Evaluation of Functional Results After Surgery of Oropharyngeal Cancers With Soft Palate With Free Flap Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Evaluation of phonation quality at least 12 months after the end of external radiotherapy.
研究概览
简要总结
The oropharynx is a complex anatomical structure necessary for nasal breathing, swallowing and phonation. The removal of oropharyngeal cancers can lead to sequelae, particularly in the case of resections affecting the soft palate. The main sequelae are represented by rhinolalia and swallowing disorders with nasal regurgitation.
The treatment of oropharyngeal tumors is based on primary surgery or radiotherapy, but tumors of the soft palate are often treated by radiotherapy or radio-chemotherapy first. Surgery is often kept for relapses, because it is considered to lead to important sequelae. However, chemoradiotherapy of the oropharynx is also responsible for acute toxicities, and late sequelae can be frequent and important.
Recent publications tend to show that primary surgery would give better survival rates compared to radiotherapy, particularly in advanced stages, including viro-induced cancers. In addition, primary surgery can reduce the dose of radiation delivered to the oropharynx and thus reduce its long-term toxicity.
It is currently possible to reconstruct a loss of substance after surgery of oropharyngeal cancers, including the soft palate by using free flaps, limiting the postoperative sequelae usually observed without reconstruction.
There is little data on reconstructions of the soft palate, their sequelae and their impact on the quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with oropharyngeal tumor who had surgical management with removal of all or part of the soft palate and free flap reconstruction, and at least 12 month after the end of external radiotherapy treatment
- •Patients over 18 years old
排除标准
- •Patients protected by law (guardianship, curatorship and under judicial protection)
- •Patients who expressed their opposition to participate to the study
- •Patients who do not speak French (incompatible with reading, understanding and filling out the questionnaires)
- •Patients participating in interventional research (excluding physiological studies and interventional research with minimal risks and constraints that do not interfere with the primary endpoint analysis)
结局指标
主要结局
Evaluation of phonation quality at least 12 months after the end of external radiotherapy.
时间窗: 12 months
Self-evaluation by completion of the Voice Handicap Index questionnaire, in its 30 items version. For self evaluation of phonation using the Voice Handicap Index 30 (VHI 30) questionnaire: The VHI is rated on 120 points. For each question a score from 0 to 4 is assigned (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always). Its three sub-scales allow to establish an emotional score E out of 40, a physical score P out of 40 and a Functional score F out of 40. The total score can therefore be between 0 and 120 points. The interpretation of this test is done by comparing the sub-scores and the total score obtained with the averages values of these sub-scores and total score.
次要结局
- Hetero evaluation of phonation quality at least 12 months after the end of external radiotherapy(12 months)