Prospective randomized multicentre trial comparing stapled with open haemorrhoidectomy

Abstract

The aim of this study was to compare the results of conventional open haemorrhoidectomy as currently practised in Italy (group 1) with stapled haemorrhoidectomy using a 33-mm circular stapling device (group 2). One hundred patients with symptomatic third- and fourth-degree haemorrhoids were enrolled by five hospitals. Patients were allocated to the two groups according to a centralized randomization scheme featuring five permutated blocks of 20. Preoperative clinical examination and anorectal manometry demonstrated no features of anal incontinence. Patients had a clinical and manometric re-evaluation after operation and were asked to complete a clinical diary. After a median of 16 (range 8-19) months patients were administered a standardized questionnaire by telephone. Postoperative bleeding requiring haemostatic procedures occurred in three patients in each group. Patients in group 1 complained of moderate pain for a median of 5.3 (range 0-19) days compared with 3.1 (range 0-10) days in group 2 (P = 0.01), while severe pain was present for 2.3 (range 0-24) days in group 1 but only for 1 (range 0-14) day in group 2 (P = 0.03). The median hospital stay was 2 days in group 1 compared with 1 day in group 2 (P = 0.01). In the early days after operation, patients in group 2 had greater difficulty in maintaining normal continence to liquid stools (P = 0.01), but after 30 days the continence score was better in group 2 (P = 0.04). Stapled haemorrhoidectomy is as effective as conventional haemorrhoidectomy. Reduced postoperative pain, shorter hospital stay and a trend toward earlier return to work suggest short-term advantages for the stapled technique.