The Effect of Body Positioning for Colonoscopy in Women: Randomized, Study of Left Lateral Tilt Down Versus Left Lateral Horizontal Positioning
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure
研究概览
简要总结
A tortuous sigmoid colon makes colonoscopy difficult. The purpose of this study was to systematically evaluate the diagnostic utility and incidence of adverse events in women using standard horizontal compared to lateral tilt down positioning for colonoscopy.
详细描述
This was a prospective, randomized study. Subjects who provide informed consent and present to the offices of Specialists in Gastroenterology for colonoscopy will be randomized in a 1:1 distribution to either left lateral tilt down versus left lateral horizontal positioning to initiate colonoscopy.
Demographic data as well as routine information regarding the colonoscopy was filled out during or at the end of each procedure. In addition, the following parameters were assessed, and compared between groups:
- Occurrence of complications related or possibly related to the colonoscopy procedure
- Scope insertion time
- Pain during and after the procedure
The subjects' participation was limited to the duration of the colonoscopy, which is typically less than 60 min and a follow up by telephone 24 hours later to assess the occurrence of complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ability to understand and sign consent
- •women and men with a BMI (body mass index) <35 kg/m2
- •age 18 - 90 years
- •no liquids by mouth for ≥2 hours
- •no solid food for ≥8 hours
排除标准
- •inability to provide informed consent
- •morbid obesity (BMI ≥35)
- •pregnancy
- •uncontrolled gastroesophageal reflux disease
- •gastroparesis
- •scleroderma
- •achalasia
- •Crohn's disease
- •ulcerative colitis
- •history of a colon resection
- •Parkinson's disease
- •brain tumor
- •multiple sclerosis
- •ischemic optic neuropathy
- •active pulmonary infection
- •liquid intake <2 hours
- •solid food intake <8 hours prior to the procedure
- •intra-procedure findings of a stricture resulting in an incomplete colonoscopy or Boston bowel preparation scores of <6
结局指标
主要结局
Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure
时间窗: 24 hours
The number of participants who experience adverse events which are related or possibly related to the colonoscopy procedure will be tallied in each treatment arm.
次要结局
- Time to Full Colonoscope Insertion(30 minutes)
- Pain Related or Possibly Related to Colonoscopy Procedure(24 hours)