used to determine the statistical significance, and the Chi-square was used to test the distribution of demographic and clinical variables among the two groups. The Chi-square was also used to test the resolution of haemorrhoidal symptoms with significance level taken at 95% confidence interval (P < 0.05).
| Results|| |
A total of sixty patients were recruited for the study and were randomised equally into the endoscopic injection sclerotherapy (Group A) and rubber band ligation (Group B). Their ages ranged from 21 to 72 years with mean age of 42.8 ± 13.3 years. In Group A, the mean age was 43.4 ± 14.3 years while in Group B, it was 42.1 ± 12.3 years. There was no significant difference in the mean age of the two groups (P = 0.71). The study population comprised 46 males (76.7%) and 14 females (23.3%), while Groups A and B had 22 and 24 males, respectively. There was no significant difference between the two study groups in terms of gender distribution, as shown in [Table 1] (P = 0.55).
The grade of haemorrhoids and the number of haemorrhoidal tissue per patient is as shown in [Table 2]. There was no significant difference in the two study groups, in terms of the grade of the haemorrhoids (P = 0.20); similarly, the number of haemorrhoids per patient was not significantly different between the two groups (P = 0.13).
The main indications for treatment were anal protrusion in 47 (40.5%) and anal bleeding in 45 (38.8%) patients. The distribution of the other indications for treatment is shown in [Figure 1]. None of the factors that were an indication for seeking treatment was found to be significantly different between the two study groups.
|Figure 1: Distributions of haemorrhoidal symptoms between the two groups. EIS: Endoscopic injection sclerotherapy, EBL: Endoscopic rubber band ligation|
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The response of the two treatment methods was assessed in terms of resolution of anal protrusion, bleeding and pain. With regard to anal protrusion, more patients consistently reported either complete or partial resolution of the anal protrusion in the endoscopic rubber band ligation group, compared to the endoscopic injection sclerotherapy group [Figure 2]. More patients in the injection sclerotherapy group reported no changes in their anal protrusion. These differences in treatment outcome were statistically significant (P = 0.03).
|Figure 2: Assessment of resolution of anal protrusion. EIS: Endoscopic injection sclerotherapy, EBL: Endoscopic rubber band ligation|
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In terms of resolution of anal bleeding, more patients who had endoscopic rubber band ligation initially reported resolution of bleeding, in the first 24-h post-treatment, compared to those that had endoscopic injection sclerotherapy (22 [95.7%] patients versus 17 [77.3%] patients, respectively); however, within the 1st week post-treatment, this ratio was reversed and the higher ratio of resolved anal bleeding, now in the endoscopic injection sclerotherapy group, was sustained till the 3rd month post-treatment [Figure 3]. These differences were, however, not statistically significant (P = 0.07).
|Figure 3: Assessment of resolution of anal bleeding. EIS: Endoscopic injection sclerotherapy, EBL: Endoscopic rubber band ligation|
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A higher number of the patients in the endoscopic rubber band ligation group presented with anal pain; and post-therapy, complete resolution of this anal pain took longer than in the endoscopic injection sclerotherapy group [Figure 4]. These differences in the duration of resolution of anal pain in the two treatment groups were, again, not significant (P = 0.35).
|Figure 4: Assessment of resolution of anal pain. EIS: Endoscopic injection sclerotherapy, EBL: Endoscopic rubber band ligation|
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During observation for early complications within 2 h of procedure in the endoscopic room, more patients in the endoscopic rubber band ligation group complained of post-procedural pain, compared to the endoscopic injection sclerotherapy group (13 [43.3%] vs. 10 [30.0%] patients, respectively). This immediate post-procedural pain was not significant between the two groups (P = 0.29). When the intensity of the pain was subanalysed [Table 3], a greater number of the patients in the endoscopic rubber band ligation group reported higher moderate and severe pain, compared to the endoscopic injection sclerotherapy group. On statistical analysis, this difference was significant for severe pain (P = 0.01). Oral diclofenac sodium relieved the moderate or severe pain in both groups. No complication in terms of fever and perineal sepsis was recorded in the two treatment groups.
