A Prospective Randomized Controlled Study of Whether Anti-adhesion Barrier Can Prevent Voice Quality After Thyroidectomy.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Voice Handicap Index - 30 (VHI-30)
研究概览
简要总结
To determine whether the use of anti-adhesion barrier after thyroid surgery can prevent the voice changes after surgery, using objective voice-related indicators.
详细描述
- Randomized controlled study
- Including 40 patients in each arm
- Treatment: anti-adhesion barrier apply on the thyroidectomy space
- Control: No use of anti-adhesion barrier
- Primary outcome: VHI-30 (Voice handicap index)
- Secondary outcome: findings from stroboscopy, CSL (Computerize Speech Lab)
- Outcome measurement: preoperative, post-operative 3 months, post-operative 9 months.
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
- Single (Participant)
盲法说明
Participants do not know about the use of anti-adhesion agents.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing open thyroidectomy for thyroid cancer
- •Patients whose tumor size is less than 4cm
- •Patients who are not suspected of surrounding organ involvement (T4) or metastasis to central lymph nodes in preoperative imaging
- •Patients with no history of voice-related diseases prior to surgery
- •Patients with normal movement of both vocal cords in the preoperative vocal cord examination
- •Patients who consented to the study and obtained consent for the study
排除标准
- •Patients with uncontrolled high blood pressure, diabetes, chronic renal failure, coagulation disease, etc.
- •History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.)
- •Medical history of drug or substance disorder (alcohol, etc.)
- •Patients with diseases related to airways, esophagus, and vocal cords (vocal palsy, vocal cord polyps, etc.)
- •Patients who have already had adhesions in the foreground due to radiation therapy or surgery on the foreground in the past.
- •Patients with a history of keloid or hypertrophic scars
- •Patients planning to perform lateral cervical lymph node dissection
- •Patients with medical thyroid disease, such as Graves' disease and thyroid inflammation in need of treatment
- •Pregnant or lactating female patients
- •Other patients who are in charge of clinical trials as unsuitable for participation in the study
研究组 & 干预措施
Treatment
Use of Anti-adhesion barrier on the thyroidectomy space. After the thyroidectomy, anti-adhesion barrier will be applied on the thyroidectomy space, around the trachea, cricothyroid muscle and platysma muscle before the closure of surgical wound.
干预措施: Anti-adhesion barrier (Collarbarrier) (Device)
Control
No use of anti-adhesion barrier. After the thyroidectomy, don't use the anti-adhesion barrier before the wound closure.
结局指标
主要结局
Voice Handicap Index - 30 (VHI-30)
时间窗: Postoperative 9 months
Overall score of VHI (Total 30 points)
Voice Handicap Index - 30 (VHI-30)
时间窗: Preoperative 1 day
Overall score of VHI (Total 30 points)
Voice Handicap Index - 30 (VHI-30)
时间窗: Postoperative 3 months
Overall score of VHI (Total 30 points)
次要结局
- GRBAS score(Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.)
- Voice range profile (VRP)(Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.)
研究者
Jin Wook Yi
Assistant Professor
Inha University Hospital