Water Immersion and Polyp Detection: A Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Adenoma; Colonic Neoplasms
• Interventions: Procedure: CO2 Insufflation First; Procedure: Water Infusion first

• Registration Number: NCT03231917
• Lead Sponsor: White River Junction Veterans Affairs Medical Center

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-27
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Results First Submitted: 2018-10-01
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-23
• Last Update Submitted: 2019-04-23
• Results First Posted: 2019-07-12
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CO2 Insufflation First	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.
Water Infusion first	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.

Primary Outcome Measures

Name	Time	Method
Adenoma Miss Rate	Through procedure, an average of 1 hr	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

Secondary Outcome Measures

Name	Time	Method
Patient-level Miss Rate	1 hour or the duration of the procedure	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
Adenoma < 6mm Detection Rate	1 hour or the duration of the procedure	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.

Trial Locations

Locations (2)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States