UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019203 |
|---|---|
| Receipt number | R000022201 |
| Scientific Title | Comparison between modified simple peritoneal wall anchor technique and traditional catheter insertion method |
| Date of disclosure of the study information | 2015/10/02 |
| Last modified on | 2019/10/05 11:41:23 |
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Basic information
Public title
Comparison between modified simple peritoneal wall anchor technique and traditional catheter insertion method
Acronym
Modified simple peritoneal wall anchor technique
Scientific Title
Comparison between modified simple peritoneal wall anchor technique and traditional catheter insertion method
Scientific Title:Acronym
Modified simple peritoneal wall anchor technique
Region
| Japan |
Condition
Condition
Peritoneal dialysis
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between modified simple peritoneal wall anchor technique and traditional catheter insertion method in peritoneal dialysis catheter survival
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of surgical catheter repair due to outflow obstruction by Day 365
Key secondary outcomes
Occurrence of catheter migration with obstruction requiring any interventions by Day 365
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Modified simple peritoneal wall anchor technique
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who received PD catheter insertion without using laparoscopy
Key exclusion criteria
Nothing
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Oka |
Organization
Matsuyama Red Cross Hospital
Division name
Division of Kidney Center
Zip code
790-8524
Address
1 Bunkyocho, Matsuyama
TEL
089-924-1111
okanokao@matsuyama.jrc.or.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Oka |
Organization
Matsuyama Red Cross Hospital
Division name
Division of Kidney Center
Zip code
790-8524
Address
1 Bunkyocho, Matsuyama
TEL
089-924-1111
Homepage URL
okanokao@matsuyama.jrc.or.jp
Sponsor or person
Institute
Matsuyama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsuyama Red Cross Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsuyama Red Cross Hospital
Address
1 Bunkyocho, Matsuyama
Tel
089-924-1111
soumu@matsuyama.jrc.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
| 2015 | Year | 10 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 02 | Day |
Last modified on
| 2019 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022201
