The Impact of Distraction on Adenoma Detection Rate

Adenoma Clinical Trial

Official title:

The Impact of Distraction on Adenoma Detection Rate in Patients Undergoing Colonoscopy With Air Insufflation, Water Immersion and Water Exchange

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978664
• Other study ID #: DalinHsieh201401
• Status: Completed
• Phase: N/A
• First received: April 8, 2016
• Last updated: November 28, 2016
• Start date: October 2014
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Dalin Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The investigators will review video-recordings of three randomized, controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi Hospital.

Description:

The investigators will review video-recordings of three randomized controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange. These studies were conducted at Buddhist Dalin Tzu Chi Hospital. Permission will be obtained from the local Institutional Review Board (IRB) to review, analyze and report de-identified findings.

Two experienced endoscopists (YHH and CWT) performed all the recorded colonoscopies. Recordings will be selected for review if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers. Patients with incomplete recordings and a history of bowel resection will be excluded from analysis. The included video recordings will be edited to remove the insertion phase to blind the study reviewer to the insertion techniques. One blinded reviewer uninvolved in the performance of the colonoscopies will be in charge of evaluating the selected videos, using the criteria described by Yung et al

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers.

Exclusion Criteria:

• Patients with incomplete recordings and a history of bowel resection will be excluded from analysis.

Study Design

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

Related Conditions & MeSH terms

• Adenoma

Intervention

Procedure:
• Air insufflation
Air insufflation during colonoscopy including insertion phase
• water immersion
Water will infused during insertion phase and removed during withdrawal phase of colonoscopy.
• Water exchange
Water will infused and removed during insertion phase of colonoscopy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Lee RH, Tang RS, Muthusamy VR, Ho SB, Shah NK, Wetzel L, Bain AS, Mackintosh EE, Paek AM, Crissien AM, Saraf LJ, Kalmaz DM, Savides TJ. Quality of colonoscopy withdrawal technique and variability in adenoma detection rates (with videos). Gastrointest Endosc. 2011 Jul;74(1):128-34. doi: 10.1016/j.gie.2011.03.003. — View Citation

Leung FW. Water exchange may be superior to water immersion for colonoscopy. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1012-4. doi: 10.1016/j.cgh.2011.09.007. — View Citation

Yung VY, Yen AW, Leung JW, Mann SK, Wilson MD, Leung FW. Validation of a novel method for analyzing video recordings of the withdrawal phase of air insufflation and water exchange colonoscopy - documentation of distractions from focused mucosal inspection. J Interv Gastroenterol. 2014 Jan;4(1):8-12.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adenoma detection rate		one week after colonoscopy	No
Secondary	Distraction score		Immediate after video reviewing	No
Secondary	Withdrawal technique as specified by Lee RH (citation 1)	adequacy of distention (0-5), fold examination (0-5) and cleaning (0-5) for each colonic segment	immediate after video reviewing	No
Secondary	Bowel preparation score	Boston bowel preparation score	immediate after video reviewing	No