UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027713 |
|---|---|
| Receipt number | R000031731 |
| Scientific Title | Laparoscopic radical hysterectomy for early stage cervical cancer |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2023/12/14 12:00:07 |
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Basic information
Public title
Laparoscopic radical hysterectomy for early stage cervical cancer
Acronym
Laparoscopic radical hysterectomy
Scientific Title
Laparoscopic radical hysterectomy for early stage cervical cancer
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
Evaluation of the feasibility, safety, efficacy and oncological outcome of laparoscopic radical hysterectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological evaluation of resection margin
Three year disease-free survival
Key secondary outcomes
Disease-free survival, three and five year survival, operation time, blood loss, blood transfusion rate, intraoperative complications, postoperative complications, postoperative quality of life
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 pelvic lymph node dissection
2)laparoscopic nerve-sparing 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)cervical cancer stage IA2,IB1,IIA1
2)with written informed consent
Key exclusion criteria
1)huge leiomyoma or adenomyosis
2)severe comorbidity
3)performance status 3 and 4
4)patients judged inappropriate for this study by the physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Sekiyama |
Organization
Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name
Obstetrics and Gynecology
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
TEL
06-6312-8831
k-sekiyama@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Kentaro |
Organization
Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name
Obstetrics and Gynecology
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
TEL
06-6312-8831
Homepage URL
k-sekiyama@kitano-hp.or.jp
Sponsor or person
Institute
Tazuke Kofukai Medical Research Institute Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
Tazuke Kofukai Medical Research Institute Kitano Hospital
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
Tazuke Kofukai Medical Research Institute Kitano Hospital
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
Tel
06-6312-8831
rinshou@kitano-hp.or.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
| 2017 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2017 | Year | 06 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031731
