UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022278
Receipt number R000025670
Scientific Title Laparoscopic radical hysterectomy using robotic surgical system (da Vinci Surgical System; DVSS)
Date of disclosure of the study information 2016/05/11
Last modified on 2020/02/16 13:49:22

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Basic information

Public title

Laparoscopic radical hysterectomy using robotic surgical system (da Vinci Surgical System; DVSS)

Acronym

Robot-assisted radical hysterectomy

Scientific Title

Laparoscopic radical hysterectomy using robotic surgical system (da Vinci Surgical System; DVSS)

Scientific Title:Acronym

Robot-assisted radical hysterectomy

Region

Japan


Condition

Condition

cervical cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The object of this Study is to assess the efficacy and safety of robotic-assisted radical hysterectomy using DVSS for cervical cancer patient that can be curative. This Study is designed as the Advanced Medical Treatment/Technology Assessment Program B to provide the Clinical Study Report (CSR) based on the primary analysis, for the purpose of regulatory submission to MHLW for the national health insurance technology price listing.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

success operation with a little blood loss

Key secondary outcomes

the operation time, the console time, No. of lymph nodes resected, the appropriateness of extracted specimen, the ratio of blood transfusion, the reserve ratio of autologous blood, the urinary function, the success rate of robot-assisted radical hysterectomy, the rate of conversion to laparotomy, postoperative courses (onset of postoperative oral ingest, duration of postoperative hospital stay), postoperative QOL measured by EQ-5D, overall survival, relapse-free survival, the occurrence of perioperative adverse events, the occurrence of postoperative adverse events, the occurrence of late adverse events, the defect failure of DVSS


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

Device,equipment

Interventions/Control_1

use of the robot for endoscopic 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

18 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

cervical cancer (squamous cell carcinoma FIGO Stages IB1 - llB , or adenocarcinoma FIGO Stages IA2 - IIB without metastasis of lymph nodes and intracorporeal organs)

Key exclusion criteria

1) patients having an active double cancer
2) a woman who become pregnant or may become pregnant, or a nursing woman
3) patients with mental disorders
4) morbid obese patients (Body Mass Index: BMI >= 35)
5) patients received neoadjuvant chemotherapy
6) patients that it was judged that it was inadequate to participate in this study due to others

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Keiichi
Middle name
Last name Isaka

Organization

Tokyo Medical University Hospital

Division name

Department of Obstetrics and Gynecology

Zip code

160-0023

Address

6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo

TEL

03-3342-6111

Email

isaka@tokyo-med.ac.jp


Public contact

Name of contact person

1st name Kaori
Middle name
Last name Nakamichi

Organization

Tokyo Medical University Hospital

Division name

Department of Obstetrics and Gynecology

Zip code

160-0023

Address

6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo

TEL

03-3342-6111

Homepage URL


Email

n-kaori@tokyo-med.ac.jp


Sponsor or person

Institute

Tokyo Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

Tokyo Medical University Hospital

Address

6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo

Tel

03-3351-6141

Email

d-irinri@tokyo-med.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

2016 Year 05 Month 11 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

100

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

2016 Year 04 Month 05 Day

Date of IRB

2015 Year 12 Month 08 Day

Anticipated trial start date

2016 Year 06 Month 01 Day

Last follow-up date

2024 Year 12 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

2016 Year 05 Month 11 Day

Last modified on

2020 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025670


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/02/16 UMIN登録用20200216提出データ-2.xlsx