UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016859 |
|---|---|
| Receipt number | R000016113 |
| Scientific Title | Prospective Study of Reduced Port Surgery Combined with Transvaginal Specimen Extraction for Colorectal Cancer Resection |
| Date of disclosure of the study information | 2015/03/21 |
| Last modified on | 2022/09/07 21:48:23 |
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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
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
ahamabe@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016113
