UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016501 |
|---|---|
| Receipt number | R000019161 |
| Scientific Title | Laparoscopic radical hysterectomy |
| Date of disclosure of the study information | 2015/02/10 |
| Last modified on | 2022/08/17 19:37:23 |
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Basic information
Public title
Laparoscopic radical hysterectomy
Acronym
Laparoscopic radical hysterectomy
Scientific Title
Laparoscopic radical hysterectomy
Scientific Title:Acronym
Laparoscopic radical hysterectomy
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility, safety and oncological outcome of the laparoscopic radical hysterectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of resected specimen
3 yr disease free survival
Key secondary outcomes
Diesease free survival
3,5yr survival
operation time
blood loss
transfuseon rate
intra-postoperative complication
post operative quality of life compared with the laparotomy
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
surgery
Laparoscopic radical hysterectomy
& pelvic lymphadenectomy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) cervical cancer
stage IA2,IB1,IIA1
Key exclusion criteria
1) huge leiomyoma or adenomayosis
2) severe comorbidity
3) performance status 3.4
4) patients judged inappropriate for this study by the physician
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Kita |
Organization
Kansai Medical University
Division name
Obstetrics and Gynecology
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata Osaka 573-1010
TEL
0728040101
kitamas@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Kita |
Organization
Kansai Medical University
Division name
Obstetrics and Gynecology
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata Osaka 573-1010
TEL
072-804-0101
Homepage URL
kitamas@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical 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
Kansai Medical University
Address
Shinmachi 2-5-1, HIrakata City, Osaka, Japan
Tel
072-804-0101
kitamas@hirakata.kmu.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
関西医科大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
3
Results
no complications
Results date posted
| 2021 | Year | 10 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
not paricular
Participant flow
as scheduled
Adverse events
none
Outcome measures
no abnormal findings
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 10 | Day |
Last modified on
| 2022 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019161
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
