UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029229 |
|---|---|
| Receipt number | 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 | 2022/11/08 09:12:38 |
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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
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
ctroffice@sakuhp.or.jp
Sponsor or person
Institute
Saku Central Hospital Advanced Care Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033368
