UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056069 |
|---|---|
| Receipt number | R000063840 |
| Scientific Title | Percutaneous versus surgical techniques for peritoneal dialysis catheter insertion: A randomized controlled trial |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/10/18 19:09:32 |
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Basic information
Public title
Percutaneous versus surgical techniques for peritoneal dialysis
catheter insertion: A randomized controlled trial
Acronym
SUPER PD trial
Scientific Title
Percutaneous versus surgical techniques for peritoneal dialysis
catheter insertion: A randomized controlled trial
Scientific Title:Acronym
SUPER PD trial
Region
| Japan |
Condition
Condition
Peritoneal dialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the complication rates between percutaneous and open peritoneal dialysis catheter insertion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse events related to peritoneal dialysis catheters (wound infection, peritonitis, catheter exit site infection, tunnel infection, abdominal organ injury, intraperitoneal bleeding, poor drainage, catheter obstruction, leak, hernia)
Key secondary outcomes
Discontinuation of peritoneal dialysis or catheter removal due to adverse events (excluding transition to hemodialysis at the patient's request and kidney transplantation), postoperative pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Percutaneous peritoneal dialysis catheter insertion
Interventions/Control_2
Open surgical peritoneal dialysis catheter insertion
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
(1) Patients who are 18 years of age or older at the time of obtaining consent
(2) Patients who have fully understood the necessity of participating in this study and have given their own voluntary written consent
Key exclusion criteria
(1) Patients who have had multiple abdominal surgeries and are expected to have difficulty inserting a peritoneal dialysis catheter
(2) Patients taking steroids or immunosuppressants
(3) Patients who are severely obese and cannot undergo ultrasound-guided puncture
(4) Patients who require urgent initiation of peritoneal dialysis
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Shinzato |
Organization
Shizuoka General Hospital
Division name
Department of Nephrology
Zip code
420-8527
Address
4-27-1, Kitaando-Higashi, Aoi ward, Shizuoka city, Shizuoka
TEL
054-247-6111
shinzatotakahiro@hotmail.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Shinzato |
Organization
Shizuoka General Hospital
Division name
Department of Nephrology
Zip code
420-8527
Address
4-27-1, Kitaando-Higashi, Aoi ward, Shizuoka city, Shizuoka
TEL
054-247-6111
Homepage URL
shinzatotakahiro@hotmail.com
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
No organization
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
Shizuoka General Hospital
Address
4-27-1, Kitaando-Higashi, Aoi ward, Shizuoka city, Shizuoka
Tel
054-247-6111
shinzatotakahiro@hotmail.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
| 2024 | Year | 12 | 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
| 2024 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 12 | 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
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063840
