Postoperative Swallowing and Voice Outcomes After Collagen Matrix Reconstruction in Oral and Oropharyngeal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Swallowing evaluation
研究概览
简要总结
This study tend to evaluate postoperative phonation and swallowing after oncologic surgery of the oral cavity or oropharynx with application of a collagen matrix (Tachosil®). Patients are asked to complete a questionnaire the day before the surgery and at 1 and 6 months after.
详细描述
It was an interventional study with a single Group.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Histologically confirmed squamous cell carcinoma or other malignant tumor of the oral cavity and/or oropharynx
- •Performance status (PS) 0-2
- •Tumor stages for which surgical resection was indicated (T1-T3)
- •Patients receiving or not receiving postoperative adjuvant radiotherapy
排除标准
- •Legal incapacity or limited legal capacity
- •Inability or anticipated poor compliance with study procedures
- •Missing questionnaire data
- •Congenital or acquired swallowing disorders (neurological or neuromuscular disease)
- •Congenital or acquired speech disorders (neurological or neuromuscular disease)
- •Death during the study period
研究组 & 干预措施
Case group
Patient were ≥18 years with a histologically confirmed squamous cell carcinoma or other malignant tumor of the oral cavity and/or oropharynx with surgical resection indicated (T1-T3). The performance status was betwen 0 and 2. Patients were receiving or not receiving postoperative adjuvant radiotherapy
结局指标
主要结局
Swallowing evaluation
时间窗: From enrollment (the day before the surgery) to 6 months postoperatively.
We use the Deglutition Handicap Index questionnaire to evaluative swallowing before and after surgery. Patients completed the questionnaires the day before surgery, and at 1 month and 6 months postoperatively.
Voice evaluation
时间窗: From enrollment (the day before the surgery) to 6 months postoperatively.
We use the Voice Handicap Index questionnaire to evaluate the phonatione before and after surgery. Patients completed the questionnaires the day before surgery, and at 1 month and 6 months postoperatively.
次要结局
- Length of hospital stay(From the day before the surgery up to 3 weeks after surgery. The number of days between hospital admission and discharge to home was calculated.)
- time to oral feeding resumption(From the surgery up to two weeks.)
- incidence and onset of device-related complications(From the day of the surgery to one week after)
研究者
SAYAH Charline
Dr SAYAH Charline
Hôpital de la Croix-Rousse