UMIN-CTR Clinical Trial

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
Email	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
Email	hiroki.hamamoto@ompu.ac.jp

Sponsor
Institute	Osaka Medical and Pharmaceutical University
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046060