UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011374 |
|---|---|
| Receipt number | R000013321 |
| Scientific Title | The evaluation for safety and usefulness of the robotic assisted laparoscopic total or radical hysterectomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy |
| Date of disclosure of the study information | 2013/08/05 |
| Last modified on | 2017/02/06 11:39:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The evaluation for safety and usefulness of the robotic assisted laparoscopic total or radical hysterectomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy
Acronym
The evaluation for safety and usefulness of the robotic surgery for uterine cancer
Scientific Title
The evaluation for safety and usefulness of the robotic assisted laparoscopic total or radical hysterectomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy
Scientific Title:Acronym
The evaluation for safety and usefulness of the robotic surgery for uterine cancer
Region
| Japan |
Condition
Condition
Uterine cervical or corpus cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is the evaluation for safety of the robotic surgery for uterine cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Operation time, blood loss, the number of lymph nodes, complications, postsurgical pain, hemoglobin concentration, the levels of serum CRP
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Robotic assisted laparoscopic total or radical hysterectomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy
Interventions/Control_2
Abdominal total or radical hysterectomy with bilateral salpingo-oophorectomy and pelvic lymphadenectomy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Low-recurrent risk uterine corpus cancer (FIGO IA and endometrioid adenocarcinoma, G1 or G2) that requires surgery or uterine cervical cancer (FIGO IA2 or IB1)
Key exclusion criteria
Inappropriate cases for laparoscopic surgeries due to severe endometriosis, large uterine leiomyoma, severe obesity, severe intraabdominal adhesion and other factors
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Iwase |
Organization
Nagoya University Graduate School of Medicine
Division name
Maternal and Perinatal Medicine
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2261
akiwase@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Iwase |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2261
Homepage URL
akiwase@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 08 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2013 | Year | 08 | Month | 05 | Day |
Last modified on
| 2017 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013321
