UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029039
Receipt number R000033201
Scientific Title A study of the efficacy and safty of trns anal minimally invasive surgery for rectal cancer
Date of disclosure of the study information 2017/12/01
Last modified on 2017/09/07 11:25:52

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Basic information

Public title

A study of the efficacy and safty of trns anal minimally invasive surgery for rectal cancer

Acronym

A study of the efficacy and safty of trns anal minimally invasive surgery for rectal cancer

Scientific Title

A study of the efficacy and safty of trns anal minimally invasive surgery for rectal cancer

Scientific Title:Acronym

A study of the efficacy and safty of trns anal minimally invasive surgery for rectal cancer

Region

Japan


Condition

Condition

rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safty of trans anal minimally invasive surgery for rectal cancer in prospective study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse event rate

Key secondary outcomes

Rate of surgivcal resectin margin, Rocal recurence rate


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 Maneuver

Interventions/Control_1

A group: We perform radical resection for rectal cancer(including primary and rocal recurence tumor) by using laparoscopic and trans anal minimally invasive surgery method. We performe 5 years follow-up for the patients after the operation.

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)Patients expected to undergo radical excision for primary or rocal recurence rectal cancer
2)Written informed consent

Key exclusion criteria

1)Case of emergency operation
2)Patients who would not complete this study by psychotic conditions
3)Patients who would not complete this study according to surgeon's decision

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naohiro Tomita

Organization

Hyogo College of Medicine

Division name

Division of Lower GI Surgery, Department of Surgery

Zip code


Address

1-1Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6372

Email

ntomita@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kiyoshi Tsukamoto

Organization

Hyogo College of Medicine

Division name

Division of Lower GI Surgery, Department of Surgery

Zip code


Address

1-1Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6372

Homepage URL


Email

tsuka25@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hyogo College of Medicine

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


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

2017 Year 12 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

Preinitiation

Date of protocol fixation

2017 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 12 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

2017 Year 09 Month 07 Day

Last modified on

2017 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=R000033201


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name