Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

NCT01535326 | Completed Results

• 1 other identifier: DalinTCGH-hsieh-01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Neoplasm; Pain

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Without Pain

  proportion of patients without insertion pain during colonoscopy

  up to 12 months

Secondary Outcomes (3)

• Patient Pain Score

  9 to 12 months

• Patient Satisfaction Score

  9 to 12 months

• Number of Participants With at Least One Adenoma

  9 to 12 months

Other Outcomes (1)

• Post-procedure Discomforts and 30 Day Complication Rate

  one month

Study Arms (3)

air insufflation

PLACEBO COMPARATOR

Use air insufflation during colonoscopy

Procedure: air insufflation

water immersion

ACTIVE COMPARATOR

infuse water during insertion, remove water during withdrawal of colonoscopy

Procedure: water immersion

water exchange

ACTIVE COMPARATOR

infuse and remove water during insertion phase of colonoscopy

Procedure: water exchange

Interventions

air insufflation PROCEDURE

insufflate air during the insertion of colonoscopy

air insufflation

water immersion PROCEDURE

infuse water during insertion, aspirate water during withdrawal

water immersion

water exchange PROCEDURE

infuse and remove water during insertion phase of colonoscopy

water exchange

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing minimally sedated colonoscopy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead

Study Sites (1)

Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, 622, Taiwan

Location

Related 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.

  PMID: 21633535 BACKGROUND

• 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.

  PMID: 22163081 BACKGROUND

• 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.

  PMID: 21184876 BACKGROUND

• 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.

  PMID: 19555938 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Pain

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Single center; single endoscopist

Results Point of Contact

• Title: Dr. Yu-Hsi Hsieh
• Organization: Dalin Tzu Chi Hospital

hsieh.yuhsi@msa.hinet.net

88652648000

Study Officials

• Yu-Hsi Hsieh, Dr.

  Dalin Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of department of gastroenterology and hepatology

Study Record Dates

• First Submitted: February 11, 2012
• First Posted: February 17, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 15, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-07

Locations

TW (1)