UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039685
Receipt number R000045179
Scientific Title Investigation of the effect of robot-assisted surgery for advanced rectal cancer on oncological feasibility: Multicenter, Prospective, Phase II study
Date of disclosure of the study information 2020/03/04
Last modified on 2022/09/07 21:50:54

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Basic information

Public title

Investigation of the effect of robot-assisted surgery for advanced rectal cancer on oncological feasibility: Multicenter, Prospective, Phase II study

Acronym

VITRUVIANO trial

Scientific Title

Investigation of the effect of robot-assisted surgery for advanced rectal cancer on oncological feasibility: Multicenter, Prospective, Phase II study

Scientific Title:Acronym

VITRUVIANO trial

Region

Japan


Condition

Condition

advanced rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the oncological feasibility on robot-assisted surgery for advanced rectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Proportion of CRM-negative

Key secondary outcomes

Quality of TME
successful resection (CRM-negative, DM-negative and complete TME)
Conversion to open surgery
Intraoperative adverse effects
Surgical outcomes (estimate blood loss, operative time, console time, number of lymph nodes harvested)
Postoperative recovery of bowel function (time to first flatus/ stools/ intake of fluid and diet)
Postoperative urinary function (residual urine volume/ I-PSS/ OABSS/ ICIQ-SF)
Length of postoperative hospital stay
Postoperative complications within 30 days after surgery (Clavien-Dindo classification grade III or more)
Surgery-related mortality within 30 days after surgery
Reoperation within 30 days after surgery
3-year local recurrence-free survival
3-year disease-free survival
3-year overall survival


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

Male and Female

Key inclusion criteria

1) Histologically diagnosed with rectal cancer
2) Diagnosed operable by preoperative examination and image diagnosis method
3) Tumor lower margin is less than or equal to 12 cm from the anal verge
4) Tumor location is rectosigmoid (RS), upper rectum (Ra), lower rectum (Rb), proctodeum (P)
5) "cT2-T4a and cN0-N3 and cM0" or "cT1-T4a and cN1-N3 and cM0" (Evaluate before preoperative treatment if patients will undergo preoperative treatment)
6) Diagnosed as not applicable for endoscopic resection
7) Scheduled for robot-assisted rectal resection in routine medical care (Informed consent has been obtained)
8) 20 years or older
9) Written informed consent for participation in this study has been obtained

Key exclusion criteria

1) cT4b
2) Multiple rectal cancer (except Tis)
3) Multiple malignancies
4) Patients whose consent ability is judged to be insufficient (dementia etc.)
5) Other, patients judged inappropriate by investigators

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Ichiro
Middle name
Last name Takemasa

Organization

Sapporo Medical University Hospital

Division name

Department of surgery, surgical oncology and science

Zip code

060-8543

Address

291, South1 West16, Chuo-ku, Sapporo, Hokkaido

TEL

011-611-2111

Email

itakemasa@sapmed.ac.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Hamabe

Organization

Sapporo Medical University Hospital

Division name

Department of surgery, surgical oncology and science

Zip code

060-8543

Address

291, South1 West16, Chuo-ku, Sapporo, Hokkaido

TEL

011-611-2111

Homepage URL


Email

ahamabe@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University Hospital
Department of surgery, surgical oncology and science

Institute

Department

Personal name



Funding Source

Organization

Intuitive Surgical, Sarl

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sapporo medical university hospital institutional review board

Address

291, South1 West16, Chuo-ku, Sapporo, Hokkaido

Tel

011-611-2111

Email

ji-rskk@sapmed.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

札幌医科大学附属病院(北海道)、岩手医科大学附属病院(岩手県)、厚生連高岡病院(富山県)、東京都立駒込病院(東京都)、東京医科歯科大学医学部附属病院(東京都)、順天堂大学医学部附属順天堂医院(東京都)、国立がん研究センター中央病院(東京都)、がん研有明病院(東京都)、横浜市立大学附属病院(神奈川県)、横浜市立大学附属市民総合医療センター(神奈川県)、静岡県立静岡がんセンター(静岡県)、藤田医科大学病院(愛知県)、名古屋大学医学部附属病院(愛知県)、大阪大学医学部附属病院(大阪府)、近畿大学病院(大阪府)、兵庫医科大学病院(兵庫県)、福岡大学病院(福岡県)、大分大学医学部附属病院(大分県)


Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 04 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

2020 Year 01 Month 15 Day

Date of IRB

2020 Year 02 Month 13 Day

Anticipated trial start date

2020 Year 03 Month 09 Day

Last follow-up date

2024 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective study
Assessment for CRM negative rate


Management information

Registered date

2020 Year 03 Month 04 Day

Last modified on

2022 Year 09 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045179


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name