NCT07241611已完成不适用
Role of Cervical Fascia Flap in Decreasing the Incidence of Pharyngocutaneous Fistula After Total Laryngectomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- incidence of pharyngocutaneous fistula after total laryngectomy
研究概览
简要总结
This study was conducted to evaluate the potential role of using the cervical fascia flap over the pharyngeal closure line to enhance healing and subsequently to decrease the incidence of pharyngocutaneous fistula 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 who will undergo total laryngectomy for advanced laryngeal carcinoma in the study duration.
排除标准
- •Presence of extra-laryngeal extension.
- •Patients undergoing partial pharyngectomy.
- •Previous neck irradiation.
- •Previous neck surgery.
- •Patients' refusal to participate in the study.
研究组 & 干预措施
conventional repair group
Active Comparator
干预措施: Total laryngectomy (Procedure)
cervical fascia flap group
Active Comparator
干预措施: Total laryngectomy (Procedure)
结局指标
主要结局
incidence of pharyngocutaneous fistula after total laryngectomy
时间窗: Four weeks
次要结局
- subjective assessment of the swallowing function after surgery(three months)
- objective assessment of the swallowing function after surgery(Three months)
研究者
研究点 (1)
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