Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

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ClinicalTrials.gov Identifier: NCT01535326

Recruitment Status : Completed

First Posted : February 17, 2012

Results First Posted : August 15, 2014

Last Update Posted : August 15, 2014

Sponsor:

Information provided by (Responsible Party):

Yu-Hsi hsieh, Dalin Tzu Chi General Hospital

Study Description

Brief Summary:

In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange).

This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.

Condition or disease	Intervention/treatment	Phase
Colon Neoplasm Pain	Procedure: air insufflation Procedure: water immersion Procedure: water exchange	Not Applicable

Detailed Description:

All procedures will be recorded and stored as digital files.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	270 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Diagnostic
Official Title:	Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial
Study Start Date :	February 2012
Actual Primary Completion Date :	March 2013
Actual Study Completion Date :	March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy Drinking Water

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: air insufflation Use air insufflation during colonoscopy	Procedure: air insufflation insufflate air during the insertion of colonoscopy
Active Comparator: water immersion infuse water during insertion, remove water during withdrawal of colonoscopy	Procedure: water immersion infuse water during insertion, aspirate water during withdrawal
Active Comparator: water exchange infuse and remove water during insertion phase of colonoscopy	Procedure: water exchange infuse and remove water during insertion phase of colonoscopy

Outcome Measures

Primary Outcome Measures :

Proportion of Patients Without Pain [ Time Frame: up to 12 months ]
proportion of patients without insertion pain during colonoscopy

Secondary Outcome Measures :

Patient Pain Score [ Time Frame: 9 to 12 months ]
The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)
Patient Satisfaction Score [ Time Frame: 9 to 12 months ]
satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied
Number of Participants With at Least One Adenoma [ Time Frame: 9 to 12 months ]
the number of participants with at least one adenoma in each of the study groups.

Other Outcome Measures:

Post-procedure Discomforts and 30 Day Complication Rate [ Time Frame: one month ]
telephone follow up for post-procedure discomforts and 30 day complication rate

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients undergoing minimally sedated colonoscopy

Exclusion Criteria:

Obstructive lesions of the colon, inadequate bowel preparation, allergy to meperidine, massive ascites, past history of partial colectomy, or refusal to provide written informed consent.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535326

Locations

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Taiwan
Dalin Tzu Chi General Hospital
Chia-Yi, Taiwan, 622
Dalin Tzu Chi General Hospital
Chiayi, Taiwan, 622

Sponsors and Collaborators

Dalin Tzu Chi General Hospital

Investigators

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Principal Investigator:	Yu-Hsi Hsieh, Dr.	Dalin Tzu Chi General Hospital

More Information

Publications:

Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.

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. Epub 2011 Jul 1.

Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.

Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.

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Responsible Party:	Yu-Hsi hsieh, Chief of department of gastroenterology and hepatology, Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier:	NCT01535326
Other Study ID Numbers:	DalinTCGH-hsieh-01
First Posted:	February 17, 2012 Key Record Dates
Results First Posted:	August 15, 2014
Last Update Posted:	August 15, 2014
Last Verified:	July 2014

Keywords provided by Yu-Hsi hsieh, Dalin Tzu Chi General Hospital:


colonoscopy

Additional relevant MeSH terms:

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Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site	Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases

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