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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040371
Receipt No. 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 2020/05/11

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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 Masashi
Middle name
Last name Yamamoto
Organization Osaka Medical Collage
Division name Department General and Gastroenterological Surgery
Zip code 569-8686
Address Takatsuki
TEL 0726831221
Email sur138@osaka-med.ac.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Yamamoto
Organization Osaka Medical Collage
Division name Department General and Gastroenterological Surgery
Zip code 569-8686
Address Takatsuki
TEL 0726831221
Homepage URL
Email sur138@osaka-med.ac.jp

Sponsor
Institute Osaka Medical Collage
Institute
Department

Funding Source
Organization Osaka Medical Collage
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 Collage Institutional Review Board
Address 2-7, Daigakumachi
Tel 0726831221
Email 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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 11 Day
Date of IRB
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
2020 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046060

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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