Randomized Trial Comparing a Starion(TM) and a Harmonic Scalpel(TM) Hemorrhoidectomy

ABSTRACT

PURPOSE: The present study was designed to evaluate the efficacy and the outcome when using the Starion(TM) and the Harmonic Scalpel(TM) vessel sealing systems for a sutureless hemorrhoidectomy. METHODS: This study is a randomized, controlled trial. Patients with Grade 3 and 4 hemorrhoids were categorized into two groups: the Starion(TM) hemorrhoidectomy (30 patients) group and the Harmonic Scalpel(TM) hemorrhoidectomy (30 patients) group. The measures of the primary outcomes were the operating time, the postoperative pain score, and the patient satisfaction score. Secondary outcome criteria included early and delayed complications: postoperative bleeding, anal stenosis, urinary difficulty, and skin tag. RESULTS: The satisfaction scores 4 wk postoperatively were not significantly different between the two groups (P=0.186). However, the operating time was reduced (P=0.019), the pain score was lower (P=0.009), and the satisfaction score 1 wk postoperatively (P=0.001) was lower in the Starion(TM) hemorrhoidectomy group. In addition, there were no differences in early and delayed postoperative complications between the two groups (all P>0.05). CONCLUSION: Both methods were found to be surprisingly equivalent in all major aspects analyzed. A Starion(TM) hemorrhoidectomy with submucosal dissection can provide a safe, fast, bloodless, reduced-pain, and low-priced surgical alternative to hemorrhoidal surgery. More studies are needed to determine whether similar favorable results can be attained in patients with more severe, strangulated hemorrhoids.