Water Exchange Versus Carbon Dioxide for Colonoscopy
2014年2月11日 更新者：Sorlandet Hospital HF
Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial
Colonoscopy is commonly used in screening for colorectal cancer.
A refined technique of colonoscopy involving the use of water as the sole modality to aid colonoscope insertion, water exchange, has been described in recent research papers to decrease patient discomfort and pain, and to reduce the need for sedation during colonoscopy when compared with standard air insufflation.
Carbon dioxide insufflation has been described to decrease patient discomfort after colonoscopy.
No randomized trial has so far compared the use of water exchange to carbon dioxide insufflation.
Our hypothesis is that water exchange inflicts less discomfort to patients undergoing colonoscopy than carbon dioxide insufflation.
Patients undergoing screening colonoscopy in two centers in Norway, one center in Poland and one center in The Netherlands will be enrolled and randomized to examination of either of the two methods.
研究概览
详细说明
Single blinded randomized controlled trial.
研究类型
介入性
注册 (实际的)
473
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
50年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients scheduled for screening or polyp surveillance colonoscopy
- Patients accepting sedation on demand
Exclusion Criteria:
- Demand for sedation/analgesia before the start of the procedure
- Previous partial or total colonic resection
- Pregnancy
- Unwilling/unable to provide informed consent
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
- 主要用途：放映
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Water exchange
Colonoscopy with water exchange as the sole modality to reach the cecum.
Carbon dioxide can be used in case of intubation failure with the test method.
|
Water is infused and suctioned in a systematic fashion to obtain luminal view and for cleansing of the colon to facilitate colonoscope insertion.
The carbon dioxide pump is turned off, only to be turned on during withdrawal from the cecum.
其他名称：
|
|
有源比较器：Carbon dioxide insufflation
Carbon dioxide insufflation will be used in standard fashion to reach the cecum.
|
Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure.
其他名称：
|
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 |
|---|---|---|
|
Pain during colonoscopy
大体时间：1 hour
|
Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.
|
1 hour
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain during colonoscopy
大体时间：30 minutes
|
Patients will be asked to report pain during colonoscopy to an unblinded study assistant.
|
30 minutes
|
|
Cecal intubation rate
大体时间：1 hour
|
Cecal intubation rate is defined as successful completion of colonoscopy insertion.
This will be analyzed on an intention-to-treat basis according to group allocation.
|
1 hour
|
|
Cecal intubation time
大体时间：1 hour
|
The time taken to complete insertion of the colonoscope.
|
1 hour
|
|
Adenoma detection rate
大体时间：1 hour
|
Detection of adenomas during each colonoscopy procedure
|
1 hour
|
|
Polyp detection rate
大体时间：1 hour
|
Detection of any colonic polyp, irrespective of histologic type, during each procedure.
|
1 hour
|
|
Dose of medication
大体时间：1 hour
|
Dose of sedative and analgesic medication needed to complete the colonoscopy.
|
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。
合作者
调查人员
- 首席研究员：Kjetil K Garborg, MD、Sorlandet Hospital HF Kristiansand, Norway
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
- Leung F, Harker J, Leung J, Siao-Salera R, Mann S, Ramirez F, Friedland S, Amato A, Radaelli F, Paggi S, Terruzzi V, Hsieh Y. Removal of infused water predominantly during insertion (water exchange) is consistently associated with a greater reduction of pain score - review of randomized controlled trials (RCTs) of water method colonoscopy. J Interv Gastroenterol. 2011 Jul;1(3):114-120. doi: 10.4161/jig.1.3.18510. Epub 2011 Jul 1.
- Riss S, Akan B, Mikola B, Rieder E, Karner-Hanusch J, Dirlea D, Mittlbock M, Weiser FA. CO2 insufflation during colonoscopy decreases post-interventional pain in deeply sedated patients: a randomized controlled trial. Wien Klin Wochenschr. 2009;121(13-14):464-8. doi: 10.1007/s00508-009-1202-y.
- Ramirez FC, Leung FW. A head-to-head comparison of the water vs. air method in patients undergoing screening colonoscopy. J Interv Gastroenterol. 2011 Jul;1(3):130-135. doi: 10.4161/jig.1.3.18512. Epub 2011 Jul 1.
- Leung FW, Leung JW, Siao-Salera RM, Mann SK, Jackson G. The water method significantly enhances detection of diminutive lesions (adenoma and hyperplastic polyp combined) in the proximal colon in screening colonoscopy - data derived from two RCT in US veterans. J Interv Gastroenterol. 2011 Apr;1(2):48-52. doi: 10.4161/jig.1.2.16826.
- Denberg TD, Melhado TV, Coombes JM, Beaty BL, Berman K, Byers TE, Marcus AC, Steiner JF, Ahnen DJ. Predictors of nonadherence to screening colonoscopy. J Gen Intern Med. 2005 Nov;20(11):989-95. doi: 10.1111/j.1525-1497.2005.00164.x.
