Rubber Band Ligation in Early Stage Hemorrhoids: Outcome & Efficacy in Today s Era

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1 Original Research Article Rubber Band Ligation in Early Stage Hemorrhoids: Outcome & Efficacy in Today s Era Dr. Raj Ratan 1, Dr. P. P. Rao 2 1Graded Specialist (Surgery), Command Hospital, Pune and Assistant Professor, Dept. of Surgery, Armed Forces Medical College, Pune, Maharashtra, India 2Senior Adviser (Dept. of GI Surgery), Command Hospital, Pune and Professor Dept. of Surgery, Armed Forces Medical College, Pune, Maharashtra, India Corresponding author: Dr. P. P. Rao Abstract Introduction: Hemorrhoids are a common surgical problem seen in the outpatient department. A number of new surgical treatments have led to a reappraisal of hemorrhoid disease over the last few decades. Despite a range of treatment modalities, the options are limited in their effectiveness and can lead to a number of complications. Rubber band ligation is a common office procedure for hemorrhoids. It has been shown to be a safe and economical way of treating hemorrhoids. This prospective observational study was carried out to assess the efficacy, effectiveness and complications of rubber band ligation performed as an outpatient procedure for symptomatic hemorrhoids in today s era of other newer modalities of treatment like stapled haemorrhoidectomy, infrared coagulation, and hemorrhoid laser procedure. Methods: 100 consecutive patients with symptomatic second and third degree hemorrhoids underwent rubber band ligation in the outpatient clinic of the department of GI surgery at a tertiary care hospital in Pune. Outcome measured were symptomatic cure i.e. stoppage of bleeding and reduced mucosal prolapse. Complications were categorized as immediate, early (within one week) and late (within 3 months). Results: Symptomatic cure was achieved in 89% patients (stoppage of bleeding and reduced mucosal prolapse). Eleven patients required further banding. Pain (mild to severe) was most common immediate and intermediate complication (20 and 10 patients respectively). Conclusion: Rubber band ligation is still an effective, cost-effective office procedure for symptomatic hemorrhoids, associated with minimal morbidity. Key-words: Hemorrhoids, Banding, Ligation. Introduction: Hemorrhoids are among the commonest surgical ailments of anorectal region seen in the outpatient department.[1] These are usually associated with distressing symptoms. The incidence of hemorrhoids increases with age. Shyness and fear are the main reasons of avoiding treatment. Treatment of hemorrhoids has remained controversial among surgeons all over the world. For the last many decades surgeons have treatment, which would give good results with minimum complications.[2] Most patients in initial stages are treated with conservative or minimally invasive approaches. Injection sclerotherapy and rubber band ligation (RBL) are two common non-surgical OPD 66

2 procedures. Rubber band ligation is considered as one of the commonly available treatment options for management of hemorrhoids in outpatient settings. A simple, safe and effective method, RBL has emerged as a successful modality of treatment for symptomatic first-, second-, and third-degree hemorrhoids as an outpatient procedure with significant improvement in quality of life. In this article we will present the outcome of rubber band ligation in patients who presented or were referred for the treatment of hemorrhoids in the outpatient clinic of the department of GI surgery at a tertiary care hospital in Pune. Material and Methods: This study was conducted at the outpatient clinic of the department of GI surgery at a tertiary care hospital in Pune, from Jun 2015 to Dec Hundred consecutive patients with symptomatic second and third degree hemorrhoids were included as shown in Table 1. After complete history and examination (both digital rectal examination and proctoscopy) diagnosis and degree of hemorrhoids was confirmed. Rigid sigmoidoscopy was performed in selected cases. The indications for sigmoidoscopy were other symptoms like change in bowel habit, diarrhea and haematochezia and to rule out any malignant pathology in the distal colon. All patients were explained about the procedure and its complications and other treatment options available. An informed consent was obtained. Rubber band ligation using Barrons ligator[3] was done in OPD..Table 1: Degree of Hemorrhoids Degree Number of Cases Percentage 2nd (11o) 3rd (111o) % % Patient was placed in left lateral position. Routine rectal examination and proctoscopy was performed to ascertain the degree of hemorrhoids. The base of hemorrhoids was clearly identified and bands were applied above the dentate line using ligator (Figure- 1). A maximum of two hemorrhoids were banded at single sitting. Repeat banding was done after 4 weeks when needed. Following the procedure, patients were asked to rate the discomfort / pain on a scale of The pain was graded as mild (1-3), moderate (4-6) and severe (7-10). The patients were observed for immediate complications for 30 minutes and were followed up for intermediate complications (within 1 week) and late (within 3 months) in the OPD. Data was analyzed by using SPSS version 10 and p-value was calculated using chi square test. Results: In our study there were 100 patients out of which 80 (80%) were male and 20 (20%) were female. All the patients had the symptoms of bleeding per rectum and prolapse while 31(31%) had complaints of itching / pruritus ani and 29(29%) had complaints of pain and discomfort. Maximum percentage of cases was symptomatic from 6months to 2 years (60%). Total 216 bands were applied (two per single sitting) and repeat banding was done in 11 (11%) cases that had recurrence after 3 months. The comparative outcome and complications are given in the tables 2 and 3

