Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease

Summary

Background: Hemorrhoidal disease is extremely frequent in the adult population and, as a benign pathology, the treatment should be guided by the patient's symptoms. Treatment of hemorrhoidal disease includes a conservative approach, office-based treatments and surgery. This study is aimed to evaluate and compare the efficacy and safety of the treatment of hemorrhoidal disease with non-surgical office-based method polidocanol foam sclerotherapy (SP) and the surgical technique doppler-guided hemorrhoidal artery ligation with recto-anal repair. Methods: Prospective, unicentric study including patients with symptomatic hemorrhoidal disease grade II and III refractory to conservative therapy, submitted either to SP (n=24) or to HAL-RAR procedure (n=21), during a recruitment period of 6 months. Patients were evaluated for efficacy (Sodergren's scale of symptoms and severity of bleeding) and safety (complications and implication in personal and professional life), up to one month after treatment. In follow-up period (6 months) participants were evaluated for hemorrhoidal disease recurrence.

Timeline

Start

2019-09-01

Primary completion

2020-02-01

Completion

2020-03-25

Publications

• Background Sun Z, Migaly J. Review of Hemorrhoid Disease: Presentation and Management. Clin Colon Rectal Surg. 2016 Mar;29(1):22-9. doi: 10.1055/s-0035-1568144.
• Background Sneider EB, Maykel JA. Diagnosis and management of symptomatic hemorrhoids. Surg Clin North Am. 2010 Feb;90(1):17-32, Table of Contents. doi: 10.1016/j.suc.2009.10.005.
• Background Rakinic J, Poola VP. Hemorrhoids and fistulas: new solutions to old problems. Curr Probl Surg. 2014 Mar;51(3):98-137. doi: 10.1067/j.cpsurg.2013.11.002. Epub 2013 Nov 25.
• Background Lohsiriwat V. Hemorrhoids: from basic pathophysiology to clinical management. World J Gastroenterol. 2012 May 7;18(17):2009-17. doi: 10.3748/wjg.v18.i17.2009.
• Background Lohsiriwat V. Approach to hemorrhoids. Curr Gastroenterol Rep. 2013 Jul;15(7):332. doi: 10.1007/s11894-013-0332-6.
• Background Peery AF, Sandler RS, Galanko JA, Bresalier RS, Figueiredo JC, Ahnen DJ, Barry EL, Baron JA. Risk Factors for Hemorrhoids on Screening Colonoscopy. PLoS One. 2015 Sep 25;10(9):e0139100. doi: 10.1371/journal.pone.0139100. eCollection 2015.
• Background Faccini M, Zuccon W, Caputo P, Gavezzoli D, Manelli A, Bonandrini L. [Hemorrhoids: epidemiology and correlation with chronic constipation]. Ann Ital Chir. 2001 May-Jun;72(3):337-9; discussion 340. Italian.
• Background Pigot F, Siproudhis L, Allaert FA. Risk factors associated with hemorrhoidal symptoms in specialized consultation. Gastroenterol Clin Biol. 2005 Dec;29(12):1270-4. doi: 10.1016/s0399-8320(05)82220-1.
• Background Riss S, Weiser FA, Schwameis K, Riss T, Mittlbock M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012 Feb;27(2):215-20. doi: 10.1007/s00384-011-1316-3. Epub 2011 Sep 20.
• Background Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation. An epidemiologic study. Gastroenterology. 1990 Feb;98(2):380-6. doi: 10.1016/0016-5085(90)90828-o.
• Background Lohsiriwat V. Treatment of hemorrhoids: A coloproctologist's view. World J Gastroenterol. 2015 Aug 21;21(31):9245-52. doi: 10.3748/wjg.v21.i31.9245.
• Background Hollingshead JR, Phillips RK. Haemorrhoids: modern diagnosis and treatment. Postgrad Med J. 2016 Jan;92(1083):4-8. doi: 10.1136/postgradmedj-2015-133328. Epub 2015 Nov 11.
• Background Qureshi WA. Office management of hemorrhoids. Am J Gastroenterol. 2018 Jun;113(6):795-798. doi: 10.1038/s41395-018-0020-0. No abstract available.
