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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024862
Receipt No. R000028612
Scientific Title Efficacy of transanal tube for the prevention of anastomotic leakage after rectal cancer surgery: A multicenter prospective randomized controlled trial
Date of disclosure of the study information 2016/11/16
Last modified on 2016/11/16

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Basic information
Public title Efficacy of transanal tube for the prevention of anastomotic leakage after rectal cancer surgery: A multicenter prospective randomized controlled trial
Acronym Efficacy of transanal tube for the prevention of anastomotic leakage after rectal cancer surgery: A multicenter prospective randomized controlled trial
Scientific Title Efficacy of transanal tube for the prevention of anastomotic leakage after rectal cancer surgery: A multicenter prospective randomized controlled trial
Scientific Title:Acronym Efficacy of transanal tube for the prevention of anastomotic leakage after rectal cancer surgery: A multicenter prospective randomized controlled trial
Region
Japan

Condition
Condition Rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate the efficacy and safety of transanal tube for the prevention of anastomotic leakage after rectal surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Anastomotic leakage after rectal surgery
Key secondary outcomes 30-day morbidity and mortality postoperatively

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The transanal tube is inserted into the anus.
Interventions/Control_2 The transanal tube is not inserted into the anus.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria were biopsy-proven carcinoma of the rectum located within 15cm above the anal verge, age above 20 years, informed consent and ability to understand the study information.
Key exclusion criteria Exclusion criteria included informed consent not possible, declined consent and uncntorolable managemment of the transanal tube.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Matsuda
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1, Kimiidera, Wakayama city, Wakayama, Japan
TEL 073-441-0613
Email kmatsuda@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Matsuda
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1, Kimiidera, Wakayama city, Wakayama, Japan
TEL 073-441-0613
Homepage URL
Email kmatsuda@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
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 和歌山県立医科大学附属病院(和歌山県),国立病院機構大阪南医療センター(大阪府),泉大津市立病院(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 16 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
2016 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 02 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
2016 Year 11 Month 16 Day
Last modified on
2016 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028612

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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