After 3 months of follow-up, none of the patients who had initial resolution of anal protrusion had a recurrence in both treatment groups. Whereas 2 (11.8%) patients in the injection sclerotherapy group and 1 (4.5%) in the endoscopic rubber band group had a recurrence of bleed after the initial resolution of anal bleeding [Table 4], this was not significant (P = 0.42). No patient with anal discharge, pain or pruritus had recurrence of their symptoms. With regards to re-treatment, seven patients treated with injection sclerotherapy and four patients treated with endoscopic rubber banding required another session of treatment, giving a retreatment rate of 23.3% and 13.3%, respectively. This was also not statistically significant (P = 0.34).
|Table 4: Assessment of patients' recurrence of anal bleeding at 3 months of follow up|
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Assessment of patient satisfaction and acceptance of the respective treatment options was similar in both groups ([P = 0.12]; [P = 0.17], respectively). Majority of the patients were satisfied and accepted the treatment in either group [Table 5] and [Table 6] and were willing to recommend the treatment regimen to others.
| Discussion|| |
This study was conducted to compare endoscopic injection sclerotherapy and rubber band ligation in the treatment of patients with internal haemorrhoids. All the patients in the study presented with anal protrusion and bleeding, therefore, resolution of the anal protrusion and bleeding were considered the most appropriate outcome measures to assess the efficacy of treatment. These symptoms could be easily assessed with much objectivity as being present or absent.
In terms of efficacy and immediate resolution of anal bleeding, there was a trend toward better results with rubber band ligation than injection sclerotherapy though this was not statistically significant; the therapeutic efficacy for endoscopic injection sclerotherapy for anal bleeding was 77.3% while for endoscopic rubber band ligation was 95.7%. In a prospective randomised study by Awad et al., comparing endoscopic band ligation with injection sclerotherapy for bleeding internal haemorrhoids in patients with liver cirrhosis, both techniques were found to be highly effective in the control of bleeding from the internal haemorrhoids, with success rate of 90.0% with rubber band ligation and 87.3% with injection sclerotherapy. This is also similar to the findings by Ghulam et al., in a multicentre prospective randomised study where 100 patients with second degree haemorrhoids were treated using rubber band ligation and 5% phenol in olive oil; they recorded complete resolution of bleeding in 95.6% and 75.6% of cases, respectively, at the end of 6 months of follow-up. The differences in the resolution of anal bleeding in these studies were not statistically significant.
Our study also showed that the degree of resolution of anal protrusion at the end of 3 months of follow up was higher with endoscopic rubber band ligation. This significantly higher proportion of patients with resolution of anal protrusion following band ligation demonstrates that endoscopic rubber band ligation is a more efficacious therapy in the presence of anal protrusion. This is also similar to what Ghulam et al., obtained in their study in terms of the resolution of anal protrusion. They found that 96.0% of patients who had rubber band ligation had improvement of their anal protrusion, compared to 64.0% in the injection sclerotherapy group. Laghari Zameer et al., also showed that rubber band ligation relieved symptomatic anal protrusion in 94.5% of their patients, while injection sclerotherapy relieved symptoms in only 79.0%. A prospective study by Khoury et al., demonstrated that 89.9% of patients with haemorrhoids had significant improvement in their symptoms with injection sclerotherapy using 5% phenol in almond oil, whereas Misauno et al., showed that 97.5% of patients were cured of their symptoms using rubber band ligation.