• Background Pucher PH, Qurashi M, Howell AM, Faiz O, Ziprin P, Darzi A, Sodergren MH. Development and validation of a symptom-based severity score for haemorrhoidal disease: the Sodergren score. Colorectal Dis. 2015 Jul;17(7):612-8. doi: 10.1111/codi.12903.
• Background Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.
• Background Park SK, Ko BM, Goong HJ, Seo JY, Lee SH, Baek HL, Lee MS, Park DI. Short health scale: A valid measure of health-related quality of life in Korean-speaking patients with inflammatory bowel disease. World J Gastroenterol. 2017 May 21;23(19):3530-3537. doi: 10.3748/wjg.v23.i19.3530.
• Background Sandler RS, Peery AF. Rethinking What We Know About Hemorrhoids. Clin Gastroenterol Hepatol. 2019 Jan;17(1):8-15. doi: 10.1016/j.cgh.2018.03.020. Epub 2018 Mar 27.
• Background Jacobs D. Clinical practice. Hemorrhoids. N Engl J Med. 2014 Sep 4;371(10):944-51. doi: 10.1056/NEJMcp1204188. No abstract available.
• Background Ganz RA. The evaluation and treatment of hemorrhoids: a guide for the gastroenterologist. Clin Gastroenterol Hepatol. 2013 Jun;11(6):593-603. doi: 10.1016/j.cgh.2012.12.020. Epub 2013 Jan 16. No abstract available.
• Background Iyer VS, Shrier I, Gordon PH. Long-term outcome of rubber band ligation for symptomatic primary and recurrent internal hemorrhoids. Dis Colon Rectum. 2004 Aug;47(8):1364-70. doi: 10.1007/s10350-004-0591-2.
• Background Cocorullo G, Tutino R, Falco N, Licari L, Orlando G, Fontana T, Raspanti C, Salamone G, Scerrino G, Gallo G, Trompetto M, Gulotta G. The non-surgical management for hemorrhoidal disease. A systematic review. G Chir. 2017 Jan-Feb;38(1):5-14. doi: 10.11138/gchir/2017.38.1.005.
• Background Albuquerque A. Rubber band ligation of hemorrhoids: A guide for complications. World J Gastrointest Surg. 2016 Sep 27;8(9):614-620. doi: 10.4240/wjgs.v8.i9.614.
• Background Acheson AG, Scholefield JH. Management of haemorrhoids. BMJ. 2008 Feb 16;336(7640):380-3. doi: 10.1136/bmj.39465.674745.80. No abstract available.
• Background Song SG, Kim SH. Optimal treatment of symptomatic hemorrhoids. J Korean Soc Coloproctol. 2011 Dec;27(6):277-81. doi: 10.3393/jksc.2011.27.6.277. Epub 2011 Dec 31.
• Background Hachiro Y, Kunimoto M, Abe T, Kitada M, Ebisawa Y. Aluminum potassium sulfate and tannic acid (ALTA) injection as the mainstay of treatment for internal hemorrhoids. Surg Today. 2011 Jun;41(6):806-9. doi: 10.1007/s00595-010-4386-x. Epub 2011 May 28.
• Background Hussar DA, Stevenson T. New drugs: Denosumab, dienogest/estradiol valerate, and polidocanol. J Am Pharm Assoc (2003). 2010 Sep-Oct;50(5):658-62. doi: 10.1331/JAPhA.2010.10536. No abstract available.
• Background Moser KH, Mosch C, Walgenbach M, Bussen DG, Kirsch J, Joos AK, Gliem P, Sauerland S. Efficacy and safety of sclerotherapy with polidocanol foam in comparison with fluid sclerosant in the treatment of first-grade haemorrhoidal disease: a randomised, controlled, single-blind, multicentre trial. Int J Colorectal Dis. 2013 Oct;28(10):1439-47. doi: 10.1007/s00384-013-1729-2. Epub 2013 Jun 18.
• Background Yuksel BC, Armagan H, Berkem H, Yildiz Y, Ozel H, Hengirmen S. Conservative management of hemorrhoids: a comparison of venotonic flavonoid micronized purified flavonoid fraction (MPFF) and sclerotherapy. Surg Today. 2008;38(2):123-9. doi: 10.1007/s00595-007-3582-9. Epub 2008 Feb 1.
• Background Nastasa V, Samaras K, Ampatzidis Ch, Karapantsios TD, Trelles MA, Moreno-Moraga J, Smarandache A, Pascu ML. Properties of polidocanol foam in view of its use in sclerotherapy. Int J Pharm. 2015 Jan 30;478(2):588-96. doi: 10.1016/j.ijpharm.2014.11.056. Epub 2014 Nov 26.
