Water Immersion and Polyp Detection: A Randomized Controlled Trial

Colonic Neoplasms Clinical Trial

Official title:

Water Immersion and Polyp Detection: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231917
• Other study ID #: 1000344-1
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: April 2019
• Source: White River Junction Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We plan to conduct a randomized trial of tandem colonoscopies comparing water infusion and air insufflation for inspection of mucosa on withdrawal. In one randomized group, water infusion will be employed as the first method for mucosal inspection while in a second group, CO2 insufflation will be used first. This study will be different than usual care since the participants will receive two successive or tandem colonoscopies versus one

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• all adults 50 years or older who present for colonoscopy at White River Junction VAMC and Indiana University

Exclusion Criteria:

• includes co-morbid status of ASA III or higher, Inflammatory Bowel Disease (IBD), surgical resection of the large bowel, as well as the use of anticoagulants. Finally, potential subjects who do not report a clear effluent in the most recent bowel movement will be excluded from the study.

Related Conditions & MeSH terms

• Adenoma
• Colonic Neoplasms

Intervention

Procedure:
• Water Infusion first
In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
• CO2 Insufflation First
In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion .

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
White River Junction Veterans Affairs Medical Center	Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma Miss Rate	Adenoma-level miss rates will be calculated as the number of additional adenomas detected during the second examination divided by the total number of adenomas detected during both examinations	Through procedure, an average of 1 hr
Secondary	Patient-level Miss Rate	Patient-level miss rates will be calculated as the number of patients with one or more adenomas detected during the second examination, divided by the total number of patients with at least one adenoma in either examination	1 hour or the duration of the procedure
Secondary	Adenoma < 6mm Detection Rate	Adenoma-level miss rates will be calculated as the number of additional adenomas < 6 mm detected during the second examination divided by the total number of adenomas< 6 mm detected during both examinations.	1 hour or the duration of the procedure