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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033859
Receipt No. R000038607
Scientific Title Outcomes after Peritoneal Dialysis Catheter Placement by Laparoscopic Surgery versus Open Surgery: Systematic Review and Meta-Analysis
Date of disclosure of the study information 2018/09/01
Last modified on 2018/09/05

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Basic information
Public title Outcomes after Peritoneal Dialysis Catheter Placement by Laparoscopic Surgery versus Open Surgery: Systematic Review and Meta-Analysis
Acronym Outcomes after Peritoneal Dialysis Catheter Placement by Laparoscopic Surgery versus Open Surgery: Systematic Review and Meta-Analysis
Scientific Title Outcomes after Peritoneal Dialysis Catheter Placement by Laparoscopic Surgery versus Open Surgery: Systematic Review and Meta-Analysis
Scientific Title:Acronym Outcomes after Peritoneal Dialysis Catheter Placement by Laparoscopic Surgery versus Open Surgery: Systematic Review and Meta-Analysis
Region
Japan

Condition
Condition Adult end-stage renal disease patients initiating peritoneal dialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether catheter insertion by laparoscopic surgery is useful compared to catheter insertion by open surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Catheter survival
Key secondary outcomes Complications (early complications: leakage, late complications: hernia)
PD catheter related infection (exit site infection and tunnel infection)
Requiring reoperation
Postoperative pain
Hospitalization
Migration

Base
Study type Others,meta-analysis etc

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

Not applicable
Gender Male and Female
Key inclusion criteria Laparoscopic surgery versus open surgery on peritoneal dialysis catheter placement: Randomized controlled trial
Key exclusion criteria Observational study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Sakurada
Organization St. Marianna University School of Medicine
Division name Division of Nephrology and Hypertension
Zip code
Address 2-16-1 Sugao, MIyamae-ku, Kawasaki, Kanagawa, Japan
TEL +81-44-977-8111
Email sakurada@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Sakurada
Organization St. Marianna University School of Medicine
Division name Division of Nephrology and Hypertension
Zip code
Address 2-16-1 Sugao, MIyamae-ku, Kawasaki, Kanagawa, Japan
TEL +81-44-977-8111
Homepage URL
Email sakurada@marianna-u.ac.jp

Sponsor
Institute The Japanese Society for Dialysis Therapy
Institute
Department

Funding Source
Organization The Japanese Society for Dialysis Therapy
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
Address
Tel
Email

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
2018 Year 09 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
2018 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Literature Search Strategy
Literature search will carry out in MEDLINE and CENTRAL. The search will be performed for articles published up to April 2017.
Literature Screening
Studies will be evaluated for inclusion by two independent authors. Differences regarding eligibility will be resolved by consensus and with the help of the senior author. The following type of studies will be excluded such as reviews, case reports, letters, editorials, case series, observational study and papers studying animal or infants.
Data Extraction
The level of evidence will be established by using GRADE tool. The quality and potential of bias of the randomized controlled trials will be assessed according to the Cochrane Collaborations tool for assessing risk of bias by Higgins.
Statistical Analysis
A metaanalysis will be performed with the catheter survival and complications as outcome measures using Review Manager Software.

Management information
Registered date
2018 Year 08 Month 22 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038607

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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