A Randomized Controlled Trial Comparing The Cosmetic Outcome Of Electrocautery Versus Scalpel For Thyroidectomy Incisions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Appearance of surgical scar
研究概览
简要总结
This study looks at the difference in surgical scar outcomes between two different surgical incision methods during thyroid surgery: scalpel vs electrocautery. Patients who are already scheduled for thyroid surgery with Dr. Sam Wiseman, Endocrine Surgeon at St. Paul's Hospital, and that meet the eligibility criteria for this study will be invited to participate. After signing the informed consent form, participants will be randomized into either one of the two incision methods, but will not know which one they receive. There will be two follow-up time points: one at 6 and another at 12 months post-operative. At these time points the research team will send a letter to the participant asking them to rate the appearance of their surgical scar. They will also be asked to take a picture of their scar and send it back to the research team, so that the research team can make an assessment of their surgical scar. The study concludes when the 12 month follow-up is complete.
详细描述
Purpose:
To evaluates the difference in thyroid cosmesis between two different surgical incision methods during thyroidectomy: scalpel vs electrocautery.
Hypotheses:
The investigators' hypotheses is that there is no difference in the cosmetic outcome of surgical incision during thyroidectomy by either a scalpel or electrocautery.
Justification:
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over 18 years old who have consented to conventional thyroid surgery with Dr. Sam Wiseman at St Paul's Hospital (Vancouver, BC) will be asked to participate.
排除标准
- •Patients will be excluded if they have had prior surgical incisions at the site of expected surgical incision, connective tissue disorders (e.g. Ehrlos Danlos syndrome), known keloid predilection, and lack of informed consent.
结局指标
主要结局
Appearance of surgical scar
时间窗: 12 months post operative
次要结局
- Rate of wound infection(12 months post operative)
研究者
Dr. Sam M. Wiseman
Principal Investigator
St. Paul's Hospital, Canada