• Background Tessari L, Cavezzi A, Frullini A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. Dermatol Surg. 2001 Jan;27(1):58-60.
• Background Cavezzi A, Tessari L. Foam sclerotherapy techniques: different gases and methods of preparation, catheter versus direct injection. Phlebology. 2009 Dec;24(6):247-51. doi: 10.1258/phleb.2009.009061.
• Background Scaglia M, Delaini GG, Destefano I, Hulten L. Injection treatment of hemorrhoids in patients with acquired immunodeficiency syndrome. Dis Colon Rectum. 2001 Mar;44(3):401-4. doi: 10.1007/BF02234740.
• Background Clinical Practice Committee, American Gastroenterological Association. American Gastroenterological Association medical position statement: Diagnosis and treatment of hemorrhoids. Gastroenterology. 2004 May;126(5):1461-2. doi: 10.1053/j.gastro.2004.03.001.
• Background Conaghan P, Farouk R. Doppler-guided hemorrhoid artery ligation reduces the need for conventional hemorrhoid surgery in patients who fail rubber band ligation treatment. Dis Colon Rectum. 2009 Jan;52(1):127-30. doi: 10.1007/DCR.0b013e3181973639.
• Background Ohning GV, Machicado GA, Jensen DM. Definitive therapy for internal hemorrhoids--new opportunities and options. Rev Gastroenterol Disord. 2009 Winter;9(1):16-26.
• Background Peng BC, Jayne DG, Ho YH. Randomized trial of rubber band ligation vs. stapled hemorrhoidectomy for prolapsed piles. Dis Colon Rectum. 2003 Mar;46(3):291-7; discussion 296-7. doi: 10.1007/s10350-004-6543-z.
• Background Watson AJ, Bruhn H, MacLeod K, McDonald A, McPherson G, Kilonzo M, Norrie J, Loudon MA, McCormack K, Buckley B, Brown S, Curran F, Jayne D, Rajagopal R, Cook JA; eTHoS study group. A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial. Trials. 2014 Nov 11;15:439. doi: 10.1186/1745-6215-15-439.
• Background Yano T, Asano M, Tanaka S, Oda N, Matsuda Y. Prospective study comparing the new sclerotherapy and hemorrhoidectomy in terms of therapeutic outcomes at 4 years after the treatment. Surg Today. 2014 Mar;44(3):449-53. doi: 10.1007/s00595-013-0564-y. Epub 2013 Mar 30.
• Background Yeo D, Tan KY. Hemorrhoidectomy - making sense of the surgical options. World J Gastroenterol. 2014 Dec 7;20(45):16976-83. doi: 10.3748/wjg.v20.i45.16976.
• Background Morinaga K, Hasuda K, Ikeda T. A novel therapy for internal hemorrhoids: ligation of the hemorrhoidal artery with a newly devised instrument (Moricorn) in conjunction with a Doppler flowmeter. Am J Gastroenterol. 1995 Apr;90(4):610-3.
• Background Ratto C. THD Doppler procedure for hemorrhoids: the surgical technique. Tech Coloproctol. 2014 Mar;18(3):291-8. doi: 10.1007/s10151-013-1062-3. Epub 2013 Sep 12.
• Background Hoyuela C, Carvajal F, Juvany M, Troyano D, Trias M, Martrat A, Ardid J, Obiols J. HAL-RAR (Doppler guided haemorrhoid artery ligation with recto-anal repair) is a safe and effective procedure for haemorrhoids. Results of a prospective study after two-years follow-up. Int J Surg. 2016 Apr;28:39-44. doi: 10.1016/j.ijsu.2016.02.030. Epub 2016 Feb 10.
• Background Giordano P, Overton J, Madeddu F, Zaman S, Gravante G. Transanal hemorrhoidal dearterialization: a systematic review. Dis Colon Rectum. 2009 Sep;52(9):1665-71. doi: 10.1007/DCR.0b013e3181af50f4.
• Background De Nardi P, Capretti G, Corsaro A, Staudacher C. A prospective, randomized trial comparing the short- and long-term results of doppler-guided transanal hemorrhoid dearterialization with mucopexy versus excision hemorrhoidectomy for grade III hemorrhoids. Dis Colon Rectum. 2014 Mar;57(3):348-53. doi: 10.1097/DCR.0000000000000085.