3 Table 2: Immediate Complications of Suction Band Ligation Problem Total No Pain 80 Mild Pain 17 Moderate Pain 02 Severe Pain 01 Vasovagal episode 00 Bleeding 02 Table 3: Intermediate Complications of Suction Band Ligation Complication Consultant Discomfort/mild Pain 08 Moderate Pain 02 Severe Pain 00 Fever with Rigors 00 Slippage of Band 00 Total 10 22% patients had immediate complications (Table 2) while 10% patients experienced intermediate complications (Table 3). There were no late and serious complications like sepsis, massive bleeding necrosis, ulceration and stenosis. There was no mortality. After three months follow up 91 patients had symptomatic cure and 11 patients had recurrence of hemorrhoids. Discussion: to be established. It is a condition with a variety of symptoms and a spectrum of severity. The large number of treatment options reflects this. Hemorrhoids affect between 4.4 and 36.4% of the general population.[5] Only in the last 30 years have anatomical and histological[6] studies been used to characterize their anatomy and etiology. This has led to resurgence in interest in the condition associated with the development of a number of Hemorrhoids have been treated by surgeons for novel treatments. Nevertheless, the surgical centuries. Therapies for the topical treatment of hemorrhoids date back to Egyptian papyri of 1700 BC. The first surgical treatment was described in the Hippocratic Treatises of 460 BC, and suggested transfixing them with a needle and tying them with a very thick and large woolen thread.[4] Despite centuries of treating the condition, its precise etiology is unclear and a definitive treatment is yet management of hemorrhoids is often based more on anecdote than science. Many myths continue to perpetuate in both lay and professional circles. Banding or ligation of the hemorrhoidal mass has been the basis of many hemorrhoidal treatments over the centuries.[7] RBL was introduced by Blaisdell in Barron popularized the said procedure and thus RBL became known by his 68

