UMIN-CTR Clinical Trial

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	irboffice@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	Terminated
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	2022 Year 04 Month 05 Day
Date of closure to data entry	2022 Year 04 Month 05 Day
Date trial data considered complete	2022 Year 04 Month 05 Day
Date analysis concluded	2022 Year 04 Month 05 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 21 Day
Last modified on	2022 Year 11 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033368