UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024672
Receipt number R000028382
Scientific Title The efficacy and safety of laproscopic radical hysterectomy
Date of disclosure of the study information 2016/11/01
Last modified on 2017/11/08 12:56:48

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Basic information

Public title

The efficacy and safety of laproscopic radical hysterectomy

Acronym

Laproscopic radical hysterectomy

Scientific Title

The efficacy and safety of laproscopic radical hysterectomy

Scientific Title:Acronym

Laproscopic 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 safety and efficacy 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


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

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

cervical cancer
stage IA2,IB1,IIA1

Key exclusion criteria

Severe comorbidity
patients judged inappropriate for this study by the physician

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihiko Wakatsuki

Organization

Aichi medical university

Division name

Obstetrics and Gynecology

Zip code


Address

1-1 Yazakokarimata,Nagakute,Aichi

TEL

0561-62-3311

Email

obgyn@aichi-med-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noguchi Yasuyuki

Organization

Aichi medical university

Division name

Obstetrics and Gynecology

Zip code


Address

1-1 Yazakokarimata,Nagakute,Aichi

TEL

0561-62-3311

Homepage URL


Email

obgyn@aichi-med-u.ac.jp


Sponsor or person

Institute

Aichi medical university

Institute

Department

Personal name



Funding Source

Organization

Aichi 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


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

2016 Year 11 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

Completed

Date of protocol fixation

2016 Year 08 Month 31 Day

Date of IRB


Anticipated trial start date

2016 Year 11 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



Management information

Registered date

2016 Year 11 Month 01 Day

Last modified on

2017 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028382


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name