Clinical Trial: Evaluation of colonoscopy insertion technique improvement in trainees from various countries using Mikoto colonoscopy model (International Mikoto Study) (Japan)

Tokyo, Dec. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060082) titled 'Evaluation of colonoscopy insertion technique improvement in trainees from various countries using Mikoto colonoscopy model (International Mikoto Study)' on Dec. 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - No treatment

Primary Sponsor: Institute - Saga University

Condition: Condition - Colonoscopy recipients Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify whether training using the Mikoto colonoscopy model in a multicenter international setting improves colonoscopy insertion techniques among trainees. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - mikoto training group Interventions/Control_2 - mikoto non-training group

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1) Patients between 18 and 90 who undergo colonoscopy 2) Patients who need colonoscopy (patients who meet one of the following conditions) Patients with positive fecal immunochemical test Patients who have been diagnosed or treated for colorectal adenoma or colorectal cancer (patients who have undergone colorectal resection are not eligible) Patients with gastrointestinal symptoms such as abdominal pain, diarrhea, constipation, etc Patients who need to be screened for gastrointestinal cancer Patients with a family history of colorectal cancer or colorectal adenoma Key exclusion criteria - 1) Patients who have undergone bowel resection 2) Patients with a history of inflammatory bowel disease 3) Patients with a history of familial adenomatous polyposis 4) Patients with a history of hereditary non-polyposis colorectal cancer 5) Patients with previously known severe intestinal adhesions 6) Patients with severe obesity (BMI > 35 kg/m2) 7) Patients who are pregnant 8) Patients whose previous colonoscopy was judged by the investigator to have been difficult to insert (insertion time > 15 minutes) or who had poor colonoscopy preparation (Modified Aronchick Scale: Poor/Inadequate) 9) Patients who are judged by the investigator to be unable to participate in the study. 10) Patients who declared non-participation in the study Target Size - 420

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2024 Year 05 Month 03 Day Date of IRB - 2024 Year 05 Month 02 Day Anticipated trial start date - 2024 Year 06 Month 14 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=R000068717

Disclaimer: Curated by HT Syndication.