UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040305 |
|---|---|
| Receipt number | R000045984 |
| Scientific Title | feasibility and safety of rectal tumor resection under transanal endoscopic surgery using a soft anal platform |
| Date of disclosure of the study information | 2020/05/04 |
| Last modified on | 2020/05/04 08:48:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
feasibility and safety of rectal tumor resection under transanal endoscopic surgery using a soft anal platform
Acronym
feasibility and safety of rectal tumor resection under transanal endoscopic surgery using a soft anal platform
Scientific Title
feasibility and safety of rectal tumor resection under transanal endoscopic surgery using a soft anal platform
Scientific Title:Acronym
feasibility and safety of rectal tumor resection under transanal endoscopic surgery using a soft anal platform
Region
| Japan |
Condition
Condition
rectal neoplasma
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
feasibility and safety of rectal tumor resection under transanal endoscopic surgery using a soft anal platform
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complications
Key secondary outcomes
operative bleeding, operation time, recurrence rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
rectal tumor (adenoma, adenocarcinoma Tis T1a T1b, NET)
Key exclusion criteria
T2,T3,T4 tumor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shigeoki |
| Middle name | Hayashi |
| Last name | Hayashi |
Organization
Nihon University, school of medicine
Division name
Digestive Surgery
Zip code
101-8309
Address
1-6 kandasurugadai, chiyoda-ku, tokyo, Japan
TEL
0332931711
hayashi.shigeoki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeoki |
| Middle name | Hayashi |
| Last name | Hayashi |
Organization
Nihon University, school of medicine
Division name
Digestive Surgery
Zip code
101-8309
Address
1-6 kandasurugadai, chiyoda-ku, tokyo, Japan
TEL
0332931711
Homepage URL
hayashi.shigeoki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University, school of medicine
Digestive Surgery
Institute
Department
Personal name
Funding Source
Organization
self
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Hospital IRB
Address
1-6 kandasurugadai, chiyoda-ku, tokyo, Japan
Tel
0332931711
hayashi.shigeoki@nihon-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
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
Main results already published
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2010 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recently this study shows that rectal tumor resection under transanal endoscopic surgery using a soft anal platform is safety and feasible.
Management information
Registered date
| 2020 | Year | 05 | Month | 04 | Day |
Last modified on
| 2020 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045984
