NCT04769739

Dose the Saline Reduce the Mucus Production When Water Exchange Colonoscopy is Used?

Completed NA Results posted Last updated 5 January 2024

What this trial tests

NA trial testing CO2 in Colon Mucous in 301 participants. Completed in 30 April 2022.

Timeline

4 August 2021

Primary endpoint
23 March 2022

30 April 2022

Quick facts

Lead sponsor	Evergreen General Hospital, Taiwan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	screening
Enrollment	301
Start date	4 August 2021
Primary completion	23 March 2022
Estimated completion	30 April 2022
Sites	1 location across Taiwan

Drugs / interventions tested

• CO2 — full drug profile →
• Water (WATER) — full drug profile →
• 50% saline
• 25% saline

Conditions studied

• Colon Mucous — all drugs for Colon Mucous →
• Colonoscopy — all drugs for Colonoscopy →

Sponsor

Evergreen General Hospital, Taiwan

Who can join

Adults 20 to 75, any sex, with Colon Mucous or Colonoscopy. 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.

Left Colon Mucus Score Primary · 2 hours (data collected during colonoscopy procedure)

The amount of residual mucus in the left colon (descending colon, sigmoid colon, rectum) is scaled by a mucus score (5-point scale): score 0: no visible mucus; score 1: minimal amounts of clear mucus in thin streaks or strands; score 2: mild opaque mucus in thin strands; score 3: moderate opaque mucus in thicker clumps covering one side of surface; score 4: more opaque mucus in thicker clumps covering more views of lumen.

Group	Value	95% CI
CO2 Insufflation	0.2	± 0.38
WE With Water	1.4	± 0.84
WE With 50% Saline	0.5	± 0.50
WE With 25% Saline	0.7	± 0.63

Adenoma Detection Rate Secondary · one week (data analyzed after the pathology results were available)

The percentage of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected according to the pathology reports.

Group	Value	95% CI
CO2 Insufflation	35
WE With Water	31
WE With 50% Saline	41
WE With 25% Saline	35

Number of Participants With Cecal Intubation Secondary · 2 hours (data collected during colonoscopy procedure)

Number of participants who had a colonoscopy images confirming visualization of ileocecal valve/appendix orifice and the medial wall of the cecum with colonoscope tip touching floor of cecum

Group	Value	95% CI
CO2 Insufflation	70
WE With Water	75
WE With 50% Saline	76
WE With 25% Saline	75

Boston Bowel Preparation Scale Score Secondary · 2 hours (data collected during colonoscopy procedure)

Three iindividual segments (right colon, transverse colon, left colon), each with score of 0 to 3 (poor to excellent) will be evlauated separately using the Boston Bowel Preparation Scale. A tota Boston Bowel Preparation Scale score, sum of three-segmental score (range 0-9), will be reported.

Group	Value	95% CI
CO2 Insufflation	7.0	± 0.5
WE With Water	7.1	± 0.7
WE With 50% Saline	7.8	± 0.7
WE With 25% Saline	7.6	± 0.7

Cecal Intubation Time Secondary · 2 hours (data collected during colonoscopy procedure)

Total time from insertion into the anus to arrival in the cecum

Group	Value	95% CI
CO2 Insufflation	10.0	± 6.0
WE With Water	18.0	± 6.2
WE With 50% Saline	18.4	± 7.1
WE With 25% Saline	18.6	± 9.1

Withdrawal Inspection Time Secondary · 2 hours (data collected during colonoscopy procedure)

Total inspection time during withdrawal from the cecum to the anus

Group	Value	95% CI
CO2 Insufflation	20.2	± 6.4
WE With Water	17.1	± 5.4
WE With 50% Saline	17.2	± 5.3
WE With 25% Saline	16.6	± 5.4

Sponsor's own description

This is a study to compare the left colon mucus production between carbon dioxide (CO2) insufflation and water exchange (WE) colonoscopy in patients that require a routine or repeat colonoscopy. There will be four arms in this study: CO2 insufflation (control group 1), WE with water infusion (control group 2), WE with 50% saline infusion (study group 1), and WE with 25% saline infusion (study group 2). The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The WE control group will use sterile water filling during colonoscope insertion. The study method will use saline filling during colonoscopy insertion. This study will confirm if using the saline infusion is a better method in reducing mucus production when WE colonoscopy is used.

Publications & conference data

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

1. Randomized Trial Comparing Left Colon Mucus Production Using Water vs Saline During Water Exchange Colonoscopy.
   Cheng CL, Kuo YL, Liu NJ, Lien JM, et al · · 2023 · cited 2× · PMID 37141104 · DOI 10.14309/ctg.0000000000000594