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局部麻醉与全身麻醉下日间痔开放切除术的随机临床试验

Randomized clinical trial comparing day-care open haemorrhoidectomy under local versus general anaesthesia.

作者信息

Kushwaha R, Hutchings W, Davies C, Rao N G

机构信息

Channel Day Surgery Unit, William Harvey Hospital, Ashford TN24 0LZ, UK.

出版信息

Br J Surg. 2008 May;95(5):555-63. doi: 10.1002/bjs.6113.

Abstract

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).

摘要

背景

局部麻醉下日间痔切除术(LH)可能是痔切除术最具成本效益的方法。这项前瞻性随机试验从患者和临床角度比较了LH与全身麻醉下日间痔切除术(GH)后的结果。

方法

41例三度痔患者被随机分为LH组(19例)或GH组(22例)。患者人口统计学特征具有可比性。15例患者切除单个痔,13例患者分别切除两个和三个痔。由独立护士主导进行评估和临床评价,为期6个月。观察指标为术后30、60和90分钟时的平均疼痛评分和预期疼痛评分,随后10天每天记录,以及术后10天、6周和6个月时的满意度评分。次要观察指标为日间手术单元内的停留时间和总成本。

结果

术后90分钟时,LH组疼痛比GH组更严重(P = 0.028),但回家时的疼痛评分相似。LH组术后第3天疼痛最剧烈,GH组术后第6天疼痛最剧烈。从术后第1天起,LH组的每日疼痛评分较低,第8天有显著差异(LH组平均(95%置信区间)为3.61(2.74至4.48),GH组为5.29(4.12至6.45);P = 0.027)。两组10天内的平均疼痛、预期和满意度评分相似。LH组的停留时间较短,费用低于GH组。

结论

LH与GH具有相似的耐受性和临床结果,且停留时间较短、成本较低。

注册号

NCT00503269(http://www.clinicaltrials.gov)

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