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临床试验/CTRI/2024/06/068599
CTRI/2024/06/068599尚未招募Phase 3 4

Comparing the efficacy of 3% NACL with pressure dressing and oral/rt glycopyrrolate with pressure dressing in the treatment of parotid sialocele, in postoperative oral squamous cell carcinoma patient- a randomised control trial

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年7月25日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
The superior efficacy of 3% NaCl

研究概览

简要总结

Background: Parotid sialocele is a common complication following surgical treatment 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. Objective: 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. 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, Length of time required for resolution of salivary sialocele, wound dehiscence, length of post operative stay, amount of time to resumption of oral feeds and the timing of postoperative adjuvant therapy. . Expected outcome-The study anticipates demonstrating the superior efficacy of 3% NaCl with pressure dressing over oral glycopyrrolate with pressure dressing in resolving parotid sialocele among postoperative oral squamous cell carcinoma (OSCC) patients. These findings will guide evidence-based treatment approaches, enhancing patient care and outcomes for this prevalent complication. Conclusion: This randomized controlled trial will provide valuable 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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients operated for Oral squamous Cell carcinoma(buccal and GB sulcus) with resection of tail of Parotid followed by Reconstruction using suitable flap.
  • Patients with excessive salivation postoperatively in patients operated for Oral squamous cell carcinoma.

排除标准

  • Systemic or autoimmune diseases affecting the salivary glands
  • Patients with any salivary gland neoplasms or inflammatory disorders.
  • Patients that have been previously operated for Oral squamous cell carcinoma.
  • Patients presenting with Recurrence of Oral squamous cell carcinoma.
  • Patients with traumatic injuries to the salivary gland region.

结局指标

主要结局

The superior efficacy of 3% NaCl

时间窗: Assesment will be done at the 12 and 24 months

with pressure dressing over oral glycopyrrolate with pressure dressing in resolving parotid

时间窗: Assesment will be done at the 12 and 24 months

sialocele among postoperative oral squamous cell carcinoma (OSCC) patients.

时间窗: Assesment will be done at the 12 and 24 months

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Jayesh phalak

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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