Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes
2015年11月4日 更新者：Sergio Cadoni, M.D.、Presidio Ospedaliero Santa Barbara
Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
246
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- consecutive 18 to 80 year-old first-time diagnostic outpatients agreeing to start procedure without premedication
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Carbon dioxide method
Colonoscopy performed as usual, with the minimal CO2 insufflation required to aid insertion and adequate distension during withdrawal for exploration.
Washing allowed as needed.
Considered to be standard procedure.
|
Insufflation with CO2 during insertion and withdrawal phases of colonoscopy.
|
|
实验性的：Water Exchange-CO2
Insufflation not used until the cecum is reached.
Infusion of a sufficient amount of water to render the lumen a slit to progress with the colonoscope.
Part of the infused water will be constantly suctioned back exchanging clean for opaque water.
Air pockets and residual feces will be always aspirated.
Withdrawal phase done using carbon dioxide insufflation.
|
Insertion using water exchange, withdrawal using CO2 insufflation.
|
|
实验性的：Water Exchange-AI
Insufflation not used until the cecum is reached.
Infusion of a sufficient amount of water to render the lumen a slit to progress with the colonoscope.
Part of the infused water will be constantly suctioned back exchanging clean for opaque water.
Air pockets and residual feces will be always aspirated.
Withdrawal phase done using air insufflation.
|
Insertion using water exchange, withdrawal using air insufflation.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in abdominal bloating sensation after colonoscopy.
大体时间：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.
|
Within the first 24 hours after the procedure.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in pain score after colonoscopy.
大体时间：Within the first 24 hours after the procedure.
|
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 using an eleven-point NRS (0=none, 10=maximum pain).
Results will be recorded by telephone recall.
|
Within the first 24 hours after the procedure.
|
|
Real-time insertion pain.
大体时间：1 hour.
|
Pain assessed using a NRS (0=absence of pain, 2=simply "discomfort", 10=worst pain).
Before the procedure, an endoscopic nurse will explain the NRS scoring system to the patients.
At irregular intervals during colonoscopy (around 60 seconds) assisting nurse will ask patients about discomfort or pain.
The responses will be recorded, and the maximum pain score noted.
Colonoscopists not participating in gathering the informations.
|
1 hour.
|
|
Number of episodes of incontinence or of soiled underwear experienced in the 6 hours after colonoscopy.
大体时间：6 hours.
|
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
6 hours.
|
|
Number of flatus episodes post-procedure.
大体时间：24 hours.
|
Recorded at discharge and assessed post-procedure up to 24 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
24 hours.
|
|
Number of incontinence episodes post-procedure.
大体时间：6 hours.
|
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
6 hours.
|
|
Toilet use for bowel movement post-procedure.
大体时间：6 hours.
|
Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
6 hours.
|
|
Patients' satisfaction with the procedure.
大体时间：24 hours.
|
Assessed post-procedure after 24 hours using a questionnaire given to patients (0=not satisfied, 10=very satisfied).
Results will be recorded by telephone recall.
|
24 hours.
|
|
Willingness to repeat colonoscopy.
大体时间：24 hours.
|
Assessed post-procedure after 24 hours using a questionnaire given to patients (0=not willing to repeat, 10=very likely to repeat).
Results will be recorded by telephone recall.
|
24 hours.
|
|
Interference of colonoscopy on work/normal activities the same day of the procedure.
大体时间：Up to 12 hours.
|
Assessed post-procedure after 12 hours using a questionnaire given to patients (0=nothing at all, 10=a lot).
Results will be recorded by telephone recall.
|
Up to 12 hours.
|
|
Day of work missed the day after the procedure.
大体时间：24 hours.
|
Work activities missed the day after colonoscopy due to some effect of the procedure (yes, no).
Assessed post-procedure after 24 hours using a questionnaire given to patients.
Results will be recorded by telephone recall.
|
24 hours.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cecal intubation rate.
大体时间：1 hour.
|
Cecal intubation will be defined as reaching beyond the ileocecal valve with adequate visualization of the appendix orifice.
|
1 hour.
|
|
Cecal intubation time.
大体时间：1 hour.
|
Defined as the time for passage of the colonoscope from the rectum to the cecum.
|
1 hour.
|
|
Total procedure time.
大体时间：1 hour.
|
Total procedure time (including time required for water infusion, polyp resection or biopsy).
|
1 hour.
|
|
Adenoma detection rate.
大体时间：9 months.
|
Proportion of subjects with at least one adenoma of any size.
|
9 months.
|
|
On-demand sedation.
大体时间：1 hour.
|
Offered at patient request for a NRS score ≥2.
Medications given as per institutional regulation.
Dose titrated based on patients' reported real-time pain score, age, weight and comorbidity.
|
1 hour.
|
|
Oxygen desaturation.
大体时间：1 hour.
|
Significant oxygen desaturation (<85% for >15 seconds) will be recorded.
|
1 hour.
|
|
Vagal reaction.
大体时间：1 hour.
|
Vagal reaction (heart rate <60 beats per minute accompanied by excessive sweating, nausea and/or vomiting) will be recorded.
|
1 hour.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Sergio Cadoni, MD、S. Barbara Hospital, Iglesias (CI) Italy
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Sumanac K, Zealley I, Fox BM, Rawlinson J, Salena B, Marshall JK, Stevenson GW, Hunt RH. Minimizing postcolonoscopy abdominal pain by using CO(2) insufflation: a prospective, randomized, double blind, controlled trial evaluating a new commercially available CO(2) delivery system. Gastrointest Endosc. 2002 Aug;56(2):190-4. doi: 10.1016/s0016-5107(02)70176-4.
- Zubarik R, Fleischer DE, Mastropietro C, Lopez J, Carroll J, Benjamin S, Eisen G. Prospective analysis of complications 30 days after outpatient colonoscopy. Gastrointest Endosc. 1999 Sep;50(3):322-8. doi: 10.1053/ge.1999.v50.97111.
- de Jonge V, Sint Nicolaas J, van Baalen O, Brouwer JT, Stolk MF, Tang TJ, van Tilburg AJ, van Leerdam ME, Kuipers EJ; SCoPE consortium. The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. Am J Gastroenterol. 2012 Jun;107(6):878-84. doi: 10.1038/ajg.2012.40. Epub 2012 Mar 6.
- Lee YC, Wang HP, Chiu HM, Lin CP, Huang SP, Lai YP, Wu MS, Chen MF, Lin JT. Factors determining post-colonoscopy abdominal pain: prospective study of screening colonoscopy in 1000 subjects. J Gastroenterol Hepatol. 2006 Oct;21(10):1575-80. doi: 10.1111/j.1440-1746.2006.04145.x.
- Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.
- Cadoni S, Falt P, Gallittu P, Liggi M, Smajstrla V, Leung FW. Impact of carbon dioxide insufflation and water exchange on postcolonoscopy outcomes in patients receiving on-demand sedation: a randomized controlled trial. Gastrointest Endosc. 2017 Jan;85(1):210-218.e1. doi: 10.1016/j.gie.2016.05.021. Epub 2016 May 17.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年4月1日
初级完成 (实际的)
2015年11月1日
研究完成 (实际的)
2015年11月1日
研究注册日期
首次提交
2015年3月23日
首先提交符合 QC 标准的
2015年4月1日
首次发布 (估计)
2015年4月7日
研究记录更新
最后更新发布 (估计)
2015年11月5日
上次提交的符合 QC 标准的更新
2015年11月4日
最后验证
2015年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.