4 name. Obliteration of the vessels feeding the hemorrhoid leads to ulceration and sloughing, with subsequent healing over a period of weeks It is imperative to identify the level of the dentate line and carry out the procedure above this level. Selection of banding site above dentate line reduces discomfort and pain. It is usually advocated in grade II, III and even in IV hemorrhoids. Barron originally advocated the ligation of one hemorrhoid at a time, with future bandings at 3-week intervals. Studies have shown, however, that there is no significant increase in patient discomfort or the predicted problems of anal stenosis, with multiple bandings in a single session.[8] None of our patients had symptoms of anal stenosis though the length of follow up in our study is only 3 months. Larger trials [9] and meta-analysis [10] show rubber band ligation to be both more effective and less likely to require further therapy than injection. This is shown for first and second-degree hemorrhoids as well as third. Studies have also shown banding to be superior to photocoagulation.[11] A new stapling technique, the procedure for prolapse and hemorrhoids (PPH), was introduced in the mid-1990s and has been used extensively since then for grade III and grade IV hemorrhoids. It is also known as stapled hemorrhoidopexy. A number of studies endorse RBL as a first-line option for grade III hemorrhoids.[12] However, one should note that RBL carries a high potential for symptomatic recurrence, which often results in the need for multiple bandings.[15] Peng and colleagues [13] conducted a study in which 55 patients with grade III or small grade IV hemorrhoids were randomized to either RBL or PPH.[15] There was a higher incidence of pain at discharge and at 2-week follow-up in the PPH group (P<.001). Six patients in the PPH group experienced procedure-related complications, as opposed to none in the RBL group (P=.027). Moreover, PPH is undertaken as an in patient procedure requiring spinal anaesthesia. Despite better outcomes, Hemorrhoidectomy has been associated with more complications, time off work and pain than RBL.[19, 20] Arroyo A and associates[21] concluded that open hemorrhoidectomy was followed by significant pain in the post-operative phase. RBL is a relatively safe office procedure requiring no hospitalization. More than 90% of our patients could resume their normal daily activities after 2 days. It is best suited and easily carried out even as a bed side procedure in patients who are unfit for anesthesia. However, it is unsuitable for first degree, especially in early cases where there is insufficient tissue available to pull in to the ligature drum to make the method worthwhile and in any event, such small piles can be as effectively managed by injection sclerotherapy. The study by MacRae et al[19] promotes consideration of RBL for second & third degree hemorrhoids, commonly indicated for bleeding and/or prolapsing. Surgical management shall be considered in the presence of an important external component, thrombosis of the hemorrhoid or recurrence after bleeding.[20] Vaghasiya GN et al[22] in their comparative study of band ligation vs sclerotherapy on internal hemorrhoids found both the procedures to be simple, safe, not requiring any expertise/skill or anaesthesia. Hemorrhoid laser procedure is a newer modality of management of internal hemorrhoids in which hemorrhoidal arterial flow feeding the hemorrhoidal plexus is ceased by means of Doppler-guided laser coagulation. Giamundo P et al[23] reported no 69

5 significant differences between rubber band ligation and hemorrhoid laser procedure in operative time or intraoperative morbidity. The hemorrhoid laser procedure is a costly procedure as compared to RBL. Infra-red Coagulation (IRC) is another recent modality of management of internal hemorrhoids which promises to eliminate the post ligation pain and discomfort that occurs with RBL.[24] Both, RBL & Infrared photocoagulation are office procedures and almost have similar efficacies & clinical outcomes. The only advantage with IRC is that it s a painless procedure with least of complications. However the long term effectiveness of RBL is more than IRC.[25] The main criticism of RBL is that it does nothing to remove the skin-covered component of the pile or an associated skin covered component of the pile or an associated skin tag. The bothering skin tags may be removed under local anesthesia as an out door procedure later on.[14] Successful RBL was achieved in 89% of our patients similar to previous studies.[15] The complication rate was relatively low; most of the complications were minor and self-limiting in the form of mild to moderate pain. Kumar et al[16] described cure rate up to 71%, whereas in our study cure has been 89% and the incidence of immediate and intermediate complications was.3% and 74.4 respectively in their study whereas in our series it was 22% and 10% respectively which is quite less as compared to Kumar et al series. All these patients required observation for 1 hour and later discharged, no patient was admitted as in-patient. This is comparable to other international studies.[17] There were no late complications. Though very rare, but serious complications, like bleeding, sepsis and mortality have been reported. The incidence of complications in our series is less and not significant. Secondary hemorrhage which may be life threatening is another problem which may occur at home as the patient is treated on out patients basis. As far as complications of this method are concerned, delayed massive rectal bleeding, urinary retention, pain and fever, perianal abscess& perianal fistula, band related mucosal ulcer and priapism has been reported in the literature.[18] Conclusion: Large numbers of options are available for treating piles, ranging from simple advice of dietary manipulation to aggressive surgical intervention. Day care and less invasive procedures are more acceptable to the patients. RBL is an efficient, safe and acceptable office procedure with minimal morbidity enabling the patient early return to work. References: 1. Pasha J Nisar and John H Scholefield. Managing Hemorrhoids. BMJ 2003;327; A Hardy, C.L.H. Chan, C.R.G. Cohen. The surgical management of Hemorrhoids- A review. Dig Surg 2005;22: Barron J: Office ligation of hemorrhoids. Dis Colon Rectum 1963; 6: Cataldo P, Ellis CN, Gregorcyk S, et al. Practice parameters for the management of hemorrhoids (revised). Dis Colon Rectum. 2005;48:

