Randomized Prospective Study for the Comparison of Sample Biopsy Using Scalpel or Er:YAG Laser
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- histological assessability
研究概览
简要总结
For certain changes in the oral mucosa a histopathological examination of the affected tissue is indicated to confirm the diagnosis. The gold standard is the biopsy by scalpel. The aim of this study is to compare the alternative method of tissue sampling using the erbium doped yttrium aluminium garnet (Er:YAG) laser with the gold Standard.
详细描述
Various parameters are compared, such as the pain intensity during and after the biopsy, the evaluation of the tissue removed by the histopathologist, the occurrence of bleeding during and after the removal and the time required for both therapies.
Patients who agree to participate in the study will be randomized (randomly) to either therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Indication for biopsy of the oral mucosa
- •male and female adult patients
- •Written consent of the participating persons after clarification
排除标准
- •pregnancy
- •Taking blood thinners
- •Known infectious diseases
- •Untreated diabetes mellitus
- •Taking immunosuppressants
研究组 & 干预措施
Biopsy with Er: YAG
Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser under previous local anesthesia
干预措施: Biopsy (Procedure)
Biopsy with Scalpel
Biopsies taken with Er: YAG are compared with biopsies taken with a scalpel in patients with lichenoid or leukoplakic changes of the oral mucosa.
干预措施: Biopsy (Procedure)
结局指标
主要结局
histological assessability
时间窗: 13 month
The primary endpoint is the histological assessability of the samples. This is evaluated by the histologist and divided into degrees 0-3. The Subdivision of the artifacts takes place according to the following degrees: 0: none, 1: slight artifacts, not affecting the evaluation of the sample, 2: moderate artifacts, slight deterioration in the evaluability of the sample, 3: severe artifacts, severely impaired
次要结局
- postoperative pain(13 month)
- postoperative bleeding(13 month)
- time for removal(13 month)