UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020431 |
|---|---|
| Receipt number | R000023597 |
| Scientific Title | Evaluation of peritoneal injury (morphological and adhesionalchanges)using laparoscopy for peritoneal dialisis patients |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2022/04/15 18:01:07 |
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Basic information
Public title
Evaluation of peritoneal injury (morphological and adhesionalchanges)using laparoscopy for peritoneal dialisis patients
Acronym
Evaluation of peritoneal injury using laparoscopy for peritoneal dialisis patients
Scientific Title
Evaluation of peritoneal injury (morphological and adhesionalchanges)using laparoscopy for peritoneal dialisis patients
Scientific Title:Acronym
Evaluation of peritoneal injury using laparoscopy for peritoneal dialisis patients
Region
| Japan |
Condition
Condition
peritoneal dialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis between laparoscopic, tissue findings and patients characteristics, factors of peritoneal degradation in peritoneal dialysis patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficasy of using laparoscopy for evaluation of peritoneal findings in peritoneal dialysis patients
Key secondary outcomes
Safty of using laparoscopy for withdrawing of peritoneal catheter in peritoneal dialysis patients
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Initiation of peritoneal dialysis and withdraw of catheter in Juntendo University hospital
Key exclusion criteria
If this is not the case
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Io |
Organization
Juntendo Nerima hospital
Division name
Division of Nephrology
Zip code
177-8521
Address
3-1-10 Takanodai Nerima-ku Tokyo, Japan
TEL
0359233111
hiroaki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Io |
Organization
Juntendo Nerima hospital
Division name
Division of Nephrology
Zip code
177-8521
Address
3-1-10 Takanodai Nerima-ku Tokyo, Japan
TEL
0359233111
Homepage URL
hiroaki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Uiversity Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Juntendo University
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
hongo-rinri@juntendo.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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrolling by invitation
Retrospective cohort study
Initiation of peritoneal dialysis and withdraw of catheter in Juntendo University hospital upward 1996
Efficasy and safety of using laparoscopy for evaluation of peritoneal findings in peritoneal dialysis patients
Analysis between laparoscopic, tissue findings and patients characteristics, factors of peritoneal degradation in peritoneal dialysis patients
Management information
Registered date
| 2016 | Year | 01 | Month | 04 | Day |
Last modified on
| 2022 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023597
