UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057045 |
|---|---|
| Receipt number | R000065198 |
| Scientific Title | Comparison of In-Hospital and At-Home Administration of Bowel Preparation Agents Before Outpatient Colonoscopy in Elderly Patients |
| Date of disclosure of the study information | 2025/02/16 |
| Last modified on | 2025/02/16 15:50:58 |
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Basic information
Public title
Comparison of In-Hospital and At-Home Administration of Bowel Preparation Agents Before Outpatient Colonoscopy in Elderly Patients
Acronym
Bowel preparation methods for the elderly
Scientific Title
Comparison of In-Hospital and At-Home Administration of Bowel Preparation Agents Before Outpatient Colonoscopy in Elderly Patients
Scientific Title:Acronym
Bowel preparation methods for the elderly
Region
| Japan |
Condition
Condition
Elderly people aged 70 and over
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compared the outcomes of in-hospital (Group A) versus at-home (Group B) bowel preparation in elderly patients to clarify the usefulness of in-hospital bowel preparation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bowel preparation time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
in-hospital bowel preparation
Interventions/Control_2
at-home bowel preparation
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study participants were outpatients aged 70 years or older who had consented to participate in the study and were undergoing a colonoscopy.
Key exclusion criteria
Patients aged 69 years or younger, those unable to take the bowel preparation agents themselves, those who did not understand how to take the bowel preparation agents, and those unable to undergo the colonoscopy on the same day as they took the bowel preparation agents were excluded. In addition, patients with serious complications (heart failure, renal failure, hepatic failure, respiratory failure), pregnant women, lactating women, and patients with a history of allergy to the study drug were excluded.
Target sample size
151
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
National Hospital Organization Ureshino Medical Center
Division name
Gastroenterology
Zip code
8430393
Address
4279-3 Shimojyukukou, Ureshino city, Saga
TEL
0954431120
daisukehawks@gmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
National Hospital Organization Ureshino Medical Center
Division name
Gastroenterology
Zip code
8430393
Address
4279-3 Shimojyukukou, Ureshino city, Saga
TEL
0954431120
Homepage URL
daisukehawks@gmail.com
Sponsor or person
Institute
National Hospital Organization Ureshino Medical Center (Clinical Research Department)
Institute
Department
Personal name
Daisuke Yamaguchi
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Review Committee of the National Hospital Organization Ureshino Medical Center
Address
4279-3 Shimojyukukou, Ureshino city, Saga
Tel
0954431120
daisukehawks@gmail.com
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
| 2025 | Year | 02 | Month | 16 | Day |
Related information
URL releasing protocol
https://ureshino.hosp.go.jp/about/ethics.html
Publication of results
Partially published
Result
URL related to results and publications
https://ureshino.hosp.go.jp/about/ethics.html
Number of participants that the trial has enrolled
151
Results
After PSM, 26 matched pairs were analyzed. Group A had a significantly shorter bowel preparation time (192.1 vs. 271.1 minutes, P<0.001), shorter time from preparation to colonoscopy (259.3 vs. 341.4 minutes, P<0.001), and fewer defecations (8.5vs. 11.2, P<0.001) than Group B.
Results date posted
| 2025 | Year | 02 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
151 patients aged 70 years or older undergoing outpatient colonoscopy
Participant flow
151 patients were prospectively enrolled (51 in Group A and 100 in Group B).
Adverse events
There were no significant intergroup differences in adverse events.
Outcome measures
26 matched pairs were analyzed. Group A had a significantly shorter bowel preparation time (192.1 vs. 271.1 minutes, P<0.001), shorter time from preparation to colonoscopy (259.3 vs. 341.4 minutes, P<0.001), and fewer defecations (8.5 vs. 11.2, P<0.001) than Group B.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065198
