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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013229
Receipt No. R000015439
Scientific Title An investigation of the safety and efficacy of robot-assisted laparoscopic surgery for cervical and uterine cancer
Date of disclosure of the study information 2014/03/01
Last modified on 2015/09/25

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Basic information
Public title An investigation of the safety and efficacy of robot-assisted laparoscopic surgery for cervical and uterine cancer
Acronym Robot-assisted laparoscopic surgery for cervical and uterine cancer
Scientific Title An investigation of the safety and efficacy of robot-assisted laparoscopic surgery for cervical and uterine cancer
Scientific Title:Acronym Robot-assisted laparoscopic surgery for cervical and uterine cancer
Region
Japan

Condition
Condition cervical cancer and uterine cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate the safety and efficacy of robot-assisted laparoscopic surgery for cervical and uterine cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Operation time, console time, blood loss, intra-operative/post-operative complications will be recorded, which will be compared to those of open surgery for cervical and uterine cancers.
Key secondary outcomes Histopathological completeness of surgery, number of lymph nodes harvested, post-operative bladder function, 5-year recurrence free survival and the site of recurrence.

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
Device,equipment
Interventions/Control_1 Patients with cervical cancer or uterine cancer, who are eligible for radical surgery and provide voluntary consent by signing the written informed consent documents, will undergo robot-assisted radical surgery. Their peri-operative courses will be closely observed and the primary and secondary outcome measures will be investigated. Post-operative bladder function will be examined at 3, 6, and 12 months after surgery. Recurrence will be checked for 5 years after surgery.
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

Not applicable
Gender Female
Key inclusion criteria 1. Women who are 20 years old at the time of giving informed consent.
2. Patient with clinical stage I &#8211; II cervical cancer or patients who are supposed to have surgical stage I &#8211; III uterine cancer (cervical cancer is staged before treatment and uterine cancer is staged after surgery by histo-pathological examination).
3.PS: 0 &#8211; 1
4. Patients who have been given information and who have discussed the risks, benefits and other aspects of the trial with principal investigator and who provide voluntary consent by signing the written informed consent documents.
Key exclusion criteria 1. Patient with cervical or uterine cancer with specific subtype of undifferentiated carcinoma, small cell carcinoma, clear cell adenocarcinoma, glassy cell carcinoma.
2. Patients who are judged to be not eligible for the study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriaki Sakuragi
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gynecology
Zip code
Address Kita15, Nishi7 Kita-ku, Sapporo 060- 8638 Japan
TEL 011-706-5938
Email sakuragi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriaki Sakuragi
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gynecology
Zip code
Address Kita15, Nishi7 Kita-ku, Sapporo 060- 8638 Japan
TEL 011-706-5938
Homepage URL
Email sakuragi@med.hokudai.ac.jp

Sponsor
Institute Department of Gynecology, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization Hokkaido University Hospital and the Department of Gynecology, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 03 Month 01 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
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 23 Day
Last modified on
2015 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015439

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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