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CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Stapled and open hemorrhoidectomy: randomized controlled trial of early results.
World Journal of Surgery 2003 Februrary
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.
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