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临床试验/CTRI/2025/09/094931
CTRI/2025/09/094931尚未招募2 期

Comparison of postoperative wound drainage with and without use of fibrin sealant in patients undergoing total thyroidectomy- A Randomized Controlled Study.

Maulana Azad Medical College and Associated Lok Nayak Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Post operative drain output

研究概览

简要总结

This study is being done to evaluate the role of fibrin sealant in decreasing postoperative complications like seroma and hematoma formation in patients undergoing total thyroidectomy which in turn can lead to decreasing drain requirement and hospital stay aftr thyroid surgery. Multiple earlier studies have shown variable results and the use o fibrin sealant in thyroid surgeries is still under scrutiny. In this study, 4 ml of fibrin sealant will be sprayed in surgical bed and skin closed using standard technique. post operative drain output will be compared in the study and control group and total duration of drain requirement will be assessed. this study can provide a useful role of fibrin sealant in decreasing postoperative morbidity and hospital stay of thyroid patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing total thyroidectomy.

排除标准

  • Revision surgery.
  • Patients undergoing central and lateral neck dissection.
  • Pregnancy and lactation.
  • Coagulation disorders.
  • History of previous irradiation.
  • Extrathyroidal extension.

结局指标

主要结局

Post operative drain output

时间窗: At 24 hours post operatively. | Total output till drain removal.

次要结局

  • Duration of Hospital Stay.(POD0 to discharge)
  • Duration of drain requirement.
  • Incidence of hematoma formation.(42 days post operatively)
  • Incidence of surgical site infection.(42 days post operatively)

研究者

发起方
Maulana Azad Medical College and Associated Lok Nayak Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ashish Kumar

Maulana Azad Medical College Dr

研究点 (1)

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