Complication of Rubber Band Ligation in Second and Third Degree Haemorrhoids

Haemorrhoids or piles are symptomatic anal cushions [1]. Degree of haemorrhoids can be classified as 1^st degree (only bleed), 2^nd degree (prolapse but reduce automatically), 3^rd degree (prolapse and requires manual reduction) and 4^th degree (permanent prolapsed). The approach in treatment of haemorrhoids has significantly changed in the past few decades [2].

Haemorrhoids can be managed either conservatively by regular sitz bath, dietary modifications and medications etc., or by minimal invasive procedures like RBL, sclerotherapy, cryotherapy, diathermy using bipolar, coagulation by Infrared rays or Laser, dilatation of anal region, ultroid and treatment with diode laser [3].

RBL is the most common non surgical and outpatient modality performed. As it is a safe, effective and easier to execute, it is being advised as an OPD procedure [3]. RBL was first described by Blaisdell in 1954. It was popularised by Barron in 1963 and now considered to be the most popular outpatient treatment for symptomatic internal haemorrhoids. RBL has low complication and is effective when compared to operative procedure. Recurrent internal haemorrhoids are also treated using RBL [4].

RBL is the most commonly used feasible, minimally invasive procedure, representing a balance between efficacy, pain and potential of complications [5] with success rate from 69 percent to 97 percent irrespective of the problems that are associated with surgical procedures [6]. The minor complications of RBL commonly consists of blood loss, pain, vasovagal reflex, slipping of the bands, urinary retention and long standing ulcers (vertical) [7]. Marshman D et al., found that the complication rate of RBL increases when multiple ligations are performed in one session [8]. The life threatening complication of RBL is pelvic sepsis.

At present there are two scenarios in context to RBL; one scenario shows minor complications whereas the other shows life threatening complications. Hence, the present study was conducted to compare both major as well as minor complications of RBL in Indian population having second and third degree haemorrhoids simultaneously.

Materials and Methods

This prospective interventional study was conducted after the approval of the Ethical Committee (DMIMS (DU)/IEC/2017-18/6646), in the Department of Surgery, Jawaharlal Nehru Medical College, Deemed University, Sawangi (Meghe) from September 2017 to July 2019. Written consents were obtained from all the patients.

Sample Size Calculation [9]

Where,

P=overall success rate (88.6%);

L=Allowable error (11.5% of p=9.959);

q=100-p (13.4)

The sample size was 50. All patients of 2^nd and 3^rd degree internal haemorrhoids were included in the study. Patients with 1^st and 4^th degree haemorrhoids, thrombosed haemorrhoids, inflammatory bowel disease, blood dyscriasis, haemorrhoids with rectal prolapsed and infected haemorrhoids were excluded.

Patients presenting with complaint of bleeding per rectum were thoroughly evaluated by complete physical examination, including per rectal examination and proctoscopy. The possible complications were explained and RBL was performed after taking informed consent. The base of the haemorrhoids was clearly visualised and band applied above the dentate line.

The details of procedure included proctoscopy to which pen torch was attached to provide illumination thereby displaying haemorrhoids. Initially, the instrument was washed and treated with 2% gluteraldehyde solution for 20 minutes before using in each patient [10]. Each haemorrhoid trunk was then caught above the dentate line with a pre-loaded baron band ligator.

After procedure, patient was kept under observation for 6 hours for complaint of pain, bleeding and other complications like vasovagal reflex, urinary retention, slippage of band. Patient was also observed for pelvic infection. Patient was followed-up till 6 weeks for success and recurrence [9]. Pain was measured using Visual Analogue Scale (VAS). The minimum score was 0 and maximum score 6 in the study- 0: denoted no pain corresponding to VAS of 0 mm; 2-4: Mild pain corresponding to VAS of 1-40 mm; 6: Moderate pain corresponding to VAS of 41-60 mm; 8: Severe pain corresponding to VAS of 61-80 mm; and 10: Very severe Pain corresponding to VAS of 81-100 mm. Patients with severe and very severe pain were not taken into the study.

