NCT03231917

Water Immersion and Polyp Detection: A Randomized Controlled Trial

Completed NA Results posted Last updated 12 July 2019

What this trial tests

NA trial testing Water Infusion first in Adenoma in 121 participants. Completed in 31 August 2018.

Timeline

1 March 2017

Primary endpoint
31 August 2018

31 August 2018

Quick facts

Lead sponsor	White River Junction Veterans Affairs Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	screening
Enrollment	121
Start date	1 March 2017
Primary completion	31 August 2018
Estimated completion	31 August 2018
Sites	2 locations across United States

Drugs / interventions tested

• Water Infusion first
• CO2 Insufflation First

Conditions studied

• Adenoma — all drugs for Adenoma →
• Colonic Neoplasms — all drugs for Colonic Neoplasms →

Sponsor

White River Junction Veterans Affairs Medical Center

Who can join

50 and older, any sex, with Adenoma or Colonic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adenoma Miss Rate Primary · 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

Group	Value	95% CI
Water Infusion First	52
CO2 Insufflation First	37

Patient-level Miss Rate Secondary · 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

Group	Value	95% CI
Water Infusion First	27
CO2 Insufflation First	23

Adenoma < 6mm Detection Rate Secondary · 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.

Group	Value	95% CI
Water Infusion First	45
CO2 Insufflation First	36

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparing adenoma and polyp miss rates for total underwater colonoscopy versus standard CO₂: a randomized controlled trial using a tandem colonoscopy approach.
   Anderson JC, Kahi CJ, Sullivan A, MacPhail M, et al · · 2019 · cited 19× · PMID 30367879 · DOI 10.1016/j.gie.2018.09.046