Tokyo, May 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061375) titled 'A study comparing total underwater colonoscopy and CO2 insufflation colonoscopy' on May 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Yamaguchi University

Condition: Condition - Colorectal tumor Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Total underwater colonoscopy (TUC) is a technique in which insertion is performed using water-assisted colonoscopy (WAC), and during withdrawal, the lumen is filled with water without gas insufflation for observation. By achieving moderate luminal distension and improving visibility through the optical properties of water, TUC is theoretically expected to reduce the polyp miss rate. In this study, we compare TUC with CO2 insufflation during colonoscope withdrawal to evaluate withdrawal time, polyp miss rate, and the characteristics of polyps missed by each method. In addition, patient pain scores are assessed to comprehensively examine the usefulness and safety of TUC. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - First perform withdrawal under water immersion, then perform withdrawal using CO2 insufflation. The intervention period is defined as the time from obtaining informed consent to two weeks after the examination and treatment. Interventions/Control_2 - First perform withdrawal using CO2 insufflation, followed by withdrawal under water immersion. The intervention period is defined as the time from obtaining informed consent to two weeks after the examination and treatment.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients undergoing inpatient treatment for colorectal tumors 2. Patients aged 18 years or older at the time of obtaining informed consent 3. No restriction on sex 4. Patients who have received sufficient explanation regarding participation in this study and have provided written informed consent of their own free will with adequate understanding Key exclusion criteria - 1. Patients with a history of colorectal surgery(excluding appendectomy) 2. Patients with inflammatory bowel disease 3. Patients with polyposis 4. Patients with heart failure(NYHA class III or IV) 5. Patients with severe hepatic dysfunction (Child Pugh class B or C) 6. Patients with chronic renal failure undergoing hemodialysis or peritoneal dialysis 7. Pregnant patients 8. Patients deemed ineligible for this study by the investigator Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 10 Day Anticipated trial start date - 2026 Year 05 Month 10 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069941

Disclaimer: Curated by HT Syndication.