Crawshaw Benjamin P, Russ Andrew J, Ermlich Bridget O, Delaney Conor P, Champagne Bradley J
University Hospitals Case Medical Center, Cleveland, OH, USA
University Hospitals Case Medical Center, Cleveland, OH, USA.
Surg Innov. 2016 Dec;23(6):581-585. doi: 10.1177/1553350616660628. Epub 2016 Jul 23.
Background Existing nonsurgical procedures for the treatment of grade I and II internal hemorrhoids are often painful, technically demanding, and often necessitate multiple applications. This study prospectively assessed the safety and efficacy of the HET Bipolar System, a novel minimally invasive device, in the treatment of symptomatic grade I and II internal hemorrhoids. Methods Patients with symptomatic grade I or II internal hemorrhoids despite medical management underwent hemorrhoidal ligation with the HET Bipolar System. Endpoints included resolution or improvement of hemorrhoidal bleeding and/or prolapse from baseline, recurrent or refractory symptoms, and pain. Results Twenty patients were treated with the HET Bipolar System. Two were lost to follow-up. Refractory or recurrent bleeding was present in 8 of 18 (44.4%), 4 of 11 (36.4%), and 4 of 8 (50.0%) patients, and prolapse was reported by 1 of 18 (5.6%), 4 of 11 (36.4%), and 1/7 (14.3%) of patients at 1, 3, and 6 months, respectively. Bleeding improved from baseline in 88.2%, 81.8%, and 87.5% of patients, and resolution of baseline prolapse was seen in 11 of 11 (100%), 4 of 7 (57.1%), and 5 of 5 (100%) patients at the same intervals. Thirteen of 18 (72.2%) patients did not require additional treatment for their symptoms. Conclusions The HET Bipolar System is safe and easy to use with short-term effectiveness comparable to that of currently used techniques for the treatment of symptomatic grade I and II internal hemorrhoids. It may be an effective alternative to rubber band ligation in patients with larger internal hemorrhoids and those with hemorrhoids close to the dentate line in which banding may produce debilitating pain.
背景 现有的用于治疗I级和II级内痔的非手术方法通常很痛苦,技术要求高,且常常需要多次应用。本研究前瞻性地评估了一种新型微创设备HET双极系统治疗有症状的I级和II级内痔的安全性和有效性。方法 尽管经过药物治疗仍有症状的I级或II级内痔患者接受了HET双极系统痔结扎术。终点指标包括痔出血和/或脱垂相对于基线的缓解或改善情况、复发或难治性症状以及疼痛。结果 20例患者接受了HET双极系统治疗。2例失访。18例患者中有8例(44.4%)、11例患者中有4例(36.4%)、8例患者中有4例(50.0%)出现难治性或复发性出血,分别有18例患者中的1例(5.6%)、11例患者中的4例(36.4%)、7例患者中的1例(14.3%)在1、3和6个月时报告有脱垂。出血相对于基线得到改善的患者分别为88.2%、81.8%和87.5%,在相同时间间隔内,11例患者中的11例(100%)、7例患者中的4例(57.1%)、5例患者中的5例(100%)基线脱垂得到缓解。18例患者中有13例(72.2%)症状无需额外治疗。结论 HET双极系统安全且易于使用,其短期疗效与目前用于治疗有症状的I级和II级内痔的技术相当。对于内痔较大以及内痔靠近齿状线的患者,使用橡皮圈套扎可能会产生使人衰弱的疼痛,HET双极系统可能是橡皮圈套扎的有效替代方法。