Effects of Visualization of Pre-operative Defects on Patient Satisfaction After Facial Reconstruction for Skin Cancer Resection.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.
研究概览
简要总结
The purpose of this study is to assess the effects of visualization of skin cancer resection defects on the face on the post-operative satisfaction of patients after their reconstruction. To achieve this aim, patients invited to participate in this study will be randomized to either seeing or not seeing their skin cancer excision defect prior to reconstruction. After reconstruction, patient satisfaction will be assessed in both groups to determine if visualization of the defect prior to reconstruction has any effect on patient satisfaction and if any detected effect has durability over time.
详细描述
Purpose:
The purpose of this study is to assess patient satisfaction after reconstruction of Mohs skin cancer resection defects in the face, with the resection defect either seen or unseen by the patient. In this way, the investigators will determine the effects of visualization of the pre-operative defects on patient satisfaction after facial reconstruction. Any effects on patient satisfaction that are identified will then be tracked over time.
Hypothesis:
The null hypothesis for this study is that patient satisfaction after reconstruction of Mohs defects on the face is unaffected by the opportunity to visualize the defect prior to reconstruction, and that this observation persists over time. Furthermore, patients are able to recall the size of their cancer resection defect as accurately from a detailed description as from seeing the defect in a mirror.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients recruited for this study must undergo Mohs resection of skin cancer of the face with negative margins at the completion of their cancer resection.
- •Patients recruited for this study must have a post cancer resection defect on the face at least 1.5 centimeters in size in the greatest dimension.
- •Patients recruited for this study must undergo single stage repair of their post cancer resection defect with primary closure or local flaps.
- •Patients must be from the Greater Vancouver area.
排除标准
- •Patients with insufficient visual acuity to be able to appreciate wound and scarring changes to their face post-operatively will be excluded.
- •Patients lacking the cognitive capacity to complete the data collection forms utilized in this study will be excluded.
- •Patients suffering from significant psychiatric conditions will be excluded.
结局指标
主要结局
Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.
时间窗: The day of reconstruction.
Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction site will be assessed on a ten point scale on the day of surgery.
次要结局
- Ability to recall cancer excision defect size.(3 months after reconstruction)
- Symptomatic scarring(3 months after reconstruction)
- Persistence of patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.(2 weeks, and 3 months after reconstruction.)