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比较3%氯化钠联合加压包扎与格隆溴铵口服联合加压包扎治疗口腔鳞状细胞癌术后腮腺涎瘘的疗效:一项随机对照试验的研究方案

Comparing the Efficacy of 3% NaCl With Pressure Dressing and Oral Glycopyrrolate With Pressure Dressing in the Treatment of Parotid Sialocele in Postoperative Oral Squamous Cell Carcinoma Patients: Study Protocol of a Randomized Controlled Trial.

作者信息

Phalak Jayesh, Shukla Deepankar, Bhola Nitin

机构信息

Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education and Research, Wardha, IND.

出版信息

Cureus. 2024 Jul 24;16(7):e65237. doi: 10.7759/cureus.65237. eCollection 2024 Jul.

Abstract

Introduction Parotid sialocele is a common complication following surgery for oral squamous cell carcinoma (OSCC), leading to discomfort and potential complications. Various treatment modalities have been proposed, including 3% NaCl with pressure dressing and oral glycopyrrolate with pressure dressing, yet evidence comparing their efficacy is limited. This randomized controlled trial aims to compare the efficacy of 3% NaCl with pressure dressing and oral glycopyrrolate with pressure dressing in the treatment of parotid sialocele among postoperative OSCC patients undergoing neck dissection. Material and methods Patients diagnosed with OSCC undergoing surgical intervention resulting in parotid sialocele will be randomly assigned to receive either 3% NaCl with pressure dressing or oral glycopyrrolate with pressure dressing. Treatment efficacy will be assessed based on the discharge of any serous collection from the suture line, the length of time required for resolution of salivary sialocele, wound dehiscence, the length of the postoperative stay, the amount of time to resume oral feeds, and the timing of postoperative adjuvant therapy. Results This is an ongoing study protocol, and we are expecting the analysis of the results in 2026. Conclusion This randomized controlled trial will furnish invaluable insights into the comparative efficacy of 3% NaCl with pressure dressing and oral glycopyrrolate with pressure dressing in the treatment of parotid sialocele among postoperative OSCC patients. The findings will inform evidence-based decision-making and optimize treatment strategies for this common complication.

摘要

引言

腮腺涎囊肿是口腔鳞状细胞癌(OSCC)手术后的常见并发症,会导致不适并引发潜在并发症。已提出多种治疗方式,包括3%氯化钠加压力敷料和口服格隆溴铵加压力敷料,但比较它们疗效的证据有限。这项随机对照试验旨在比较3%氯化钠加压力敷料和口服格隆溴铵加压力敷料在接受颈部清扫术的OSCC术后患者中治疗腮腺涎囊肿的疗效。

材料与方法

被诊断为OSCC并接受手术干预导致腮腺涎囊肿的患者将被随机分配接受3%氯化钠加压力敷料或口服格隆溴铵加压力敷料治疗。治疗效果将根据缝线处浆液性渗出物的排出情况、涎囊肿消退所需时间、伤口裂开情况、术后住院时间、恢复经口进食的时间以及术后辅助治疗的时间来评估。

结果

这是一项正在进行的研究方案,我们预计在2026年分析结果。

结论

这项随机对照试验将为3%氯化钠加压力敷料和口服格隆溴铵加压力敷料在OSCC术后患者中治疗腮腺涎囊肿的比较疗效提供宝贵见解。研究结果将为基于证据的决策提供依据,并优化针对这种常见并发症的治疗策略。

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