- Khalid-de Bakker CA, Jonkers DM, Hameeteman W, de Ridder RJ, Masclee AA, Stockbrugger RW. Cardiopulmonary events during primary colonoscopy screening in an average risk population. Neth J Med. 2011 Apr;69(4):186-91.
- Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Patient time requirements for screening colonoscopy. Am J Gastroenterol. 2007 Nov;102(11):2401-10. doi: 10.1111/j.1572-0241.2007.01387.x. Epub 2007 Jun 29.
- Leung FW, Leung JW, Mann SK, Friedland S, Ramirez FC. The water method significantly enhances patient-centered outcomes in sedated and unsedated colonoscopy. Endoscopy. 2011 Sep;43(9):816-21. doi: 10.1055/s-0030-1256407. Epub 2011 May 24.
- Leung F, Harker J, Leung J, Siao-Salera R, Mann S, Ramirez F, Friedland S, Amato A, Radaelli F, Paggi S, Terruzzi V, Hsieh Y. Removal of infused water predominantly during insertion (water exchange) is consistently associated with an increase in adenoma detection rate - review of data in randomized controlled trials (RCTs) of water-related methods. J Interv Gastroenterol. 2011 Jul;1(3):121-126. doi: 10.4161/jig.1.3.18517. Epub 2011 Jul 1.
- Stevenson GW, Wilson JA, Wilkinson J, Norman G, Goodacre RL. Pain following colonoscopy: elimination with carbon dioxide. Gastrointest Endosc. 1992 Sep-Oct;38(5):564-7. doi: 10.1016/s0016-5107(92)70517-3.
- Bretthauer M, Thiis-Evensen E, Huppertz-Hauss G, Gisselsson L, Grotmol T, Skovlund E, Hoff G. NORCCAP (Norwegian colorectal cancer prevention): a randomised trial to assess the safety and efficacy of carbon dioxide versus air insufflation in colonoscopy. Gut. 2002 May;50(5):604-7. doi: 10.1136/gut.50.5.604.
- 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.
- Church J, Delaney C. Randomized, controlled trial of carbon dioxide insufflation during colonoscopy. Dis Colon Rectum. 2003 Mar;46(3):322-6. doi: 10.1007/s10350-004-6549-6.
- Wong JC, Yau KK, Cheung HY, Wong DC, Chung CC, Li MK. Towards painless colonoscopy: a randomized controlled trial on carbon dioxide-insufflating colonoscopy. ANZ J Surg. 2008 Oct;78(10):871-4. doi: 10.1111/j.1445-2197.2008.04683.x.
- Uraoka T, Kato J, Kuriyama M, Hori K, Ishikawa S, Harada K, Takemoto K, Hiraoka S, Fujita H, Horii J, Saito Y, Yamamoto K. CO(2) insufflation for potentially difficult colonoscopies: efficacy when used by less experienced colonoscopists. World J Gastroenterol. 2009 Nov 7;15(41):5186-92. doi: 10.3748/wjg.15.5186.
- Geyer M, Guller U, Beglinger C. Carbon dioxide insufflation in routine colonoscopy is safe and more comfortable: results of a randomized controlled double-blinded trial. Diagn Ther Endosc. 2011;2011:378906. doi: 10.1155/2011/378906. Epub 2011 Jun 15.
- Leung FW, Leung JW, Mann SK, Friedland S, Ramirez FC, Olafsson S. DDW 2011 cutting edge colonoscopy techniques - state of the art lecture master class - warm water infusion/CO(2) insufflation for colonoscopy. J Interv Gastroenterol. 2011 Apr;1(2):78-82. doi: 10.4161/jig.1.2.16830. Erratum In: J Interv Gastroenterol. 2011 Jul;1(3):141.
- Hoff G, Bretthauer M, Huppertz-Hauss G, Kittang E, Stallemo A, Hoie O, Dahler S, Nyhus S, Halvorsen FA, Pallenschat J, Vetvik K, Kristian Sandvei P, Friestad J, Pytte R, Coll P. The Norwegian Gastronet project: Continuous quality improvement of colonoscopy in 14 Norwegian centres. Scand J Gastroenterol. 2006 Apr;41(4):481-7. doi: 10.1080/00365520500265208.
- Garborg K, Kaminski MF, Lindenburger W, Wiig H, Hasund A, Wronska E, Bie RB, Kleist B, Lovdal L, Holme O, Kalager M, Hoff G, Bretthauer M. Water exchange versus carbon dioxide insufflation in unsedated colonoscopy: a multicenter randomized controlled trial. Endoscopy. 2015 Mar;47(3):192-9. doi: 10.1055/s-0034-1390795. Epub 2014 Nov 20.
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
2012年6月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2012年6月29日
首先提交符合 QC 标准的
2012年7月3日
首次发布 (估计)
2012年7月4日
研究记录更新
最后更新发布 (估计)
2014年2月12日
上次提交的符合 QC 标准的更新
2014年2月11日
最后验证
2014年2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.