Comparison of Effects of Energy Based Devices on Quality of Life After Sutureless Thyroidectomy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 主要终点
- Overall alterations in quality of life according to Thy-PRO-39 questionnaire
研究概览
简要总结
Patients underwent thyroidectomy filled an computer or paper based QoL questionnaire before and after operation.
详细描述
Patients who have consent to undergo to total thyroidectomy with sutureless technique (regardless of attending to study or not) for benign thyroid diseases in the institution are asked to participate to this study. Patients are informed that participating to this study will not alter their treatment method. Patients were operated either with Ligasure SmallJaw or Harmonic Focus according to result of label picked from bag. Same surgical team performed all operations and they did not know if the patient was participated in study or not.
Patients willing to participate in this study are being questioned for their quality of life (QoL) with a patient-reported outcome (PRO) questionnaire before surgery and 4 weeks after surgery. For assessment of quality of life Thy-PRO-39 questionnaire is being used. Responses of patients to QoL questionnaire is being recorded to a secure online database. After data completion answers of patients will be exported as anonymous to principal investigator for analysis. Effect of two energy based devices (EBD) on QOL will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Sutureless thyroidectomy for benign conditions
排除标准
- •Known neck malignity,
- •History of neck operation
- •Ligation use during surgery
- •Refusal of patient
- •Non-capable patient
- •Non-euthyroid patient
- •Pregnancy
- •Having rheumatic diseases
- •Having connective tissue diseases
结局指标
主要结局
Overall alterations in quality of life according to Thy-PRO-39 questionnaire
时间窗: 4 weeks
次要结局
- Alterations in social life according to Thy-PRO-39 questionnaire(4 weeks)
- Alterations in emotional susceptibility according to Thy-PRO-39 questionnaire(4 weeks)
- Alterations in daily life according to Thy-PRO-39 questionnaire(4 weeks)
- Alterations in cognitive complaints according to Thy-PRO-39 questionnaire(4 weeks)
- Alterations in anxiety according to Thy-PRO-39 questionnaire(4 weeks)
- Alterations in depressivity according to Thy-PRO-39 questionnaire(4 weeks)
- Alterations in Tiredness according to Thy-PRO-39 questionnaire(4 weeks)