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3%聚多卡醇泡沫硬化疗法与痔动脉结扎联合直肠肛管修复术治疗II-III度痔病的随机对照试验

3% polidocanol foam sclerotherapy versus hemorrhoidal artery ligation with recto anal repair in hemorrhoidal disease grades II-III: a randomized, pilot trial.

作者信息

Neves Sara, Falcão Daniela, Povo Ana, Castro-Poças Fernando, Oliveira Jorge, Salgueiro Paulo

机构信息

Instituto Ciências Biomédicas Abel Salazar.

Gastroenterology, Centro Hospitalar Universitário do Porto, Portugal.

出版信息

Rev Esp Enferm Dig. 2023 Mar;115(3):115-120. doi: 10.17235/reed.2022.8568/2022.

DOI:10.17235/reed.2022.8568/2022
PMID:35638762
Abstract

PURPOSE

Polidocanol foam sclerotherapy (SP) versus doppler-guided hemorrhoidal artery ligation with recto-anal repair (HAL-RAR) in the treatment of hemorrhoidal disease (HD) was analyzed.

METHODS

A prospective, randomized study including patients with HD grades II and III was performed. Participants were randomly assigned (1:1) into SP or HAL-RAR, during a recruitment period between September 2019 and February 2020. Therapeutic success (Sodergren's and bleeding scores) was the primary outcome. Other outcomes evaluated included complications and implication in the professional life. Efficacy and safety outcomes were evaluated during the 8 weeks after surgery or the final SP session.

RESULTS

Forty-six patients were allocated either to SP (n=22) or HAL-RAR (n=24). Most patients achieved therapeutic success (SP 100% vs. HAL-RAR 90.9%, p=0.131). Complete success was higher in the SP group (91.7% vs. 68.2%, p=0.045) and SP patients had less complications (25% vs. 68.2%, p=0.003). HAL-RAR had a greater negative impact on work activity of the patient.

CONCLUSION

SP was more effective and safer than HAL-RAR. SP patients had less impact on their work activity. Clinical trials identifier NCT04675177.

摘要

目的

分析聚多卡醇泡沫硬化疗法(SP)与多普勒引导下痔动脉结扎联合直肠肛管修复术(HAL-RAR)治疗痔病(HD)的效果。

方法

对II级和III级HD患者进行了一项前瞻性随机研究。在2019年9月至2020年2月的招募期间,参与者被随机(1:1)分配到SP组或HAL-RAR组。治疗成功(索德格伦评分和出血评分)是主要结局。评估的其他结局包括并发症和对职业生活的影响。在手术后或最后一次SP治疗后的8周内评估疗效和安全性结局。

结果

46例患者被分配到SP组(n=22)或HAL-RAR组(n=24)。大多数患者取得了治疗成功(SP组100% vs. HAL-RAR组90.9%,p=0.131)。SP组的完全成功率更高(91.7% vs. 68.2%,p=0.045),且SP组患者的并发症更少(25% vs. 68.2%,p=0.003)。HAL-RAR对患者的工作活动有更大的负面影响。

结论

SP比HAL-RAR更有效、更安全。接受SP治疗的患者对其工作活动的影响更小。临床试验标识符NCT04675177。

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