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量子分子共振手术刀与传统手术刀治疗唇部黏液囊肿的对比:一项双中心随机对照试验

Quantic molecular resonance scalpel vs traditional scalpel in the treatment of labial mucocele: a two-center randomized controlled trial.

作者信息

Broccoletti Roberto, Arduino Paolo G, Vescovi Paolo, Mergoni Giovanni, Mattiuzzi Monica, Merigo Elisabetta, DiLupo Mauro, Manfredi Maddalena

出版信息

Quintessence Int. 2014 Apr;45(4):331-8. doi: 10.3290/j.qi.a31332.

DOI:10.3290/j.qi.a31332
PMID:24459677
Abstract

OBJECTIVE

The aim of this randomized two-center study was to compare quantic molecular resonance scalpel (QMRS) with traditional scalpel (TS) for the surgical treatment of labial mucoceles, in terms of impact on quality of life and postoperative pain (primary outcomes) and postsurgical lip paresthesia and recurrence of the lesion (secondary outcomes).

METHOD AND MATERIALS

Eighty-five consecutive patients with labial mucoceles were randomized to receive traditional (46) or QMRS surgery (39) in two Italian University Hospital Centers. Patients were asked to complete three different forms during the first week after surgery to evaluate quality of life and postoperative pain. Periodic follow-up examinations were conducted at 1 week, 1 month, and 3 months after surgery, in order to detect recurrence of lesion and/or lip paresthesia.

RESULTS

Regarding the symptoms reported during the first week after surgery, questionnaires given to the patients and the mean painkiller consumption did not demonstrate any statistically significant differences within the two groups. Women treated with QMRS reported a worse experience than women treated with TS (P < .05). Among all the mucoceles treated, during the follow-up period of 3 months, one that had been eliminated with the cold scalpel was seen to relapse, versus none of those treated with the QMRS (P = 1.0). We reported a localized and terminal paresthesia of the labial mucosa close to the surgical site in 10.58% of the total patients. Comparing the QMRS with TS, we observed a greater incidence of neurologic complications with the latter technique (P = .035).

CONCLUSION

This is the first prospective randomized study to report outcome data and 3-month follow-up of a cohort of patients suffering from labial mucoceles. QMRS for surgical removal of labial mucoceles seems to be comparable to traditional scalpel in terms of postoperative quality of life, pain, and postsurgical lip paresthesia.

摘要

目的

这项随机双中心研究旨在比较量子分子共振手术刀(QMRS)与传统手术刀(TS)在唇黏液囊肿手术治疗中对生活质量和术后疼痛(主要结局)以及术后唇部感觉异常和病变复发(次要结局)的影响。

方法与材料

85例连续的唇黏液囊肿患者在两个意大利大学医院中心被随机分配接受传统手术(46例)或QMRS手术(39例)。患者在术后第一周被要求填写三种不同的表格以评估生活质量和术后疼痛。在术后1周、1个月和3个月进行定期随访检查,以检测病变复发和/或唇部感觉异常。

结果

关于术后第一周报告的症状,给予患者的问卷和平均止痛药消耗量在两组之间未显示出任何统计学上的显著差异。接受QMRS治疗的女性报告的体验比接受TS治疗的女性更差(P < .05)。在所有接受治疗的黏液囊肿中,在3个月的随访期内,1例接受冷手术刀切除的囊肿复发,而接受QMRS治疗的囊肿无一复发(P = 1.0)。我们报告在所有患者中有10.58%出现手术部位附近唇部黏膜的局限性终末感觉异常。将QMRS与TS进行比较,我们观察到后一种技术的神经并发症发生率更高(P = .035)。

结论

这是第一项前瞻性随机研究,报告了一组唇黏液囊肿患者的结局数据和3个月随访情况。QMRS用于手术切除唇黏液囊肿在术后生活质量、疼痛和术后唇部感觉异常方面似乎与传统手术刀相当。

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