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临床试验/CTRI/2025/07/091546
CTRI/2025/07/091546尚未招募不适用

Comparison of Patient Reported Outcome Measures(PROM)in Trans-oral Robotic Thyroidectomy(TORT) and Bilateral Axillo-Breast Approach Robotic Thyroidectomy (BABA-RT) for benign and intermediate thyroid lesions- A Randomized Control Trial

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年8月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
1.To compare the Patient Reported Outcome Measures (PROM) in surgeries, TORT vs BABA-

研究概览

简要总结

Traditional open thyroidectomy often results in visible neck scars and increased postoperative discomfort. Endoscopic approaches improve cosmesis but are limited by instrument mobility. Robotic techniques overcome these limitations with enhanced precision, 3D vision, and better ergonomics. By comparing two scarless robotic techniques, this study aims to identify which approach offers superior outcomes in terms of pain, cosmesis, voice, and quality of life. The findings will guide surgeons in selecting optimal techniques and support patient-centered, minimally invasive thyroid surgery practices based on robust clinical evidence. This study will help in determining which robotic approach is better for patients to have a good quality of life postoperatively. This study will help in defining the procedure which causses less cpmplications and more ease of doing.

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 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Benign or cytologically indeterminate lesions involving single lobe of size less than 4cm or 40ml.

排除标准

  • 1.Refusal to give consent 2.Patients not fit for general anaesthesia/ neck extension required for surgical positioning 3.History of head and neck surgery and previous irradiation 4.All thyroid lesions of size more than 4 cm or 40ml •All malignant lesions of thyroid •Evidence of active clinical hyperthyroidism or thyroiditis •Substernal thyroidal extension of swelling.

结局指标

主要结局

1.To compare the Patient Reported Outcome Measures (PROM) in surgeries, TORT vs BABA-

时间窗: After surgery

RT for benign and indeterminate thyroid swellings

时间窗: After surgery

次要结局

  • 1.To study for safety to compare the outcomes of TORT & BABART in terms of recurrent laryngeal nerve injury, parathyroid injury, blood loss, pain, respiratory distress, subcutaneous ecchymosis & paresthesia over neck, chin & chest.(2.To compare the TORT with BABA RT in terms of operating time)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anita

AIIMS New Delhi

研究点 (1)

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