UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the efficacy and safty of trns anal minimally invasive surgery for rectal cancer
Title of the study (Brief title)	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	Naohiro Tomita
Organization	Hyogo College of Medicine
Division name	Division of Lower GI Surgery, Department of Surgery
Address	1-1Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6372
Email	ntomita@hyo-med.ac.jp

Public contact
Name of contact person	Kiyoshi Tsukamoto
Organization	Hyogo College of Medicine
Division name	Division of Lower GI Surgery, Department of Surgery
Address	1-1Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6372
Homepage URL
Email	tsuka25@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033201