N/A
Completed N=301
Dose the Saline Reduce the Mucus Production When Water Exchange Colonoscopy is Used?
Colon Mucous · Colonoscopy
Source: ClinicalTrials.gov NCT04769739 ↗
Enrolled (actual)
301
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Left Colon Mucus Score — 0.2; 1.4; 0.5; 0.7 score on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Colon Mucus Score |
0.2; 1.4; 0.5; 0.7 | — |
| SECONDARY Adenoma Detection Rate |
35; 31; 41; 35 | — |
| SECONDARY Number of Participants With Cecal Intubation |
70; 75; 76; 75 | — |
| SECONDARY Boston Bowel Preparation Scale Score |
7.0; 7.1; 7.8; 7.6 | — |
| SECONDARY Cecal Intubation Time |
10.0; 18.0; 18.4; 18.6 | — |
| SECONDARY Withdrawal Inspection Time |
20.2; 17.1; 17.2; 16.6 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female 20-75 years of age
- Positive screening for Fecal Immunochemical Test (FIT)
- Subjects willing to undergo routine screening and surveillance colonoscopy
Exclusion Criteria
- Patients who decline to provide informed consent
- Patients known to have colonic obstruction, active inflammatory bowel disease, or active GI bleeding requiring interventions
- Patients known to have prior history of colonic resection
- Patients with genetic colorectal syndromes
- Patients who are scheduled for therapeutic colonoscopy (e.g., hemostasis, removal of large polyp)
- Patients with American Society of Anesthesiology classification of physical status grade 3 or higher
Data sourced from ClinicalTrials.gov (NCT04769739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.