6 5. Hulme-Moir M, Bartolo DC. Hemorrhoids. Gastroenterol Clin North Am 2001;30: Sardinha TC, Corman ML. Hemorrhoids. The Surgical clinics of North America 2002; Vol. 82, issue 6:1153{. [MedLine: ]. 7. Komborozos VA, Skrekas GJ, Pissiotis CA. Rubber band ligation of symptomatic internal hemorrhoids: results of 500 cases. Dig Surg. 2000;17: Armstrong DN. Multiple hemorrhoidal ligation: a prospective, randomized trial evaluating a new technique. Dis Colon Rectum 2003;46: Longman RJ, Thomson WH. A prospective study of outcome from rubber band ligation of piles. Colorectal Dis Feb;8(2): PMID: MacRae HM,McLeod RS. Comparison of Hemorrhoidal Treatment Modalities. A meta- analysis. Dis Colon Rectum 1995;38(7): [MedLine: ]. 11. Poen AC, Felt BRJ Cuesta M, Deville W, Meuwissen SG. A randomized controlled trial of RBL Vs infrared coagulation in the treatment of internal hemorrhoid Euro J of Gastroenterology 2000, 12: Singer MA, Cintron JR, Fleshman JW, et al. Early experience with stapled hemorrhoidectomy in the United States. Dis Colon Rectum. 2002;45: Peng BC, Jayne DG, Ho YH. Randomized trial of rubber band ligation vs. stapled hemorrhoidectomy for prolapsed piles. Dis Colon Rectum. 2003;46: Barrow E, Watson AJ. Outcome from rubber band ligation of piles. Colorectal Dis Mar;9(3):281. PMID: V. S. Iyer, M.D., I. Shrier, M.D., Ph.D., P. H. Gordon, M.D. Long-Term Outcome of Rubber Band Ligation for Symptomatic Primary and Recurrent Internal Hemorrhoids. Dis Colon Rectum 2004; 47: Kumar N, Paulvanan S, Billings PJ. Rubber band ligation of hemorrhoids in the out patient clinic. Ann R Coll Surg Engl 2002; 84: Benzoni E, Milan E, Cerato F, Narisetti P, Bresadola V, Terrosu G.Second degree hemorrhoids: patient's satisfaction, immediate and long-term results of rubber band ligation treatment. Minerva Chir Apr;61(2): MID: Thaha MA, Campbell KL, Steele RJC. Non-operative treatment for haemorrhoidal disease. In: The Cochrane Database of Systematic Reviews, 3, Chichester, UK: John Wiley & Sons, Ltd. 19. MacRae HM, McLeod RS. Comparison of hemorrhoidal treatment modalities. A meta-analysis. Dis Colon Rectum 1995; 38: Shanmugam V, Thaha MA, Rabindranath KS, Campbell KL, Steele RJ, Loudon MA. Rubber band ligation versus excisional hemorrhoidectomy for hemorrhoids. Cochrane Database Syst Rev 2005; (3): CD Arroyo A, Perez F, Miranda E, Serrano P, Candela F, Lacueva J et al. Open versus closed day case hemorrhoidectomy: is there any difference? Results of a prospective randomized study. Int J Colorectal Dis 2004; 19: Vaghasiya GN, Dave JP, Nilesh Ladumore. A comparative study of band ligation vs sclerotherapy in internal hemorrhoids. Int J Res Med 2015; 4(4);

7 23. Giamundo P, Salfi R, Geraci M, Tibaldi L, Murru L, Valente M. 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): Poen AC, Felt-Bersma RJ, Cuesta MA, Deville W & Meuwissen SG. A randomized controlled trial of rubber band ligation versus infra-red coagulation in the treatment of internal hemorrhoids. European Journal of Gastroenterology and Hepatology 2000; 12: Joahanson JF & Rimm A. Optimal nonsurgical treatment of hemorrhoids: a comparative analysis of infrared coagulation, rubber band ligation and injection sclerotherapy. American Journal of Gastroenterology 1992; 87: