Evaluation of the Post-surgical Discomfort in Patients Undergoing Diagnostic Oral Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Correlation between the clinical healing and patient perception
研究概览
简要总结
Aim of this study is to evaluate the post-operative course in patients undergoing diagnostic or therapeutic oral mucosal biopsies.
To evaluate the wound healing, all variables connected with the surgery (including post-operative complications) were recorded. To evaluate the psychological and behavioral impact of the post-operative discomfort, two survey tools were administered: OHIP-14 and visual number scale of pain (VNS) were administered at 6h, 7 days and 21 days after biopsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •no systemic or local contraindications for surgical treatment
- •need for an oral biopsy (both excisional and incisional).
排除标准
- •Since no absolute contraindications to oral biopsies are reported, no exclusion criteria were selected for this study, but if any relative contraindication was present (i.e. bleeding disorders) biopsy was performed after the resolution of the problem
结局指标
主要结局
Correlation between the clinical healing and patient perception
时间窗: Three weeks after an oral biopsy
To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process.
次要结局
- Correlation between OHIP-14 and VNS scale(Three weeks after an oral biopsy)
- Clinical variables which influence the healing and patient perception(Three weeks after an oral biopsy)
研究者
Carlo Lajolo
Associate Professor
Catholic University of the Sacred Heart