Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

Pain Clinical Trial

Official title:

Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535326
• Other study ID #: DalinTCGH-hsieh-01
• Status: Completed
• Phase: N/A
• First received: February 11, 2012
• Last updated: July 28, 2014
• Start date: February 2012
• Est. completion date: March 2013

Study information

• Verified date: July 2014
• Source: Dalin Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

All procedures will be recorded and stored as digital files.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colon Neoplasm
• Colonic Neoplasms
• Pain

Intervention

Procedure:
• air insufflation
insufflate air during the insertion of colonoscopy
• water immersion
infuse water during insertion, aspirate water during withdrawal
• water exchange
infuse and remove water during insertion phase of colonoscopy

Locations

Country	Name	City	State
Taiwan	Dalin Tzu Chi General Hospital	Chia-Yi
Taiwan	Dalin Tzu Chi General Hospital	Chiayi

Sponsors (1)

Lead Sponsor	Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-procedure Discomforts and 30 Day Complication Rate	telephone follow up for post-procedure discomforts and 30 day complication rate	one month	No
Primary	Proportion of Patients Without Pain	proportion of patients without insertion pain during colonoscopy	up to 12 months	No
Secondary	Patient Pain Score	The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)	9 to 12 months	No
Secondary	Patient Satisfaction Score	satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied	9 to 12 months	No
Secondary	Number of Participants With at Least One Adenoma	the number of participants with at least one adenoma in each of the study groups.	9 to 12 months	No