Does a more extensive mucosal excision prevent haemorrhoidal recurrence after stapled haemorrhoidopexy? Long-term outcome of a randomized controlled trial.

Abstract

The study aimed in a multicentric randomized controlled trial to define the role of a more extensive mucosal resection on recurrence of mucosal prolapse in patients with Stage III haemorrhoids undergoing stapled haemorrhoidopexy. In all, 135 patients were randomized to treatment with a PPH-01/03 (Ethicon EndoSurgery) or an EEA (Covidien) stapler. They were reviewed after a minimum follow-up of 4years to determine the rate of recurrent mucosal prolapse and general condition (wellness evaluation score). Postoperative bowel dysfunction was assessed using the Rome III criteria. Eighty-seven (65%) of the 135 patients (48 in the EEA stapler group and 37 in the PPH group) were available for long-term follow-up. The two groups were comparable for age, gender and duration of follow-up (mean 49.3±5.4months and 49.0±5.3months respectively). In the EEA group, 11 (23%) patients had some degree of recurrent prolapse compared with 12 (32%) in the PPH group (P=0.409). Persistence of anal bleeding was significantly higher in the PPH group (P=0.04) while the postoperative Haemorrhoid Symptom Score was significantly better in the EEA group (1.73±1.65 vs 3.17±1.94, P<0.001). The wellness evaluation score was significantly better in the EEA group (1.2±1.27 vs 0.6±1.0, P=0.028). Furthermore, 7 (15%) of the patients in the EEA group complained of some evacuation disturbance compared with 13 (36%) in the PPH group (P=0.021). The study failed to demonstrate any significant difference in the long-term recurrence rate of Stage III haemorrhoids using EEA or PPH. Nevertheless, use of the larger volume EEA provides better symptom resolution compared with PPH.