Effect of Oxidized Regenerated Cellulose on Voice Quality After Total Thyroidectomy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline in Jitter Percentage at Postoperative Day 21
研究概览
简要总结
This randomized controlled trial evaluated whether placement of oxidized regenerated cellulose (ORC) over the recurrent laryngeal nerves during total thyroidectomy affects early postoperative voice quality. Patients undergoing bilateral total thyroidectomy for benign or malignant thyroid disease were assigned in a 1:1 ratio to bilateral placement of ORC within the thyroid bed or to conventional hemostasis without ORC.
All participants underwent preoperative videolaryngostroboscopic examination and objective acoustic voice analysis. Acoustic assessment was repeated on postoperative day 21. The study evaluated changes in jitter, shimmer, normalized noise energy, harmonics-to-noise ratio, maximum phonation time, and the s/z ratio. Postoperative complications and adverse events potentially related to ORC were also recorded.
详细描述
This was a prospective, single-center, randomized, two-arm, parallel-group controlled trial involving patients undergoing bilateral total thyroidectomy for benign or malignant thyroid disease.
Before surgery, all participants underwent videolaryngostroboscopic examination to document normal vocal cord mobility and recurrent laryngeal nerve function. Objective acoustic voice analysis was also performed before surgery.
All operations were performed by the same experienced endocrine surgeon through a standard Kocher collar incision. Both recurrent laryngeal nerves and the parathyroid glands were routinely identified and preserved. Conventional hemostasis was achieved using bipolar cautery while avoiding thermal injury to the recurrent laryngeal nerves.
Immediately before completion of surgery, participants were randomized in a 1:1 ratio using a simple card-drawing method performed by an assistant. In the experimental group, a 1 × 2 cm piece of oxidized regenerated cellulose was placed bilaterally over the recurrent laryngeal nerves within the thyroid bed. In the control group, surgery was completed after conventional hemostasis without placement of oxidized regenerated cellulose.
Objective acoustic voice analysis was repeated on postoperative day 21 using 15-second voice recordings analyzed with Dr. Speech Real Analysis software. The assessed acoustic outcomes included jitter, shimmer, normalized noise energy, harmonics-to-noise ratio, maximum phonation time, and the s/z ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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 scheduled to undergo bilateral total thyroidectomy for benign or malignant thyroid disease.
- •Written informed consent for participation.
- •Normal preoperative vocal cord mobility and recurrent laryngeal nerve function documented by videolaryngostroboscopic examination.
排除标准
- •Previous thyroid surgery.
- •Previous parathyroid surgery.
- •Previous vocal cord surgery.
- •Previous laryngeal surgery.
- •Preoperative vocal cord paralysis.
- •Preoperative vocal cord polyp.
- •Any other preoperative laryngeal pathology considered likely to interfere with acoustic voice analysis.
结局指标
主要结局
Change From Baseline in Jitter Percentage at Postoperative Day 21
时间窗: Baseline to postoperative day 21
Jitter was calculated from a 15-second voice recording using Dr. Speech Real Analysis software and reported as a percentage. Change was calculated as the postoperative value minus the preoperative value.
Change From Baseline in Shimmer Percentage at Postoperative Day 21
时间窗: Baseline to postoperative day 21
Shimmer was calculated from a 15-second voice recording using Dr. Speech Real Analysis software and reported as a percentage. Change was calculated as the postoperative value minus the preoperative value.
Change From Baseline in Normalized Noise Energy at Postoperative Day 21
时间窗: Baseline to postoperative day 21
Normalized noise energy was measured using Dr. Speech Real Analysis software and reported in decibels. Change was calculated as the postoperative value minus the preoperative value.
Change From Baseline in Harmonics-to-Noise Ratio at Postoperative Day 21
时间窗: Baseline to postoperative day 21
The harmonics-to-noise ratio was measured using Dr. Speech Real Analysis software and reported in decibels. Change was calculated as the postoperative value minus the preoperative value.
Change From Baseline in Maximum Phonation Time at Postoperative Day 21
时间窗: Baseline to postoperative day 21
Maximum phonation time was measured in seconds during acoustic voice assessment. Change was calculated as the postoperative value minus the preoperative value.
Change From Baseline in the s/z Ratio at Postoperative Day 21
时间窗: Baseline to postoperative day 21
The s/z ratio was calculated by dividing the maximum duration of sustained /s/ phonation by the maximum duration of sustained /z/ phonation. Change was calculated as the postoperative value minus the preoperative value.
次要结局
- Number of Participants With Postoperative Surgical Complications(From surgery through postoperative day 21)
研究者
Volkan Genc
Professor of General Surgery
Ankara University