UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015312
Receipt number R000017274
Scientific Title the study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci S surgical system
Date of disclosure of the study information 2014/11/01
Last modified on 2021/10/06 09:34:47

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Basic information

Public title

the study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci S surgical system

Acronym

the study of utility and safety for robot-assisted laparoscopic radical hysterectomy

Scientific Title

the study of utility and safety for robot-assisted laparoscopic radical hysterectomy using da Vinci S surgical system

Scientific Title:Acronym

the study of utility and safety for robot-assisted laparoscopic radical hysterectomy

Region

Japan


Condition

Condition

Uterine Cervical cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

"da Vinci S Surgical System" as robot assisted surgery device is safe, minimally invasive and stressless, so is suitable for complicated and delicate operation as radical hysterectomy. Our purpose of this study is to assess the utility and safety of this system for robot assisted laparoscopic radical hysterectomy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

1. Intra-operative & post-operative complications

Key secondary outcomes

1. blood loss
2. the level of postoperative pain
3. the numaber of retrieved lymphnodes
4. operative time


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

Device,equipment

Interventions/Control_1

We perform robot assisted 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 Uterine cervical cancer, stage IA2-IIB (FIGO criteria)
#2 Good general status (Performance status 0-1)

Key exclusion criteria

#1 With double cancers
#2 With a history of pelvic radiotherapy
#3 With a history of a surgery in the pelvis
#4 Intolerant of general anesthesia
#5 Undergoing chemotherapy
#6 In pregnancy

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Hideki
Middle name
Last name Tokunaga

Organization

Tohoku University Hospital

Division name

Gynecology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7254

Email

tokunagahideki@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Zen
Middle name
Last name Watanabe

Organization

Tohoku University

Division name

Gynecology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7254

Homepage URL


Email

zenw5261@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



Funding Source

Organization

Tohoku University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee Tohoku University Hospital

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

Tel

022-728-4105

Email

rinri-2@proj.med.tohoku.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



Other administrative information

Date of disclosure of the study information

2014 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

Enrolling by invitation

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB

2014 Year 09 Month 16 Day

Anticipated trial start date

2014 Year 11 Month 01 Day

Last follow-up date

2023 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

2014 Year 10 Month 01 Day

Last modified on

2021 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017274


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name