Success in a patient was defined as patient being completely asymptomatic for 6 weeks after the procedure with no evidence of haemorrhoids noted on proctoscopy whereas, recurrence was defined as symptomatic patients with evidence of haemorrhoids on proctoscopy 6 weeks after rubber band application [9].

The event of bleeding was controlled by using appropriate medicines Tranexamic acid 10 mg/kg body weight. Pain was controlled with appropriate medicines like Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like Paracetamol 500 mg BD.

Statistical Analysis

Statistical analysis was done by using descriptive and inferential statistics through chi-square test. SPSS software 24.0 version and Graph Pad Prism 7.0 version was used in the analysis. Level of significance was considered as less than 0.05.

Results

Maximum number of patients was seen between the age group of 41 to 50 years [Table/Fig-1]. Out of 50 patients 35 were males and 15 were females. Male:Female ratio was 2.3:1. Out of the 50 patients, 84% had 2^nd degree haemorrhoids and 16% had 3^rd degree haemorrhoids.

[Table/Fig-1]:

Age wise distribution of patients.

Age group (Year)	No of patients	Percentage
≤20	5	10
21-30	6	12
31-40	9	18
41-50	12	24
51-60	8	16
61-70	6	12
71-80	3	6
>80	1	2
Total	50	100
Mean±SD	45.50±17.71(16-86 years)

SD: Standard deviation

Complications in Patients after RBL

a. Post RBL Bleeding

Out of 50 patients, bleeding was present in three patients at 6 weeks post-procedure. Out of the three patients, one (2%) patient had 2^nd degree haemorrhoids and two (4%) patients had 3^rd degree haemorrhoids (χ²=6.09 and p-value=0.01).

b. Pain after RBL

Pain after RBL was assessed by Visual Analogue Scale at 6 weeks post-procedure and given an appropriate scoring. The minimum score was 0 and maximum score 6 [Table/Fig-2]. Post RBL the patients experience either no pain, mild pain or moderate pain.

[Table/Fig-2]:

Pain score according to degree of haemorrhoids.

Pain score	Degree of haemorrhoids		χ2-value	p-value
	2nd degree	3rd degree
0	18 (36%)	1 (2%)	10.52	0.014
2	1 (2%)	1 (2%)
4	16 (32%)	1 (2%)
6	7 (14%)	5 (10%)
Total	42 (84%)	8 (16%)

Other Complications after RBL

The most common complication seen was urinary retention and the incidence was same in patients with both 2^nd and 3^rd degree haemorrhoids. Out of 50 patients, none of the patients suffered from any pelvic infection [Table/Fig-3].

[Table/Fig-3]:

Other complications according to degree of haemorrhoids.

Other complications		Degree of haemorrhoids		χ2-value	p-value
	2nd degree	3rd degree
Urinary retention	Present	2 (4%)	2 (4%)	3.73	0.053
	Absent	40 (80%)	6 (12%)
Slippage of band	Present	0 (0%)	1 (2%)	-	-
	Absent	42 (84%)	7 (14%)
Vasovagal reflex	Present	0 (0%)	0 (0%)	-	-
	Absent	42 (84%)	8 (16%)

NS: Non-significant

Treatment Modalities to Manage Complications

Most of the complications post RBL were managed conservatively, either by NSAID’s like Paracetamol 500 mg BD, Tranexamic acid 10 mg/kg body weight given twice daily for 3 days and then SOS or by temporary Foley’s catheterisation. Re-Banding was required only in 2% of the patients [Table/Fig-4].

[Table/Fig-4]:

Treatment modalities to manage complications.

Treatment modalities		Number of patients
	Medical Management for bleeding (Tranexamic acid 10 mg/kg body weight given twice daily for 3 days and then SOS)		Required	3 (6%)
Not required		47 (94%)
Pain killer (NSAIDS: Paracetamol 500 mg BD)	Present	11 (22%)
	Absent	39(78%)
Catheterisation for urinary retention	Present	4 (8%)
	Absent	46 (92%)
Re-banding	Present	1 (2%)
	Absent	49 (98%)

Outcome

Urinary retention is the inability to completely or partially empty the bladder and was recorded in 1^st week after procedure. Vasovagal reflex is defined as sudden drop in the heart rate and blood pressure leading to fainting and was observed during the procedure. Slippage of band was assessed at 6 weeks post-procedure. Out of 50 patients, success rate of RBL was 94% (47 patients) and recurrence rate after RBL was 6% (3 patients), when followed-up for a period of 6 weeks.