• Background Denoya PI, Fakhoury M, Chang K, Fakhoury J, Bergamaschi R. Dearterialization with mucopexy versus haemorrhoidectomy for grade III or IV haemorrhoids: short-term results of a double-blind randomized controlled trial. Colorectal Dis. 2013;15(10):1281-8. doi: 10.1111/codi.12303.
• Background Elmer SE, Nygren JO, Lenander CE. A randomized trial of transanal hemorrhoidal dearterialization with anopexy compared with open hemorrhoidectomy in the treatment of hemorrhoids. Dis Colon Rectum. 2013 Apr;56(4):484-90. doi: 10.1097/DCR.0b013e31827a8567.
• Background Giamundo P. Advantages and limits of hemorrhoidal dearterialization in the treatment of symptomatic hemorrhoids. World J Gastrointest Surg. 2016 Jan 27;8(1):1-4. doi: 10.4240/wjgs.v8.i1.1.
• Background Brown SR, Tiernan JP, Watson AJM, Biggs K, Shephard N, Wailoo AJ, Bradburn M, Alshreef A, Hind D; HubBLe Study team. 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 Jul 23;388(10042):356-364. doi: 10.1016/S0140-6736(16)30584-0. Epub 2016 May 25.
• Background Fernandes V, Fonseca J. Polidocanol Foam Injected at High Doses with Intravenous Needle: The (Almost) Perfect Treatment of Symptomatic Internal Hemorrhoids. GE Port J Gastroenterol. 2019 May;26(3):169-175. doi: 10.1159/000492202. Epub 2018 Aug 31.
• Background Lobascio P, Laforgia R, Novelli E, Perrone F, Di Salvo M, Pezzolla A, Trompetto M, Gallo G. Short-Term Results of Sclerotherapy with 3% Polidocanol Foam for Symptomatic Second- and Third-Degree Hemorrhoidal Disease. J Invest Surg. 2021 Oct;34(10):1059-1065. doi: 10.1080/08941939.2020.1745964. Epub 2020 Apr 15.
• Background Forlini A, Manzelli A, Quaresima S, Forlini M. Long-term result after rubber band ligation for haemorrhoids. Int J Colorectal Dis. 2009 Sep;24(9):1007-10. doi: 10.1007/s00384-009-0698-y. Epub 2009 Apr 23.
• Background Azizi R, Rabani-Karizi B, Taghipour MA. Comparison between Ultroid and rubber band ligation in treatment of internal hemorrhoids. Acta Med Iran. 2010 Nov-Dec;48(6):389-93.
• Background Watson NF, Liptrott 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 May;88(3):275-9. doi: 10.1308/003588406X98649.
• Background Pol RA, van der Zwet WC, Hoornenborg D, Makkinga B, Kaijser M, Eeftinck Schattenkerk M, Eddes EH. Results of 244 consecutive patients with hemorrhoids treated with Doppler-guided hemorrhoidal artery ligation. Dig Surg. 2010;27(4):279-84. doi: 10.1159/000280020. Epub 2010 Jul 31.
• Background Walega P, Romaniszyn M, Kenig J, Herman R, Nowak W. Doppler-guided hemorrhoid artery ligation with Recto-Anal-Repair modification: functional evaluation and safety assessment of a new minimally invasive method of treatment of advanced hemorrhoidal disease. ScientificWorldJournal. 2012;2012:324040. doi: 10.1100/2012/324040. Epub 2012 Apr 1.
• Background Wilkerson PM, Strbac M, Reece-Smith H, Middleton SB. Doppler-guided haemorrhoidal artery ligation: long-term outcome and patient satisfaction. Colorectal Dis. 2009 May;11(4):394-400. doi: 10.1111/j.1463-1318.2008.01602.x. Epub 2008 Jun 28.
• Background Alshreef A, Wailoo AJ, Brown SR, Tiernan JP, Watson AJM, Biggs K, Bradburn M, Hind D. Cost-Effectiveness of Haemorrhoidal Artery Ligation versus Rubber Band Ligation for the Treatment of Grade II-III Haemorrhoids: Analysis Using Evidence from the HubBLe Trial. Pharmacoecon Open. 2017 Sep;1(3):175-184. doi: 10.1007/s41669-017-0023-6.
• Neves S, Falcao D, Povo A, Castro-Pocas F, Oliveira J, Salgueiro P. 3% polidocanol foam sclerotherapy versus hemorrhoidal artery ligation with recto anal repair in hemorrhoidal disease grades II-III: a randomized, pilot trial. Rev Esp Enferm Dig. 2023 Mar;115(3):115-120. doi: 10.17235/reed.2022.8568/2022.

Drugs

Indications