Stapled and open hemorrhoidectomy: randomized controlled trial of early results.

The aim of the study was to compare the early results in 52 patients randomly allocated to undergo either stapled or open hemorrhoidectomy. Seventy-four patients with grade III and IV hemorrhoids were randomly allocated to undergo either stapled (37 patients) or open (37 patients) hemorrhoidectomy. Stapled hemorrhoidectomy was performed with the use of a circular stapling device. Open hemorrhoidectomy was accomplished according to the Milligan-Morgan technique. Postoperative pain was assessed by means of a visual analogue scale (V.A.S.). Recovery evaluation included return to pain-free defecation and normal activities. A 6-month clinical follow-up and a 17.5 (10 to 27)-month median telephone follow-up was obtained in all patients. Operation time for stapled hemorrhoidectomy was shorter (median 25 [range 15 to 49] minutes versus 30 [range 20 to 44] minutes, p = 0.041). Median (range) V.A.S. scores in the stapled group were significantly lower (V.A.S. score after 4 hours: 4 [2 to 6] versus 5 [2 to 8], p = 0.001; V.A.S. score after 24 hours: 3 [1 to 6] versus 5 [3 to 7], p = 0.000; V.A.S. score after first defecation: 5 [3 to 8] versus 7 [3 to 9], p = 0.000). Resumption of pain-free defecation was significantly faster in the stapled group (10 [6 to 14] days vs 12 [9 to 19] days, p = 0.001). At follow-up 4 weeks and 6 months postoperatively the median (range) symptom severity score was similar in both groups (1 [0 to 2] versus 0 [0 to 3], p = 0.150 and 0 [0 to 2] versus 0 [0 to 2], p = 0.731). At long-term follow-up occasional pain was present in 6/37 (16.2) patients in the stapled group and 7/37 (18.9%) in the Milligan-Morgan group (p = 1.000); episodes of bleeding were reported by 8/37 (21.6%) patients in the stapled group and 5/37 (13.5%) patients in the Milligan-Morgan group (p = 0.542). No problems related to continence and defecation were reported in either group. Patients were satisfied with the operation in 33/37 (89.2%) cases in the stapled group and 31/37 (83.8%) cases in the Milligan-Morgan group (p = 0.735). Hemorrhoidectomy with a circular staple device is easy to perform and achieves better results than the Milligan-Morgan technique in terms of postoperative pain and recovery. Comparable results are obtained at long-term follow-up.

RCT Entities:   Population Interventions Outcomes