Discussion

Various post RBL complication encountered by the patients in 2^nd degree and 3^rd degree haemorrhoids were studied. The most common complication experienced by the study population was pain (62%) which is consistent with many other studies as mentioned in [Table/Fig-5] [5,14-18]. Urinary retention (8%) is the second most common co complication experienced by the study population as shown in [Table/Fig-5] [9,18]. There were no cases showing life threatening complications like vasovagal reflex [3,19] and pelvic infections [3] in the study as well as some other studies mentioned in [Table/Fig-5] [2,3,5,9,11-20].

[Table/Fig-5]:

Complications of Rubber Band Ligation seen in various studies [2,3,5,9,11-20].

	Total patients	Post RBL bleed	Post RBL pain	Urinary retention	Slippage of band	Vasovagal reflex	Pelvic infection
Present study	50	6%	62%	8%	2%	0%	0%
El Nakeeb AM et al., [11]	750	4.13%	-	-	-	-	-
Aram FO [3]	890	-	-	-	-	0.6%	0.1%
Forlini A et al., [12]	206	2.4%	-	-	-	-	-
Hadi A et al., [13]	105	3.8%	-	-	-	-	-
Nikam V et al., [9]	60	16.6%	-	6.7%	-	-	-
Azizi R et al., [14]	60	-	62%	-	-	-	-
Watson NFS et al., [15]	183	-	90%	-	-	-	-
Hardwick RH and Durdey P, [16]	52	-	81%	-	-	-	-
Kotzampassi K [5]	87	-	31.2%	-	-	-	-
Kumar N et al., [17]	98	-	24.5%	-	-	-	-
Khaliq T et al., [18]	56	-	13%	-	-	-	-
Chandra B et al., [19]	100	-	-	5%	-	0%	-
Ratan R and Rao PP, [2]	100	-	-	-	0%	-	-
Bat L et al., [20]	512	-	-	-	1%	-	-

Like many other studies [2,20], the present study also showed a higher success rate (94%) of RBL procedure for 2^nd and 3^rd degree haemorrhoids [Table/Fig-2] and lower recurrence (6%) of complications of RBL procedure for 2^nd and 3^rd degree haemorrhoids [Table/Fig-6] [2,20].

[Table/Fig-6]:

Comparison of success rate of Rubber band ligation and recurrence of complications of Rubber band ligation [2,20].

Limitation(s)

The follow-up period in this study was 6 weeks. The study was a single centre study and the sample size was less, hence might have an impact on the outcome of study.

Conclusion(s)

Post RBL bleeding was more in third degree haemorrhoids. The success rate in this study was 94% at six weeks. To conclude, RBL is safe, outpatient procedure in second and third degree haemorrhoids with low rate of recurrence.

SD: Standard deviation

[1]. Williams NS, Connell PR, McCaskie AW, Bailey and Love’s Short Practice of Surgery 2018 27th EditionTaylor and Francis Group:1355  [Google Scholar]

[2]. Ratan R, Rao PP, Rubber band ligation in early stage hemorrhoids: Outcome & efficacy in today’s era International J of Healthcare and Biomedical Research 2018 6(2):66-72.  [Google Scholar]

[3]. Aram FO, Rubber band ligation for hemorrhoids: An office experience Indian J Surg 2016 78(4):271-74.10.1007/s12262-015-1353-127574343  [Google Scholar]  [CrossRef]  [PubMed]

[4]. Lee HH, Spencer RJ, Beart RWJr, Multiple hemorrhoidal bandings in a single session Dis Colon Rectum 1994 37(1):37-41.10.1007/BF020472128287745  [Google Scholar]  [CrossRef]  [PubMed]

[5]. Kotzampassi K, Rubber band ligation of haemorrhoids- An Office Procedure Annals of Gastroenterology 2003 16(2):159-61.  [Google Scholar]

