UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053527 |
|---|---|
| Receipt number | R000061063 |
| Scientific Title | Questionnaire Survey on the User Experience of Sulprep and Niflec for Colonoscopy Preparation |
| Date of disclosure of the study information | 2024/02/05 |
| Last modified on | 2024/02/03 11:44:31 |
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Basic information
Public title
Questionnaire Survey on the User Experience of Sulprep and Niflec for Colonoscopy Preparation
Acronym
Questionnaire Survey on the User Experience of Sulprep and Niflec for Colonoscopy Preparation
Scientific Title
Questionnaire Survey on the User Experience of Sulprep and Niflec for Colonoscopy Preparation
Scientific Title:Acronym
Questionnaire Survey on the User Experience of Sulprep and Niflec for Colonoscopy Preparation
Region
| Japan |
Condition
Condition
Colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness of Suprep as a pre-procedural medication for colonoscopy with the existing pre-procedural medication, Niflec.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The burden of pre-procedural preparation with Suprep compared to Niflec in surveys.
Key secondary outcomes
Ease of ingestion of the laxative, efficacy in bowel cleansing, volume of laxative and water intake, adverse events, etc., comparing Suprep and Niflec in surveys.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who are considered to require colon polyp removal surgery following Total Colonoscopy with pre-procedural preparation using Sulprep at our outpatient center, followed by a subsequent two-night hospital stay.
Participants who have provided consent for participation in the study via paper documentation.
Individuals aged 18 years and older.
Key exclusion criteria
Exclude individuals who meet any of the following criteria
Individuals with evident taste disorders.
Individuals who have difficulty responding to questionnaires.
Individuals with uncertain or unknown intake of laxatives or fluids, or those where uncertainty is anticipated.
Individuals with allergies to the ingredients of Sulprep, Nifrec, or sodium picosulfate.
Individuals unable to take the recommended dose of Sulprep.
Individuals with lesions requiring procedures such as endoscopic submucosal dissection rather than typical polypectomy or mucosal resection.
Patients with end-stage renal failure or undergoing dialysis.
Patients in whom the cecum or anastomosis could not be reached during TCS.
Patients in whom serious conditions such as advanced cancer were identified during TCS, aside from polyps suitable for removal.
Patients who experienced serious adverse events during TCS.
Patients with severe constipation planning to use methods other than the standard pre-procedural measures.
Individuals deemed inappropriate by the attending physician.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Shibuya |
Organization
Sendai city medical center Sendai open hospital
Division name
department of Gastroenteology
Zip code
983-0824
Address
5-22-1 Tsurugaya, Miyagino Ward, Sendai City, Miyagi Prefecture, Japan
TEL
0222521111
you.s.together@openhp.or.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Shibuya |
Organization
Sendai city medical center Sendai open hospital
Division name
department of Gastroenteology
Zip code
9830824
Address
5-22-1 Tsurugaya, Miyagino Ward, Sendai City, Miyagi Prefecture, Japan
TEL
0222521111
Homepage URL
you.s.together@openhp.or.jp
Sponsor or person
Institute
Sendai city medical center Sendai open hospital, department of Gastroenteology, Yuta Shibuya.
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sendai city medical center Sendai open hospital
Address
5-22-1 Tsurugaya, Miyagino Ward, Sendai City, Miyagi Prefecture, Japan
Tel
0222521111
k.tochikubo@openhp.or.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 | 05 | 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
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registration of cases will conclude either upon reaching the target number of cases or upon the completion of the study period.
Management information
Registered date
| 2024 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061063
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
