PURPOSE: A randomized trial was undertaken to evaluate and compare stapled hemorrhoidopexy with excisional hemorrhoidectomy in which the Harmonic Scalpel (TM) was used. METHODS: Patients with Grade III hemorrhoids who were employed during the trial period were recruited and randomized into two groups: (1) Harmonic Scalpel (TM) hemorrhoidectomy, and (2) stapled hemorrhoidopexy. All operations were performed by a single surgeon. In the stapled group, the doughnut obtained was sent for histopathologic examination to determine whether smooth muscles were included in the specimen. Operative data and complications were recorded, and patients were followed up through a structured pro forma protocol. An independent assessor was assigned to obtain postoperative pain scores and satisfaction scores at six-month follow-up. Patients were also administered a simple questionnaire at follow-up to assess continence functions. RESULTS: Over a 20-month period, 88 patients were recruited. The two groups were matched for age and gender distribution. No significant difference was identified between the two groups in terms of operation time, blood loss, day of first bowel movement after surgery, and complication rates. Despite a similar parenteral and oral analgesic requirement, the stapled group had a significantly better pain score (P = 0.002); these patients also had a significantly shorter length of stay (P = 0.02), and on average resumed work nine days earlier than the group treated with the Harmonic Scalpel (TM) (6.7 vs. 15.61 P = 0.002). Although 88 percent of doughnuts obtained in the stapled group contained some smooth muscle fibers, no association was found between smooth muscle incorporation and postoperative continence function, and as a whole the continence outcomes of the stapled group were similar to those after Harmonic Scalpel (TM) hemorrhoidectomy. Finally, at six-month follow-up, patients who underwent the stapled procedure had significantly better satisfaction scores (P = 0.001). CONCLUSION: Stapled hemorrhoidopexy is a safe and effective procedure for Grade III hemorrhoidal disease. Patients derive greater short-term benefits of reduced pain, shorter length of stay, and earlier resumption to work. Long-term follow-up is necessary to determine whether these initial results are lasting.
