UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Study of Reduced Port Surgery Combined with Transvaginal Specimen Extraction for Colorectal Cancer Resection
Acronym	Prospective Study of Reduced Port Surgery Combined with Transvaginal Specimen Extraction for Colorectal Cancer Resection
Scientific Title	Prospective Study of Reduced Port Surgery Combined with Transvaginal Specimen Extraction for Colorectal Cancer Resection
Scientific Title:Acronym	Prospective Study of Reduced Port Surgery Combined with Transvaginal Specimen Extraction for Colorectal Cancer Resection
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of Reduced Port Surgery combined with transvaginal specimen extraction for colorectal cancer resection in multicenter prospective study
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Reduced Port Surgery Combined with Transvaginal Specimen Extraction for Colorectal Cancer Resection
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	Female
Key inclusion criteria	(1) colorectal cancer patients undergoing elective surgery (2) histologically proven colorectal carcinoma (3) tumor located in the sigmoid colon or rectosigmoid colon (4) Stage 0-I, according to the TNM classification system (5) age >= 20 and <= 80 years, no willing to bear children, previous childbirth with vaginal delivery (6) without any gynecological comorbidities need to be treated (7) vaginal examination shows no inadequate conditions for transvaginal specimen extraction such as stenosis of vagina (8) no history of diseases which could cause pelvic adhesion such as pelvic peritonitis (9) PS (ECOG) 0 or 1 (10) no history of gastrointestinal resection (except appendectomy) (11) no history of chemotherapy or radiotherapy for other cancers (12) no preoperative chemotherapy or radiotherapy (13) with a good condition of important organs 1. WBC : >= 3,000/mm3 2. platelet >= 100,000/mm3 3. serum creatinine <= 1.5mg/dL 4. ALT/AST <= 5-times the upper limit of normal in facility criteria (14) provided written informed consent
Key exclusion criteria	(1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ (2) with uncontrolled diabetes mellitus (including the case requiring insulin administration) (3) with uncontrolled congestive heart disease, ischemic heart disease, hypertension or arhythmia (4) severe mental disease (5) not appropriate for the study at the physician's assessment
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Takemasa
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Gastroenterological Surgery
Zip code	565-0871
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3251
Email	itakemasa@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Hamabe
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Gastroenterological Surgery
Zip code	565-0871
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3251
Homepage URL
Email	ahamabe@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University
Institute
Department

Funding Source
Organization	National Cancer Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Cancer Center Hospital East Osaka Medical College, Department of General and Gastrocnterological Surgery Shinko Hospital Tonan Hospital Nagaoka Chuo General Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University, Graduate School of Medicine
Address	2-2 Yamadaoka, Suita, Osaka
Tel	06-6210-8290
Email	jim-chiken@hp.crc.med.osaka-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	2015 Year 03 Month 21 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	Completed
Date of protocol fixation	2014 Year 02 Month 20 Day
Date of IRB	2014 Year 05 Month 12 Day
Anticipated trial start date	2014 Year 05 Month 12 Day
Last follow-up date	2022 Year 09 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 21 Day
Last modified on	2022 Year 09 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016113