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射频消融与电灼盲法随机对照试验:对临床有意义结局的影响。

Radiofrequency Ablation vs Electrocautery Blinded Randomized Trial: Impact on Clinically Meaningful Outcomes.

机构信息

Division of Otolaryngology, University of Utah Health, Salt Lake City, Utah, USA.

Department of Surgery, University of Utah Health, Salt Lake City, Utah, USA.

出版信息

Otolaryngol Head Neck Surg. 2021 Jun;164(6):1186-1192. doi: 10.1177/0194599820964737. Epub 2020 Oct 20.

DOI:10.1177/0194599820964737
PMID:33079009
Abstract

OBJECTIVE

To analyze patients' return to normal activity, pain scores, narcotic use, and adverse events after undergoing tonsillectomy or adenotonsillectomy with monopolar electrocautery or radiofrequency ablation.

STUDY DESIGN

Randomized double-blinded clinical trial based on prospective parallel design.

SETTING

Academic medical center and tertiary children's hospital between March 2018 and July 2019.

METHODS

Inclusion criteria included patients aged ≥3 years with surgical indication of recurrent tonsillitis or airway obstruction/sleep-disordered breathing. Patients were randomly assigned to monopolar electrocautery or radiofrequency ablation. Patients were blinded to treatment assignment. Survey questions answered via text or email were collected daily until postoperative day 15. The primary outcome was the patient's return to normal activity. Secondary outcomes included daily pain score, total amount of postoperative narcotic use, and adverse events.

RESULTS

Of the 236 patients who met inclusion criteria and were randomly assigned to radiofrequency ablation or monopolar electrocautery, 230 completed the study (radiofrequency ablation, n = 112; monopolar electrocautery, n = 118). There was no statistically significant difference between the groups in the number of days for return to normal activity ( = .89), daily pain scores over 15 postoperative days ( = .46), postoperative narcotic use ( = .61), or return to hospital for any reason ( = .60), including bleeding as an adverse event ( = .13).

CONCLUSIONS

As one of the largest randomized controlled trials examining instrumentation in tonsillectomy, our data do not show a difference between monopolar electrocautery and radiofrequency ablation with regard to return to normal activity, daily pain scores, total postoperative narcotic use, or adverse events.

摘要

目的

分析行扁桃体切除术或扁桃体腺样体切除术时采用单极电切或射频消融术的患者术后恢复正常活动、疼痛评分、使用麻醉性镇痛药和不良事件的情况。

研究设计

基于前瞻性平行设计的随机双盲临床试验。

设置

2018 年 3 月至 2019 年 7 月间的学术医疗中心和三级儿童医院。

方法

纳入标准为年龄≥3 岁、有反复发作性扁桃体炎或气道梗阻/睡眠呼吸障碍手术指征的患者。患者被随机分配至单极电切或射频消融组。患者对治疗分组设盲。通过短信或电子邮件回答每日调查问题,直至术后第 15 天。主要结局是患者恢复正常活动的时间。次要结局包括每日疼痛评分、术后麻醉性镇痛药总用量和不良事件。

结果

在符合纳入标准并被随机分配至射频消融或单极电切的 236 例患者中,有 230 例完成了研究(射频消融组,n=112;单极电切组,n=118)。两组患者恢复正常活动的天数( =.89)、术后 15 天内的每日疼痛评分( =.46)、术后麻醉性镇痛药用量( =.61)或因任何原因(包括出血在内的不良事件)返回医院的情况( =.60)均无统计学差异。

结论

作为一项检查扁桃体切除术器械的最大规模随机对照试验之一,我们的数据并未显示单极电切与射频消融在恢复正常活动、每日疼痛评分、总术后麻醉性镇痛药用量或不良事件方面存在差异。

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引用本文的文献

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Int Arch Otorhinolaryngol. 2023 Mar 29;27(4):e694-e698. doi: 10.1055/s-0042-1758715. eCollection 2023 Oct.
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Analysis on the Effect of Radiofrequency Ablation and Electrocautery in the Treatment of Vaginal Intraepithelial Neoplasia.射频消融术与电灼术治疗阴道上皮内瘤变的疗效分析
J Oncol. 2023 Feb 6;2023:9432073. doi: 10.1155/2023/9432073. eCollection 2023.
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Comparative systematic review and meta-analysis of the therapeutic effects of coblation tonsillectomy versus electrocautery tonsillectomy.
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