CTRI/2026/02/103063尚未招募不适用
Low cost nerve stimulator to reduce shoulder morbidity due to neck dissection in head and neck cancer a randomized controlled trial
Dr Ankur1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年3月5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
- 70
- 试验地点
- 1
研究概览
简要总结
The primary purpose of this study is to determine whether the routine intraoperative use of a low-cost handheld nerve stimulator during neck dissection reduces postoperative spinal accessory nerve–related shoulder dysfunction compared with standard visual nerve identification alone. The study hypothesizes that intraoperative nerve stimulation with observation of muscle contraction will improve identification and preservation of the spinal accessory nerve, thereby resulting in significantly better postoperative shoulder function and electrophysiological nerve outcomes than conventional surgery without stimulation.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with head and neck malignancies requiring unilateral or bilateral, selective or modified radical neck dissection involving levels II, and/or V (example, oral cavity SCC, thyroid carcinoma etc) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Ability to provide written informed consent.
- •Ability to understand and cooperate with clinical examinations and Electromyography study.
排除标准
- •Patients with pre-existing dysfunction of the shoulder/SAN on the side(s) of planned neck dissection, as determined by preoperative clinical assessment and/or EMG.
- •More than 3cm node or with extranodal extension or clinically fixed level II and V Previous neck dissection or surgery in the neck levels involving the Spinal Accessory, as this can significantly alter anatomy and baseline nerve function.
- •Prior radiotherapy to the neck involving the planned dissection levels, which can affect nerve health and recovery independently of surgical manipulation.
- •Known neuromuscular disorders (e.g., Myasthenia Gravis, ALS, peripheral neuropathy not related to HNC or its treatment) that could affect the targeted nerves or muscles Patients with cognitive impairment precluding cooperation with clinical assessment or providing informed consent.
研究者
Dr Ankur
AIIMS Mangalagiri
研究点 (1)
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