UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053562 |
|---|---|
| Receipt number | R000060939 |
| Scientific Title | Prospective study on the efficacy of bowel preparation with the two cup one cup method of Sulprep for total colonoscopy. |
| Date of disclosure of the study information | 2024/02/07 |
| Last modified on | 2024/02/07 07:33:20 |
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Basic information
Public title
Prospective study on the efficacy of bowel preparation with the two cup one cup method of Sulprep for total colonoscopy.
Acronym
Prospective study on the efficacy of bowel preparation with the two cup one cup method of Sulprep for total colonoscopy.
Scientific Title
Prospective study on the efficacy of bowel preparation with the two cup one cup method of Sulprep for total colonoscopy.
Scientific Title:Acronym
Prospective study on the efficacy of bowel preparation with the two cup one cup method of Sulprep for total colonoscopy.
Region
| Japan |
Condition
Condition
Colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of bowel preparation with the two cup one cup method of Sulprep for total colonoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical utility (colon cleansing)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Gastroenterological patients undergoing colonoscopy and patients with consent
Key exclusion criteria
1. Gastrointestinal obstruction or suspected gastrointestinal obstruction
2. Patients with or suspected of having intestinal perforation
3. Toxic megacolonosis or suspected toxic megacolonosis
4. Patients with or suspected of having gastric evacuation disorder (gastric insufficiency paralysis)
5. Patients with intestinal stenosis or severe constipation
6. Patients with vomiting reflex disorder or those at risk of aspiration
7. Patients with a history of gastrointestinal tract surgery
8. Patients with known glucose-6-phosphate dehydrogenase deficiency
9. Patients with renal dysfunction (creatinine clearance less than 30 mL/min)
10. Persons undergoing or requiring treatment for severe cardiac disease
11. Persons at high risk of arrhythmia
12. Patients who are dehydrated
13. Persons who have been determined to have active inflammatory bowel disease during the screening phase
14. Persons under 18 years of age or over 80 years of age
15. Patients who have had hypersensitivity to any of the ingredients in Sulprep Oral Solution in the past.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | KEN |
| Middle name | |
| Last name | OHATA |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8625, Japan
TEL
03-6721-6239
nttihc-ml@east.ntt.co.jp
Public contact
Name of contact person
| 1st name | KOICHI |
| Middle name | |
| Last name | FURUTA |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8625, Japan
TEL
03-6721-6239
Homepage URL
optimum.keyword.0l@icloud.com
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NTT Medical Center Tokyo IRB
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8625, Japan
Tel
03-6721-6239
nttihc-ml@east.ntt.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060939
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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