[6]. Iyer VS, Shrier I, Gordon PH, Long-Term outcome of rubber band ligation for symptomatic primary and recurrent internal haemorrhoids Dis Colon Rectum 2004 47(8):1364-70.10.1007/s10350-004-0591-215484351  [Google Scholar]  [CrossRef]  [PubMed]

[7]. Albuquerque A, Rubber band ligation of hemorrhoids: A guide for complications World J Gastrointest Surg 2016 8(9):614-20.10.4240/wjgs.v8.i9.61427721924  [Google Scholar]  [CrossRef]  [PubMed]

[8]. Marshman D, Huber PJ Jr, Timmerman W, Simonton CT, Odom FC, Kaplan ER, Hemorrhoidal ligation. A review of efficacy Dis Colon Rectum 1989 32(5):369-71.10.1007/BF025636832714125  [Google Scholar]  [CrossRef]  [PubMed]

[9]. Nikam V, Deshpande A, Chandorkar I, Sahoo S, A prospective study of efficacy and safety of rubber band ligation in the treatment of Grade II and III haemorrhoids- A western Indian experience J Coloproctol (RIO J) 2018 38(3):189-93.10.1016/j.jcol.2018.03.006  [Google Scholar]  [CrossRef]

[10]. Cowan RE, Cleaning and disinfection of equipment for gastrointestinal endoscopy. Report of a working party of the British Society of Gastroenterology Endoscopy Committee Gut 1998 42(4):585-93.10.1136/gut.42.4.585  [Google Scholar]  [CrossRef]

[11]. El Nakeeb AM, Fikry AA, Omar WH, Fouda EM, Metwally TAE, Ghazy HE, Rubber band ligation for 750 cases of symptomatic hemorrhoids out of 2200 cases World J Gastroenterol 2008 14(42):6525-30.10.3748/wjg.14.652519030206  [Google Scholar]  [CrossRef]  [PubMed]

[12]. Forlini A, Manzelli A, Quaresima S, Forlini M, Long-term result after rubber band ligation for haemorrhoids Int J Colorectal Dis 2009 24(9):1007-10.10.1007/s00384-009-0698-y19387663  [Google Scholar]  [CrossRef]  [PubMed]

[13]. Hadi A, Aman Z, Anwar F, khan M, Iqbal Z, Experience of rubber band ligation for haemorrhoidal disease Pak J Med Res 2011 50(3):104-07.  [Google Scholar]

[14]. Azizi R, Rabani-Karizi B, Taghipour MA, Comparision between Ultroid and rubber band ligation in treatment of internal haemorrhoids Acta Med Iran 2010 48(6):389-93.  [Google Scholar]

[15]. Watson NFS, Loptrott S, Maxwell-Armstrong CA, A prospective audit of early pain and patient satisfaction following out-patient band ligation of haemorrhoids Ann R Coll Surg Engl 2006 88(3):275-79.10.1308/003588406X9864916719998  [Google Scholar]  [CrossRef]  [PubMed]

[16]. Hardwick RH, Durdey P, Should rubber band ligation of haemorrhoids be performed at the initial outpatient visit? Ann R Coll Surg Engl 1994 76(3):185-87.  [Google Scholar]

[17]. Kumar N, Paulvannan S, Billings PJ, Rubber band ligation of haemorrhoids in the out-patient clinic Ann R Coll Surg Engl 2002 84(3):172-74.  [Google Scholar]

[18]. Khaliq T, Shah SA, Mehboob A, Outcome of rubber band ligation of haemorrhoids using suction ligator J Ayub Med Coll Abbottabad 2004 16(4):34-37.  [Google Scholar]

[19]. Chandra B, Karthik KS, Kumari S, Suman RK, An evaluation of the effectiveness of barron band ligation as a modality of treatment of hemorrhoids IOSR-JDMS 2014 13(10):39-46.10.9790/0853-131013946  [Google Scholar]  [CrossRef]

[20]. Bat L, Melzer E, Koler M, Dreznick Z, Shemesh E, Complications of rubber band ligation of symptomatic internal hemorrhoids Dis Colon Rectum 1993 36(3):287-90.0.1007/BF020535128449135  [Google Scholar]  [CrossRef]  [PubMed]