Prospective Randomized Study Comparing the Results of Digital Rectal Examination in the Supine and Lateral Decubitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- realization of a full digital rectal examination
研究概览
简要总结
Digital rectal examination is an act clinically performed daily by physicians and surgeons. It remains the key diagnostic test and directs the therapeutic management of cancer of the lower and middle rectum. It can be done in two main positions: lateral decubitus, and supine.
However, no randomized study in colorectal surgery is not interested in evaluating the best position to perform a full rectal exam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •colon or upper rectum cancer operated or not
- •recurrent of colon or upper rectum cancer
- •rectal bleeding
排除标准
- •paraplegic man
- •bedridden patient
- •current or previous pelvic radiotherapy
- •History of prostatectomy
- •emergency
研究组 & 干预措施
lateral decubitus
The digital rectal examination is performed in lateral decubitus i.e. curled up position . The patient in left lateral decubitus if the examiner is right handed and right lateral decubitus if the examiner is left handed.
干预措施: lateral decubitus (Procedure)
supine decubitus
The digital rectal examination is performed supine, spread legs, feet on the examination table. The examiner is in the patient's right side if he is right handed and in the patient's left side if he is left-handed.
干预措施: supine decubitus (Procedure)
结局指标
主要结局
realization of a full digital rectal examination
时间窗: The consult could be done prior to the surgery or one month after the surgery
Full digital rectal examination is defined by a rectal examination for investigating the superior pole of the prostate, to examine the entire circumference and the rectal sphincter.
次要结局
- Conversion rate decided by the examiner(The consult can be performed prior to the surgery or one month after the surgery)
- Evaluation of the position by the patient(The consult can be performed prior to the surgery or one month after the surgery)
- assessment of sphincter according to the DRESS score(The consult can be performed prior to the surgery or one month after the surgery)
- missing information during the rectal examination(The consult can be performed prior to the surgery or one month after the surgery)