Skip to main content
OpenTrials
Completed

NCT Number: NCT03231917

Water Immersion and Polyp Detection: A Randomized Controlled Trial

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adenoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut Health Center, Farmington, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Water Infusion first

Procedure

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

Procedure

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

Primary outcomes

  1. Adenoma Miss Rate

    Time frame: 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 outcomes

  1. Patient-level Miss Rate

    Time frame: 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

  2. Adenoma < 6mm Detection Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

White River Junction Veterans Affairs Medical Center

Fed

Collaborators

  • Indiana University

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 27, 2017
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.