Water Immersion and Polyp Detection: A Randomized Controlled Trial

N/ACompletedNCT03231917

White River Junction Veterans Affairs Medical Center121 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

121

Conditions

Adenoma Colonic Neoplasms

Interventions

Water Infusion firstPROCEDURE

In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.

CO2 Insufflation FirstPROCEDURE

In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion .

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

University of Connecticut Health Center

Farmington, Connecticut, United States

Indiana University Hospital

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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

Time frame: Through procedure, an average of 1 hr

Secondary Outcomes

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

Time frame: 1 hour or the duration of the procedure

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.

Time frame: 1 hour or the duration of the procedure

Data from ClinicalTrials.gov

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