UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040371 |
|---|---|
| Receipt number | R000046060 |
| Scientific Title | Efficacy of safety of Natural Orifice Specimen Extraction:NOSE for Colorectal cancer |
| Date of disclosure of the study information | 2020/07/08 |
| Last modified on | 2021/11/15 11:28:16 |
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Basic information
Public title
Efficacy of safety of Natural Orifice Specimen Extraction:NOSE for Colorectal cancer
Acronym
Efficacy of safety of Natural Orifice Specimen Extraction:NOSE for Colorectal cancer
Scientific Title
Efficacy of safety of Natural Orifice Specimen Extraction:NOSE for Colorectal cancer
Scientific Title:Acronym
Efficacy of safety of Natural Orifice Specimen Extraction:NOSE for Colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and the usefulness of
Natural Orifice Specimen Extraction:NOSE for cololectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
assessment of abdominal pain
Key secondary outcomes
Age, gender, BMI (Body Mass Index), comorbidity (eg, diabetes mellitus), sudden cessation of drugs (eg, steroids), intestinal obstruction, operation time, intraoperative blood loss, T factor, N factor, M factor, distance of anastomotic site from anal verge, rate of leakage, rate of intraperitoneal abscess, ate of bleeding after surgery, rate of interventional drainage, rate of relaparotomy, rate of stoma creation, SSI, rate of morbidity, length of drain insertion, hospital stay, mortality, rate of readmission, assessment of the QOL
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
Natural Orifice Specimen Extraction:NOSE
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing colorectal surgery for cStage 0 or I (location: C, A, T, D, S and RS)
Key exclusion criteria
1)Patients with or suspicious of estrogen-dependent cancer (eg, breast cancer or gynecologic canbcer)
2)Participants with a history of any hypersensitivity to ingredients in HOLIN-V VAGINAL TABLETS
3)Patients who have the possibility of being pregnant
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Hamamoto |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department General and Gastroenterological Surgery
Zip code
569-8686
Address
Takatsuki
TEL
0726831221
hiroki.hamamoto@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Hamamoto |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department General and Gastroenterological Surgery
Zip code
569-8686
Address
Takatsuki
TEL
0726831221
Homepage URL
hiroki.hamamoto@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Osaka Medical and Pharmaceutical University Institutional Review Board
Address
2-7, Daigakumachi
Tel
0726831221
rinri@osaka-med.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 | 07 | Month | 08 | 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
| 2020 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 08 | 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
Management information
Registered date
| 2020 | Year | 05 | Month | 11 | Day |
Last modified on
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046060
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
