UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009605
Receipt number R000011040
Scientific Title The safety and efficacy of laparoscopic surgery for endometrial cancer.
Date of disclosure of the study information 2013/04/01
Last modified on 2013/09/18 12:13:57

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Basic information

Public title

The safety and efficacy of laparoscopic surgery for endometrial cancer.

Acronym

The safety and efficacy of laparoscopic surgery for endometrial cancer.

Scientific Title

The safety and efficacy of laparoscopic surgery for endometrial cancer.

Scientific Title:Acronym

The safety and efficacy of laparoscopic surgery for endometrial cancer.

Region

Japan


Condition

Condition

endometrial cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the safety and efficacy of laparoscopy for endometrial cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

operation time, complication, recovery period, postoperative pain, prognosis

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

trial period:2013/4/1-2018/3/31

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

80 years-old >=

Gender

Female

Key inclusion criteria

1. endometrial cancer stage 1
2. ECOG-PS 0-1

Key exclusion criteria

1.severe cardio-or cerebro-vascular disease.
2.after radiation therapy in pelvic cavity.
3.severe renal failure.
4.severe liverfailure.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Minoru Irahara

Organization

Tokushima university hospital

Division name

Ogstericl and Gynecology

Zip code


Address

2-50-1, Kuramoto-cho, Tokushima city

TEL

088-633-7177

Email

irahara@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Kato

Organization

Tokushima university Hospital

Division name

Obsterics and Gynecology

Zip code


Address

3-18-15, Kuramoto-cho Tokushima city

TEL

088-633-7177

Homepage URL


Email

kato@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima university Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokushima university 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


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

2013 Year 04 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

Open public recruiting

Date of protocol fixation

2013 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 04 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

2012 Year 12 Month 21 Day

Last modified on

2013 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011040


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name