NCT06256263已完成不适用
Linear Stapler Versus Conventional Repair of the Pharynx After Total Laryngectomy: Functional and Oncological Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- incidence of pharyngocutaneous fistula after total laryngectomy
研究概览
简要总结
This study was done to investigate the efficacy and safety of the linear stapler closure of the pharynx after total laryngectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients undergoing total laryngectomy for advanced laryngeal carcinoma in the study duration .
排除标准
- •Infiltration of the safety margins proved by postoperative histopathology .
- •Patients with tumor extension to the tongue base, or the hypopharynx .
- •Patients who are unfit for surgery .
- •Patients refusal to surgical treatment
结局指标
主要结局
incidence of pharyngocutaneous fistula after total laryngectomy
时间窗: four weeks
to assess the effectiveness of pharyngeal repair and healing without pharyngocutaneous fistula
次要结局
- assessment of the swallowing function after surgery(6 months)
研究者
研究点 (2)
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