UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057779 |
|---|---|
| Receipt number | R000066036 |
| Scientific Title | Oral and intravenous antibiotic prophylaxis for colonoscopy in peritoneal dialysis patients in Japan |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/05/05 19:00:48 |
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Basic information
Public title
Oral and intravenous antibiotic prophylaxis for colonoscopy in peritoneal dialysis patients in Japan
Acronym
Oral and intravenous antibiotic prophylaxis for colonoscopy in peritoneal dialysis patients in Japan
Scientific Title
Oral and intravenous antibiotic prophylaxis for colonoscopy in peritoneal dialysis patients in Japan
Scientific Title:Acronym
Antibiotic prophylaxis for colonoscopy in peritoneal dialysis patients
Region
| Japan |
Condition
Condition
Peritoneal dialysis patients undergoing colonoscopy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of oral and intravenous antibiotic prophylaxis in preventing colonoscopy-related peritonitis in peritoneal dialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of colonoscopy-associated peritonitis
Key secondary outcomes
Incidence of peritonitis associated with colonoscopy, with and without invasive colonoscopic procedures. Outcome of colonoscopy-associated peritonitis, the causative organisms in colonoscopy-associated peritonitis.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Peritoneal dialysis patients undergoing colonoscopy.
Key exclusion criteria
1 Patients with diverticulitis or other peritonitis at the time of lower gastrointestinal endoscopy.
2 Patients who used antimicrobials during lower gastrointestinal endoscopy for reasons other than prophylactic medication.
3 Patients whose consent could not be obtained.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Naohiro |
| Middle name | |
| Last name | Toda |
Organization
Kansai Electric Power Hospital
Division name
Department of Nephrology
Zip code
553-0003
Address
2-1-7, Fukushima. Fukushima-ku. Osaka.
TEL
+81-6-6458-5821
natoda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Naohiro |
| Middle name | |
| Last name | Toda |
Organization
Kansai Electric Power Hospital
Division name
Department of Nephrology
Zip code
553-0003
Address
2-1-7, Fukushima. Fukushima-ku. Osaka.
TEL
+81-6-6458-5821
Homepage URL
natoda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Nephrology, Kansai Electric Power Hospital
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
Kansai Electric Power Hospital, ethics committee
Address
2-1-7, Fukushima. Fukushima-ku. Osaka.Kansai Electric Power Hospital
Tel
0664585821
natoda@kuhp.kyoto-u.ac.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
| 2025 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multicentre observational study
Management information
Registered date
| 2025 | Year | 05 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066036
