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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029229
Receipt No. R000033368
Scientific Title Transanal and transperineal total prostatectomy with total mesorectal excision for lower rectal cancer and proctal cancer
Date of disclosure of the study information 2017/09/22
Last modified on 2019/03/26

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Basic information
Public title Transanal and transperineal total prostatectomy with total mesorectal excision for lower rectal cancer and proctal cancer
Acronym Transanal and transperineal total prostatectomy with total mesorectal excision
Scientific Title Transanal and transperineal total prostatectomy with total mesorectal excision for lower rectal cancer and proctal cancer
Scientific Title:Acronym Transanal and transperineal total prostatectomy with total mesorectal excision
Region
Japan

Condition
Condition Lower Rectal Cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We are going to perform transanal (TaTMEP) and transperienal (TpTMEP) total prostatectomy with total mesorectal excision for the lower rectal cancer which invades the only middle part of the seminal vesicles or the prostate to achieve the proper surgical field and further improvement in manipulation. We investigate the safety, the oncological usefulness and the urinary function in TaTMEP and TpTMEP.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Surgical bleeding, surgical time, circumferential resected margin of the surgical specimen, leakage at the anastomotic site between the bladder and the urethra, post-surgical urinary function regarding voiding and continence
Key secondary outcomes Post-surgical complications including urinary tract infection, pelvic abscess, paresis of intestine, and leakage at the coloanal anastomotic site post sphincter preserving surgery, closure rate of covering ileostoma, 3-year local recurrence rate, 3-year overall survival rate, and 3-year disease-free survival.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Transanal and transperineal total prostatectomy with total mesorectal excision
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) The patients with the lower rectal cancer which invades the only middle part of the seminal vesicles or the prostate.
2) The patients who agreed the entry of this study of their own free will in writing by a principal or a substitute after they had comprehended it well by enough explanation.
Key exclusion criteria 1) The patients with the lower rectal cancer which had widespread invasion of the seminal vesicles, the prostate, the pelvic nerve, the urinary bladder, and the urethra are excluded.
2) The patients who underwent neoadjuvant CRT in particular more than 45 Gry are e excluded because of much risk of leakage of the anastomotic site between the urinary bladder and the urethra.
3) When the proper surgical field or further improvement in manipulation cannot be obtained during TaTMEP or TpTMEP, the approach method should be changed into other approaches such as laparoscopy or open laparotomy, or other surgical methods such as transanal or transperineal total pelvic exenteration.
4) The patients who are inappropriate as the subjects of this study by the corresponding doctor are excluded.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Dai
Middle name
Last name Uematsu
Organization Saku Central Hospital Advanced Care Center
Division name Digestive Surgery
Zip code 385-0051
Address 3400-28 Nakagomi, Saku, 385-0051 JAPAN
TEL 0267-62-8181
Email gorontadu1110@circus.ocn.ne.jp

Public contact
Name of contact person
1st name Miyuki
Middle name
Last name Niimi
Organization Saku Central Hospital Advanced Care Center
Division name Clinical Research Center
Zip code 385-0051
Address 3400-28 Nakagomi, Saku, 385-0051 JAPAN
TEL 0267-62-8181
Homepage URL
Email ctroffice@sakuhp.or.jp

Sponsor
Institute Saku Central Hospital Advanced Care Center
Institute
Department

Funding Source
Organization Saku Central Hospital Advanced Care Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saku Central Hospital Group Research Ethics Committee
Address 197 Usuda, Saku, 384-0301 JAPAN
Tel 0267-82-3131
Email ctroffice@sakuhp.or.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 佐久総合病院 佐久医療センター

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 22 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
2017 Year 09 Month 13 Day
Date of IRB
2017 Year 09 Month 13 Day
Anticipated trial start date
2017 Year 09 Month 25 Day
Last follow-up date
2023 Year 09 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 21 Day
Last modified on
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033368

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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