UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of peritoneal injury (morphological and adhesionalchanges)using laparoscopy for peritoneal dialisis patients-multicenter study-
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-multicenter study-
Scientific Title:Acronym	Evaluation of peritoneal injury using laparoscopy for peritoneal dialisis patients
Region	Japan

Condition
Condition	peritoneal dialysis patients
Classification by specialty	Nephrology Surgery in general
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Initiation of peritoneal dialysis and withdraw of catheter in Juntendo University nerima hospital or 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 University Nerima Hospital
Division name	Division of Nephrology
Zip code	177-8521
Address	3-1-10 Takanodai Nerima-ku Tokyo, Japan
TEL	03-5923-3111
Email	hiroaki@juntendo.ac.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Io
Organization	Juntendo University Nerima Hospital
Division name	Division of Nephrology
Zip code	177-8521
Address	3-1-10 Takanodai Nerima-ku Tokyo, Japan
TEL	0359233111
Homepage URL
Email	hiroaki@juntendo.ac.jp

Sponsor
Institute	Juntendo Uiversity Nerima Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Juntendo Uiversity Hospital
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
Email	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練馬病院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 10 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	2016 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date	2016 Year 08 Month 09 Day
Last follow-up date
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 Herima Hospital or 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 08 Month 09 Day
Last modified on	2022 Year 04 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027135