HET Bipolar System: Validation of a New Minimally Invasive Outpatient Treatment for Symptomatic Hemorrhoids

HET Bipolar System: Validation of Outpatient Hemorrhoid Treatment

Introduction: This study will evaluate the effectiveness of treatment of Grade I-II hemorrhoids with the novel HET Bipolar System (Medtronic, Boulder, Co.). This device is a modified anoscope equipped with LED lighting, tissue clamping mechanism and bipolar energy device. It is inserted in the anus under direct vision targeting the tissue proximal to the hemorrhoid, which is placed within the treatment window and clamped. The bipolar energy device is activated to ligate the feeding hemorrhoidal vessels, essentially disrupting the blood supply to the hemorrhoid. The only published evaluation of this device to date is a retrospective analysis of the safety and efficacy of the device in 23 patients (1).

There is no prospective study of this device and its effectiveness in the literature. The investigators aim to evaluate the efficacy of this device, defined as decrease in symptoms and/or recurrence, of Grade I-II hemorrhoids through a prospective study consisting of 30 patients. Other non invasive means of treating hemorrhoids range from sclerotherapy to rubber band ligation, which often requires multiple treatments and can cause some discomfort. The investigators aim to study HET Bipolar treatment of hemorrhoids to offer another validated minimally invasive option for the treatment of symptomatic hemorrhoids in the outpatient setting.

Research Design and Method: The investigators will enroll a total of 30 subjects. Participating patients,18 years of age and older, will be undergoing treatment with the HET bipolar system for symptomatic Grade I and II hemorrhoids. Please note that the HET bipolar system is used as part of standard of care and participants will receive the treatment regardless of this research. The subjects will be identified and recruited by University of Illinois at Chicago Department of Colorectal Surgery faculty via clinic appointments in the Outpatient Care Center, 1801 W. Taylor St, Suite 3F, Chicago, Il 60612. Informed consent will be provided at the clinic in regards to participation in the study. Refusal to participate will not influence treatment options presented or deemed necessary for the subject's condition. A pretreatment hemorrhoid symptom questionnaire will be completed by each patient. In developing our questionnaire the investigators examined the only validated hemorrhoidal symptom questionnaire in the literature, the Sodergren Score (2) and also various others (3). The Sodergren score offers a theoretical basis, however the investigators chose to develop a questionnaire secondary to the need for inclusion of bleeding symptoms of hemorrhoids. While subjects are undergoing treatment, the investigators will record timing of treatment, number of hemorrhoids treated, and energy application timing. Immediately after the treatment, the patients will describe how painful the procedure was using the Visual Analog Scale (VAS). The questionnaire will take 5-10 minutes to complete. Patients will be seen for follow up outpatient clinic visits at 2-3 weeks and at 8-12 weeks post procedure. At follow up, the patients will be given a post-treatment questionnaire regarding symptoms of hemorrhoids (this is the same questionnaire as the pre-treatment questionnaire). The questionnaire assigns each of the five cardinal symptoms of hemorrhoids with a number from 0 to 3 with 3 being the most severe symptom. After tallying the five symptom scores, a total from 0 (no symptoms) to 15 (severe symptoms) will be assigned to each patient's overall symptoms. In addition, patients will be given a journal to record their daily pain for 14 consecutive days, day 21 and day 56 using the Visual Analog Scale (VAS). This is to more accurately record pain, as the questionnaire does not include a VAS score component. Patients who are unable to come for follow up visits will be interviewed over the phone by one of the investigators and the relevant data, i.e. the questionnaire and pain score, will be obtained during this phone conversation. For patients following up over the phone, a phone script will be created in addition to the questionnaire. The total number of visits/encounters is 3 and will take place during regular clinic visit appointments. The difference between pre treatment and post treatment scores will be representative of the treatment effect.

Statistical Section: