Tokyo, Nov. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059917) titled 'A Randomized Controlled Trial on the Safety and Efficacy of Jelly Drink Administration Before Upper Gastrointestinal Endoscopy' on Nov. 28.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Suita Municipal Hospital
Condition:
Condition - Individuals scheduled to undergo an upper gastrointestinal endoscopy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - When an upper gastrointestinal endoscopy is scheduled, dietary restrictions apply from the evening before the procedure until the morning of the examination. A randomized trial will verify that consuming oral rehydration jelly allows the procedure to be performed safely, similar to conventional restrictions.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Oral Rehydration Jelly Intake
Interventions/Control_2 - None
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Individuals aged 18 years or older who consent to participate in this study
2. Capable of oral intake
3. Individuals who, after receiving adequate explanation regarding participation in this trial, provided written consent based on full understanding and of their own free will
Key exclusion criteria - 1. Individuals with sodium or potassium intake restrictions
2. Individuals with severe liver disease, kidney disease, heart disease, or other conditions that make participation in this study difficult
3. Individuals with severe pharyngeal or nasal cavity conditions preventing endoscope insertion
4. Individuals in poor general health
5. Individuals requiring emergency endoscopy
6. Individuals undergoing endoscopy for hemostasis purposes
7. Individuals unable to independently decide on trial participation
8. Individuals who understand the trial but do not consent to participate
9. Other individuals deemed unsuitable for this study by the attending physician
Target Size - 120
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 06 Month 12 Day
Date of IRB - 2025 Year 08 Month 05 Day
Anticipated trial start date - 2025 Year 11 Month 07 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068531
Disclaimer: Curated by HT Syndication.
