Prospective single blinded -randomized study to evaluate the injury rate of the external laryngeal nerve in thyroid operations using two surgical technique.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- a) To analyze vocal function before and after thyroidetcomy for patients with normal preoperative voice using standard multidimensional voice assessment protocol.b) To assess whether the incidence of vocal dysfunction varies with two surgical techniques.
研究概览
简要总结
This is a randomized prospective single blinded two-arm study among patients scheduled to undergo primary thyroid surgery to see the influence of two standard surgical techniques in limiting the rate of external laryngeal nerve injury Patients who meet the inclusion criteria and who give consent for the study will be included in the study. All patients with normal voice will undergo preoperative functional voice assessment which will include the physician?s or speech therapist?s appraisal of voice. Changes of pitch range, intensity fatigability will be assessed during the interview. The degree of perceptual dysphonia will be graded using the standardized voice rating scale (GRBAS). Vocal function will further be assessed by a battery of acoustic and videostroboscopic tests as part of a standardized voice assessment protocol.Acoustic testing :The acoustic signals will be recorded using a unidirectional microphone maintained at a mouth-to-microphone distance of 30 cm. The signals will then be analyzed using ?Ling Waves? software. The parameters studied include voice range profile, maximum phonation time, fundamental frequency, jitter, shimmer and harmonics-to-noise ratio.Vocal fold imaging :Videostroboscopy will be performed with Storz videostroboscope. The images will be stored on a computer and subsequently evaluated to assess the symmetry of vocal fold vibration, amplitude and regularity of vocal fold movement and mucosal wave characteristics.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
入选标准
- •at least 15 years of age benign thyroid pathology or differentiated thyroid carcinoma no history of professional voice training no prior vocal pathology requiring therapy no previous thyroid or midline neck surgery.
排除标准
- •Previous midline neck or thyroid surgeryPrevious known operation in the larynxknown dysphonia vocal cord paralysishistory of speech disorderunable to sustain phonation of more than 10 secondshearing impairmentLocally advanced carcinoma thyroid especially when the superior pole in involved.
结局指标
主要结局
a) To analyze vocal function before and after thyroidetcomy for patients with normal preoperative voice using standard multidimensional voice assessment protocol.b) To assess whether the incidence of vocal dysfunction varies with two surgical techniques.
时间窗: 10 days and 3 months following surgey
次要结局
- To assess whether the incidence of Hypocalcaemia can be influenced by the two techniques(On the day one of the surgery and 7th day)