Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 6
- 主要终点
- Change in abdominal bloating sensation after colonoscopy.
研究概览
简要总结
Room air insufflated during colonoscopy cannot be completely suctioned, is not easily absorbed and remains in the bowel for quite some time, resulting in prolonged bowel distension with the discomfort of bloating. Sufferers often experience a sensation of fullness and abdominal pressure, relieved only after expulsion of the residual gas, often accompanied by colic pain. This can be a lengthy process, and some patients continue to report pain as long as 24 hours after the procedure. Abdominal discomfort after colonoscopy is an adverse event commonly reported by patients, and definitely associated with the procedure. Published reports show that the use of carbon dioxide (CO2) insufflation significantly decreases bloating and pain up to 24 hours post-procedure. Preliminary results of the investigators' previous study about on-demand sedation colonoscopy in diagnostic patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion of water to distend the lumen during insertion; suction of infused water, residual air pockets an feces predominantly during insertion) achieved significantly lower real-time insertion pain scores. Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2. Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences were significant only at discharge. The investigators decided to conduct a prospective randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2. The investigators will test the hypothesis that patients examined by the combination of WE-CO2 will have significantly lower bloating scores at specific time points after colonoscopy than those examined using WE-AI or CO2-CO2. The investigators will also assess the impact of these three methods on patients comfort and activities in the post-procedure period.
详细描述
Design: Prospective double blinded two-center randomized controlled trial. Methods: Colonoscopy with CO2 insufflation and water exchange-CO2, water exchange-AI; split-dose bowel preparation; on demand-sedation.
Control method: CO2 insufflation colonoscopy. Study methods: water exchange-CO2 colonoscopy, water exchange-AI colonoscopy.
Population: Consecutive 18 to 80 year-old first-time diagnostic outpatients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consecutive 18 to 80 year-old first-time diagnostic outpatients agreeing to start procedure without premedication
排除标准
- •patient unwillingness to start the procedure without sedation/analgesia
- •previous colorectal surgery
- •proctosigmoidoscopy or bidirectional endoscopy
- •patient refusal or inability to provide informed consent
- •inadequate consumption of bowel preparation
- •moderate or severe chronic obstructive pulmonary disease requiring oxygen
- •medical history of CO2 retention
- •history of inflammatory bowel disease
结局指标
主要结局
Change in abdominal bloating sensation after colonoscopy.
时间窗: Within the first 24 hours after the procedure.
Change of patients' sensation of abdominal bloating. Assessed by blinded observer just after examination, at discharge; and at 1, 3, 6, 12 and 24 hours after the procedure using a questionnaire given to patients. Measured on an eleven-point Numeric Rating Scale (NRS): 0=none, 10=full bloating. Results will be recorded by telephone recall.
次要结局
- Toilet use for bowel movement post-procedure.(6 hours.)
- Real-time insertion pain.(1 hour.)
- Number of episodes of incontinence or of soiled underwear experienced in the 6 hours after colonoscopy.(6 hours.)
- Number of flatus episodes post-procedure.(24 hours.)
- Number of incontinence episodes post-procedure.(6 hours.)
- Interference of colonoscopy on work/normal activities the same day of the procedure.(Up to 12 hours.)
- Day of work missed the day after the procedure.(24 hours.)
- Change in pain score after colonoscopy.(Within the first 24 hours after the procedure.)
- Willingness to repeat colonoscopy.(24 hours.)
- Patients' satisfaction with the procedure.(24 hours.)
研究者
Sergio Cadoni, M.D.
Responsabile Servizio Endoscopia Digestiva
Presidio Ospedaliero Santa Barbara