UMIN-CTR Clinical Trial

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 Ryuta Middle name Last name Tanimoto
Organization	Kagawa Prefectural Central Hospital
Division name	Urology
Zip code	7608557
Address	1-2-1 Asahimachi, Takamatsu, Kagawa
TEL	087-811-3333
Email	tanimo10@gmail.com

Public contact
Name of contact person	1st name Ryuta Middle name Last name Tanimoto
Organization	Kagawa Prefectural Central Hospital
Division name	Urology
Zip code	7608557
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	Kagawa Prefectural Central Hospital
Address	Asahimachi 1-2-1, Takamatsu, Kagawa
Tel	0878113333
Email	tanimo10@gmail.com

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	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 01 Day
Date of IRB	2018 Year 12 Month 10 Day
Anticipated trial start date	2019 Year 01 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 12 Month 31 Day
Date trial data considered complete	2022 Year 12 Month 31 Day
Date analysis concluded	2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 12 Month 14 Day
Last modified on	2021 Year 12 Month 16 Day

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