UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016020 |
|---|---|
| Receipt number | R000018627 |
| Scientific Title | The efficacy and eligibility of laparoscopic radical hysterectomy for early stage uterine cervical cancers |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2018/08/11 06:50:11 |
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Basic information
Public title
The efficacy and eligibility of laparoscopic radical hysterectomy for early stage uterine cervical cancers
Acronym
Laparoscopic radical hysterectomy
Scientific Title
The efficacy and eligibility of laparoscopic radical hysterectomy for early stage uterine cervical cancers
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
Assess the efficacy and safety of laparoscopic radical hysterectomy to compare the following outcomes with conventional surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood loss, blood transfusion, discharge date, postoperative complications such as ileus, SSI, and pain, surgical completion
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1. laparoscopic PEN
2. followed by laparoscopic radical hysterectomy
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1)cervical cancer stage IA2, IB1, and IIA1
2)with written informed consent
Key exclusion criteria
1. anyone who does not satisfy inclusion criteria
2. PS>2, or with severe complications
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo KONISHI |
Organization
Kyoto University Graduate School of Medicine
Division name
Gynecology and Obstetrics
Zip code
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL
075-751-3269
babatsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsukasa BABA |
Organization
Kyoto University Graduate School of Medicine
Division name
Gynecology and Obstetrics
Zip code
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL
075-751-3269
Homepage URL
babatsu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
京都大学医学部附属病院(京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
LRH has been covered with health insurance since April 2018.
Management information
Registered date
| 2014 | Year | 12 | Month | 22 | Day |
Last modified on
| 2018 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018627
