UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052571 |
|---|---|
| Receipt number | R000059983 |
| Scientific Title | Prospective Study on the Efficacy of Bowel Preparation using Sulprep for Total Colonoscopy |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2024/02/03 11:46:16 |
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Basic information
Public title
Prospective Study on the Efficacy of Bowel Preparation using Sulprep for Total Colonoscopy
Acronym
Prospective Study on the Efficacy of Bowel Preparation using Sulprep for Total Colonoscopy
Scientific Title
Prospective Study on the Efficacy of Bowel Preparation using Sulprep for Total Colonoscopy
Scientific Title:Acronym
Prospective Study on the Efficacy of Bowel Preparation using 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 using 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
Tolerability of bowel preparation using sulprep
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who underwent total colonoscopy at our center within the last 2 years with bowel preparation using Movirpep
Key exclusion criteria
Patient with taste disorders
Patient who have difficulty responding to the questionnaire
Patient with allergies to the ingredients of MoviPrep, Niflec, or sodium picosulfate
End-stage renal failure or on dialysis
Patient who could not reach the cecum or anastomosis during the previous total colonoscopy
Patient with severe constipation who are planning to use alternative methods other than the standard bowel preparation
Patient deemed unsuitable by the attending physician
Target sample size
500
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
9830824
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
other
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
| 2023 | Year | 10 | Month | 23 | 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 | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Total colonoscopy with bowel preparation using MoviPrep on individuals who had within approximately 1 to 1.5 years (excluding those beyond 2 years) with the goal of assessing the burden and other aspects of bowel preparation using Salprep and conducting a questionnaire.
Management information
Registered date
| 2023 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059983
