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经鼻内窥镜下泪囊鼻腔吻合术中应用高压球囊导管行内路泪道疏通术: 一项随机对照试验

Endocanalicular, high-pressure balloon catheter, endoscopic dacryocystorhinostomy: a randomized controlled trial.

机构信息

Tanta University Hospitals, Tanta, Egypt.

出版信息

Otolaryngol Head Neck Surg. 2011 Oct;145(4):683-8. doi: 10.1177/0194599811410534. Epub 2011 May 25.

Abstract

OBJECTIVES

To conduct a prospective randomized controlled study to investigate the safety and efficacy of endocanalicular, high-pressure, 5-mm balloon catheter, endoscopic dacryocystorhinostomy (DCR) in adult patients with acquired complete nasolacrimal obstruction.

STUDY DESIGN

Prospective randomized controlled study.

SETTING

General hospital.

SUBJECTS AND METHODS

Sixty-six adult patients with a total of 70 procedures were recruited to undergo endoscopic DCR. They were prospectively, equally randomized into 2 groups: endocanalicular, high-pressure, 5-mm balloon catheter, endoscopic DCR (group I) and conventional endoscopic DCR (group II). Regular follow-up sessions were conducted to document the patient's subjective improvement, judge ostium patency on irrigation, and record any complications.

RESULTS

Both groups demonstrated a success rate of 91.4%. There was a shorter mean operative time (25.7 minutes) in group I (P < .001). The number of adverse events was significantly higher in group II (P < .05). Group I showed statistically significantly more comfort during surgery under local anesthesia with minimal sedation (P < .05).

CONCLUSION

Endocanalicular balloon catheter endoscopic DCR shares the advantages and success rate of conventional endoscopic DCR. In addition, the former is simpler, requires less manipulation, consumes a shorter operative time, has a better safety profile, and can be conducted under local anesthesia with minimal sedation.

摘要

目的

进行一项前瞻性随机对照研究,以评估经鼻内窥镜下球囊导管内切开术(endo-canalicular, high-pressure, 5-mm balloon catheter, endoscopic dacryocystorhinostomy,EBDC)治疗成人获得性完全鼻泪管阻塞的安全性和有效性。

研究设计

前瞻性随机对照研究。

设置

综合医院。

受试者和方法

共招募了 66 例成年患者(共 70 只眼)接受经鼻内窥镜下 EBDC。这些患者前瞻性地被平均随机分为两组:球囊导管内切开经鼻内窥镜下 DCR(组 I)和传统经鼻内窥镜下 DCR(组 II)。定期随访以记录患者的主观改善情况、判断冲洗时泪道通畅情况,并记录任何并发症。

结果

两组的成功率均为 91.4%。组 I 的平均手术时间较短(25.7 分钟)(P <.001)。组 II 的不良事件数量明显更高(P <.05)。在局部麻醉加轻微镇静下,组 I 术中舒适度明显更高(P <.05)。

结论

球囊导管内切开经鼻内窥镜下 DCR 具有与传统经鼻内窥镜下 DCR 相同的优势和成功率。此外,前者更简单、操作更少、手术时间更短、安全性更好,并且可以在局部麻醉加轻微镇静下进行。

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