New Technology for Minimally-invasive Treatment of Symptomatic Grade I and II Hemorrhoids: Prospective Pilot Study With 1-year Follow-up.

 

Objective. To describe initial clinical experience with new minimally-invasive device for the treatment of symptomatic Grade I and II hemorrhoids.

Background. The symptomatic Grade I and II hemorrhoids are currently treated using rubber band ligation or other modalities such as infrared coagulation, RF bipolar energy or direct current. While these methods are relatively simple, they are often associated with post-procedural complications, pain or discomfort. There is a need, therefore, for a new technology, which causes less post-procedural pain and discomfort, results in good consistent outcomes and is simple to use. The HET Bipolar device is a new device for the treatment of symptomatic Grade I and II hemorrhoids.

Patients and materials. Twenty-two patients with Grade I and II hemorrhoids were treated with The HET Bipolar forceps (HET Systems, Northvale, NJ, USA), a new device for tissue manipulation and coagulation. The study was conducted with the permission of the institutional review committee. All patients (100%) had rectal bleeding and 16 patients (72.7%) had spontaneously reducible prolapse. The HET Bipolar device was connected to the Hyfrecator 2000 (Conmed, USA) as a power source and to the temperature monitor. The HET Bipolar device, which resembles a small anoscope, was inserted in the anal canal. The tissue fold above the dentate line, just proximal to and/or including the portion of the internal hemorrhoid was ligated and treated with bipolar radio-frequency (RF) energy at 10 Watts until the treated tissue temperature reached 55-60C. All three hemorrhoid bundles were treated in one procedure. The patients then were prospectively studied. All patients (100%) were followed at 4 weeks after the procedure. Sixteen patients (73%) were available at an average 13.1 months follow-up.

Results. The procedure was simple, and the device was easy to use. Time of RF energy applications ranged from 7 to 26 sec. At 4 weeks follow-up, the rectal bleeding and prolapse, which were the indications for the procedure, subsided in 86.7% and 67.8% of patients, respectively. At an average 13.1 months follow-up, the rectal bleeding resolved in 95.5%. No patients reported prolapse at an average 13.1 months follow-up (100%). Two patients (9%) reported some worsening of their pre-procedural anal pain. However, all patients reported improvement or resolution of their pre-procedural symptoms at an average follow-up of 13.1 months.

Conclusions. The newly developed HET Bipolar device was found to be safe, easy to use, well-tolerated by the patients, and resulted in either complete or near complete resolution of the symptoms in patients with Grade I and II hemorrhoids. Although the results of this study are encouraging, the additional studies are needed to further evaluate the HET Bipolar technology in the treatment of symptomatic hemorrhoidal ano-rectal disease.

 

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