One of the major complications of various treatment modalities of haemorrhoids is pain. The occurrence of immediate post procedural pain was statistically not significant between the two groups. In terms of severity of pain, however, more patients in the endoscopic rubber band ligation group had higher pain scores which necessitated the use of oral diclofenac sodium to relieve their pain. This was similar to the finding by Ghulam et al., who reported in their study that patients experienced higher pain with rubber band ligation when compared with injection sclerotherapy. This finding however contrasted with what Awad et al., reported, in which pain score and need for analgesia were significantly higher with endoscopic injection sclerotherapy compared to endoscopic rubber band ligation. The possible reason for this finding was provided by Tchirkow et al., who postulated that the post-banding pain may be due to a band being placed within the receptive field of an aberrant somatic cutaneous nerve or a band into which fibres of the internal sphincter are being drawn. Proper technique of ligation, to avoid pain, dictates that rubber bands be placed well above the dentate line on the rectal mucosa. In our study, however, all the bands were properly placed. Another possible explanation for the higher pain experienced by patients in the rubber band ligation group may be due to pressure sensation caused by oedema produced by the rubber band or the foreign body sensation as suggested by Kotzampassi.
Many non-operative procedures are effective in controlling symptoms from the patients' perspective; however, they all share the common problem of recurrence. Rubber band ligation has the lowest recurrence rate at 12 months compared to sclerotherapy and other minimal invasive procedures. According to Jehan et al., at 12 month of follow-up, 92.0% of patients remained symptom free following injection sclerotherapy while all patients who had rubber band ligation were symptoms free.However, Awad et al., reported that the recurrence rate was 20% in both groups at the end of 6-month follow-up. After 3 months of follow-up in our study, none of the patient with complete resolution of anal protrusion had a recurrence, while 2 (11.8%) patients who had endoscopic injection sclerotherapy and 1 (4.5%) patient who had endoscopic rubber ligation had a recurrence of anal bleeding after the initial resolution of symptoms.
Patients that do not have improvement of their symptoms usually have another session (retreatment) after a month. The retreatment rate from this study for the endoscopic injection sclerotherapy group was 23.3%, while it was 13.3% for the endoscopic rubber ligation group. This was similar to what Laghari Zameer et al., reported in their study where 29.7% of patients who had rubber band ligation had two sessions, compared to 44.2% of patients in the injection sclerotherapy group who also had two sessions. Similarly Jehan et al., showed that only 56% of patients were symptoms free after 4–6 weeks with single session of injection sclerotherapy, 32% required additional second session at 8 weeks and 12% required third session at 12 weeks due to persistence of symptoms. This was comparatively <88.0% of patients in their study who were symptom free within 4 weeks after a single session of rubber band ligation, with only 12% requiring a second session at 10 weeks to become symptom free. The need for retreatment has been found in some studies to be related to the grade of the haemorrhoid: higher in Grade III than Grade II. There was no significant difference, in terms of the grade of the haemorrhoids and the number of haemorrhoidal tissue per patient, in the two intervention groups of our study however.
While resolution of symptoms appears to be the most important measure of success, the perception of the patient with regards to acceptability and satisfaction are very important in promoting a particular practice. These two methods of treatment were well accepted by the patients. A satisfied patient who has accepted a particular method of treatment will gladly recommend the same treatment to other sufferers.
| Conclusion|| |
Endoscopic rubber band ligation had a significantly higher success rate and required fewer sessions than endoscopic injection sclerotherapy to relieve anal protrusions and possibly anal bleeding. The complication rates of both procedures were few and similar, but more patients had severe pain with endoscopic rubber band ligation and this difference was significant. The recurrence rate of haemorrhoidal symptoms after 3 months of follow-up was low in both groups. There is, however, need for more patients, with an extended period of follow-up, to further validate these results.
This study was not without some limitation. A follow up period of 3 months was used to assess the recurrence rate, to keep within the time allotted for the study. A longer period of follow-up could possibly be more informative.
Based on this study, we recommended that both procedures should be promoted in the treatment of haemorrhoids in our environment because of their effectiveness and low complication rates. For patient whose primary concern is anal protrusion, endoscopic rubber band ligation is recommended because it is associated with a significantly higher rate of resolution of anal protrusion, compared to endoscopic injection sclerotherapy. When the primary concern is anal bleeding, however, endoscopic injection sclerotherapy, having being demonstrated to be less painful, may be recommended; since the clinical outcomes of resolution of bleeding in the two groups were not significantly different.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]