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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035259
Receipt No. R000039603
Scientific Title Prospective randomized study of supraumbilical versus transumbilical camera port in robotic assisted laparoscopic prostatectomy
Date of disclosure of the study information 2018/12/14
Last modified on 2018/12/14

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Basic information
Public title Prospective randomized study of supraumbilical versus transumbilical camera port in robotic assisted laparoscopic prostatectomy
Acronym The impact of transumbilical camera port in robotic assisted laparoscopic prostatectomy
Scientific Title Prospective randomized study of supraumbilical versus transumbilical camera port in robotic assisted laparoscopic prostatectomy
Scientific Title:Acronym The impact of transumbilical camera port in robotic assisted laparoscopic prostatectomy
Region
Japan

Condition
Condition patients who will have robotic assisted laparoscopic prostatectomy for localized prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Supra umbilical camera port has generally been used in robotic assisted laparoscopic prostatectomy. Trans umbilical camera port may have cosmetic advantages. In this study, we compare the clinical outcomes including cosmetic advantage and postoperative pain and complications.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes body image scale and cosmetic scale 7 days, 1 month and 3 months after operation
Key secondary outcomes pain score and QoL questions 7 days, 1 month and 3 months after operation, postoperative complications within 3 months

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 transumbilical camera port
Interventions/Control_2 supraumbilical camera port
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
Key inclusion criteria The patients who have robotic assisted laparoscopic prostatectomy for localized prostate cancer
Key exclusion criteria The patients who had histories of abdominal surgery
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuta Tanimoto
Organization Kagawa Prefectural Central Hospital
Division name Urology
Zip code
Address 1-2-1 Asahimachi, Takamatsu, Kagawa
TEL 087-811-3333
Email tanimo10@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Ryuta Tanimoto
Organization Kagawa Prefectural Central Hospital
Division name Urology
Zip code
Address 1-2-1 Asahimachi, Takamatsu, Kagawa
TEL 087-811-3333
Homepage URL
Email tanimo10@gmail.com

Sponsor
Institute Kagawa Prefectural Central Hospital
Institute
Department

Funding Source
Organization None
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 香川県立中央病院

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 14 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 11 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 04 Month 30 Day
Date analysis concluded
2021 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 12 Month 14 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039603

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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