BACKGROUND: Day-care open haemorrhoidectomy under local anaesthesia (LH) may be the most cost-effective approach to haemorrhoidectomy. This prospective randomized trial compared outcome after LH from patients' and clinical perspectives with that after day-care open haemorrhoidectomy under general anaesthesia (GH). METHODS:Forty-one patients with third-degree haemorrhoids were randomized to LH (19) or GH (22). Patient demographics were comparable. A single haemorrhoid was excised in 15 patients, and two and three haemorrhoids in 13 each. Independent nurse-led assessment and clinical evaluation were carried out for 6 months. Outcome measures were mean and expected pain scores at 30, 60 and 90 min, then daily for 10 days, and satisfaction scores at 10 days, 6 weeks and 6 months. Secondary outcomes were journey time within the day-surgery unit and overall cost. RESULTS:Pain was worse following LH than GH at 90 min after surgery (P = 0.028), but pain scores on reaching home were similar. Maximum pain was experienced on day 3 after LH and on day 6 after GH. From day 1 onwards, daily pain scores were lower in the LH group, and there was a significant difference on day 8 (mean (95 per cent confidence interval) 3.61 (2.74 to 4.48) for LH versus 5.29 (4.12 to 6.45) for GH; P = 0.027). Mean pain over 10 days, expectation and satisfaction scores were similar in the two groups. LH had a shorter journey time and was less expensive than GH. CONCLUSION:LH has similar tolerance and clinical outcome to GH, and is associated with a shorter journey time and lower cost. REGISTRATION NUMBER: NCT00503269 (http://www.clinicaltrials.gov). 2008 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
RCT Entities:
BACKGROUND: Day-care open haemorrhoidectomy under local anaesthesia (LH) may be the most cost-effective approach to haemorrhoidectomy. This prospective randomized trial compared outcome after LH from patients' and clinical perspectives with that after day-care open haemorrhoidectomy under general anaesthesia (GH). METHODS: Forty-one patients with third-degree haemorrhoids were randomized to LH (19) or GH (22). Patient demographics were comparable. A single haemorrhoid was excised in 15 patients, and two and three haemorrhoids in 13 each. Independent nurse-led assessment and clinical evaluation were carried out for 6 months. Outcome measures were mean and expected pain scores at 30, 60 and 90 min, then daily for 10 days, and satisfaction scores at 10 days, 6 weeks and 6 months. Secondary outcomes were journey time within the day-surgery unit and overall cost. RESULTS:Pain was worse following LH than GH at 90 min after surgery (P = 0.028), but pain scores on reaching home were similar. Maximum pain was experienced on day 3 after LH and on day 6 after GH. From day 1 onwards, daily pain scores were lower in the LH group, and there was a significant difference on day 8 (mean (95 per cent confidence interval) 3.61 (2.74 to 4.48) for LH versus 5.29 (4.12 to 6.45) for GH; P = 0.027). Mean pain over 10 days, expectation and satisfaction scores were similar in the two groups. LH had a shorter journey time and was less expensive than GH. CONCLUSION:LH has similar tolerance and clinical outcome to GH, and is associated with a shorter journey time and lower cost. REGISTRATION NUMBER: NCT00503269 (http://www.clinicaltrials.gov). 2008 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
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