UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033859
Receipt number 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 2019/08/26 09:53:47

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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 Tsutomu
Middle name
Last name Sakurada

Organization

St. Marianna University School of Medicine

Division name

Division of Nephrology and Hypertension

Zip code

216-8511

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 Tsutomu
Middle name
Last name Sakurada

Organization

St. Marianna University School of Medicine

Division name

Division of Nephrology and Hypertension

Zip code

216-8511

Address

2-16-1 Sugao, MIyamae-ku, Kawasaki, Kanagawa, Japan

TEL

+81-44-977-8111

Homepage URL


Email

sakurada@marianna-u.ac.jp


Sponsor or person

Institute

The Japanese Society for Dialysis Therapy

Institute

Department

Personal name



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

Medical ethics committee of St. Marianna University School of Medicine

Address

2-16-1 Sugao, MIyamae-ku, Kawasaki, Kanagawa, Japan

Tel

+81-44-977-8111

Email

daigakuin@marianna-u.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



Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

288

Results

Laparoscopic surgery was found to have no favorable effect on catheter survival.
The incidence of catheter migration was significantly lower with laparoscopic surgery.
However, the significance decreased on limiting the analysis to RCTs involving laparoscopic surgery without secured suture of the PD catheter.
Other outcomes were similar between open surgery and laparoscopic surgery.

Results date posted

2019 Year 08 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures

Primary outcome
Catheter survival

Secondary outcomes
leakage
hernia
PD catheter-related infection
Requirement for reoperation
Postoperative pain
Hospitalization period associated with catheter placement
Catheter migration

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 09 Month 01 Day

Date of IRB

2018 Year 09 Month 01 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 08 Month 22 Day


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

2019 Year 08 Month 26 Day



Link to view the page

Value
https://center6.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