Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

• Sponsor: Dalin Tzu Chi General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01535326
• Collaborator: (none)
• Enrollment: 270
• Locations: 2
• Arms: 3
• Duration (Months): 12.9
• Patients Per Site: 135
• Patients Per Site Per Month: 10.4

Study Details

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	N/A

Detailed Description

All procedures will be recorded and stored as digital files.

Study Design

• Study Type: Interventional
• 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: Feb 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

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

1. Proportion of Patients Without Pain [up to 12 months]

   proportion of patients without insertion pain during colonoscopy

Secondary Outcome Measures

1. Patient Pain Score [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)

2. Patient Satisfaction Score [9 to 12 months]

   satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied

3. Number of Participants With at Least One Adenoma [9 to 12 months]

   the number of participants with at least one adenoma in each of the study groups.

Other Outcome Measures

1. Post-procedure Discomforts and 30 Day Complication Rate [one month]

   telephone follow up for post-procedure discomforts and 30 day complication rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Dalin Tzu Chi General Hospital	Chia-Yi		Taiwan	622
2	Dalin Tzu Chi General Hospital	Chiayi		Taiwan	622

Sponsors and Collaborators

• Dalin Tzu Chi General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

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.

• 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: Feb 17, 2012
• Last Update Posted: Aug 15, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Yu-Hsi hsieh, Chief of department of gastroenterology and hepatology, Dalin Tzu Chi General Hospital: colonoscopy
• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Air Insufflation	Water Immersion	Water Exchange
Arm/Group Description	Use air insufflation during colonoscopy air insufflation: insufflate air during the insertion of colonoscopy	infuse water during insertion, remove water during withdrawal of colonoscopy water immersion: infuse water during insertion, aspirate water during withdrawal	infuse and remove water during insertion phase of colonoscopy water exchange: infuse and remove water during insertion phase of colonoscopy
Period Title: Overall Study
STARTED	90	90	90
COMPLETED	90	90	90
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Air Insufflation	Water Immersion	Water Exchange	Total
Arm/Group Description	Use air insufflation during colonoscopy air insufflation: insufflate air during the insertion of colonoscopy	infuse water during insertion, remove water during withdrawal of colonoscopy water immersion: infuse water during insertion, aspirate water during withdrawal	infuse and remove water during insertion phase of colonoscopy water exchange: infuse and remove water during insertion phase of colonoscopy	Total of all reporting groups
Overall Participants	90	90	90	270
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	59	53	58	55
Sex: Female, Male (Count of Participants)
Female	30 33.3%	37 41.1%	35 38.9%	102 37.8%
Male	60 66.7%	53 58.9%	55 61.1%	168 62.2%

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients Without Pain
Description	proportion of patients without insertion pain during colonoscopy
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Air Insufflation	Water Immersion	Water Exchange
Arm/Group Description	Use air insufflation during colonoscopy air insufflation: insufflate air during the insertion of colonoscopy Proportion of no pain: 30%	infuse water during insertion, remove water during withdrawal of colonoscopy water immersion: infuse water during insertion, aspirate water during withdrawal Proportion of no pain: 43.3%	infuse and remove water during insertion phase of colonoscopy water exchange: infuse and remove water during insertion phase of colonoscopy Proportion of no pain: 61.1%
Measure Participants	90	90	90
Number [participants]	27 30%	39 43.3%	55 61.1%

2. Secondary Outcome

Title	Patient Pain Score
Description	The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)
Time Frame	9 to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Air Insufflation	Water Immersion	Water Exchange
Arm/Group Description	Use air insufflation during colonoscopy air insufflation: insufflate air during the insertion of colonoscopy	infuse water during insertion, remove water during withdrawal of colonoscopy water immersion: infuse water during insertion, aspirate water during withdrawal	infuse and remove water during insertion phase of colonoscopy water exchange: infuse and remove water during insertion phase of colonoscopy
Measure Participants	90	90	90
Median (Full Range) [units on a scale]	3.5	1.8	0

3. Secondary Outcome

Title	Patient Satisfaction Score
Description	satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied
Time Frame	9 to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Air Insufflation	Water Immersion	Water Exchange
Arm/Group Description	Use air insufflation during colonoscopy air insufflation: insufflate air during the insertion of colonoscopy	infuse water during insertion, remove water during withdrawal of colonoscopy water immersion: infuse water during insertion, aspirate water during withdrawal	infuse and remove water during insertion phase of colonoscopy water exchange: infuse and remove water during insertion phase of colonoscopy
Measure Participants	90	90	90
Median (Full Range) [units on a scale]	10	10	10

4. Secondary Outcome

Title	Number of Participants With at Least One Adenoma
Description	the number of participants with at least one adenoma in each of the study groups.
Time Frame	9 to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Air Insufflation	Water Immersion	Water Exchange
Arm/Group Description	Use air insufflation during colonoscopy air insufflation: insufflate air during the insertion of colonoscopy	infuse water during insertion, remove water during withdrawal of colonoscopy water immersion: infuse water during insertion, aspirate water during withdrawal	infuse and remove water during insertion phase of colonoscopy water exchange: infuse and remove water during insertion phase of colonoscopy
Measure Participants	90	90	90
Number [participants]	39 43.3%	41 45.6%	51 56.7%

5. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Air Insufflation		Water Immersion		Water Exchange
Arm/Group Description	Use air insufflation during colonoscopy air insufflation: insufflate air during the insertion of colonoscopy		infuse water during insertion, remove water during withdrawal of colonoscopy water immersion: infuse water during insertion, aspirate water during withdrawal		infuse and remove water during insertion phase of colonoscopy water exchange: infuse and remove water during insertion phase of colonoscopy
All Cause Mortality
	Air Insufflation		Water Immersion		Water Exchange
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Air Insufflation		Water Immersion		Water Exchange
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/90 (0%)		1/90 (1.1%)
Gastrointestinal disorders
perforation	0/90 (0%)	0	0/90 (0%)	0	1/90 (1.1%)	1
Other (Not Including Serious) Adverse Events
	Air Insufflation		Water Immersion		Water Exchange
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/90 (0%)		0/90 (0%)

Limitations/Caveats

Single center; single endoscopist

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.