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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026534
Receipt No. R000030473
Scientific Title A clinical trial of a criteria for transanal drainage tube removal after low anterior resection [Trans Anal Drainage tube Trial (TAD trial)]
Date of disclosure of the study information 2017/03/13
Last modified on 2018/03/14

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Basic information
Public title A clinical trial of a criteria for transanal drainage tube removal after low anterior resection
[Trans Anal Drainage tube Trial (TAD trial)]
Acronym TAD trial
Scientific Title A clinical trial of a criteria for transanal drainage tube removal after low anterior resection
[Trans Anal Drainage tube Trial (TAD trial)]
Scientific Title:Acronym TAD trial
Region
Japan

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

Objectives
Narrative objectives1 The purposes of this study is to evaluate the usefulness of a trans anal drainage tube for the prevention of anastomotic leakage and the criteria for transanal drainage tube removal after low anterior resection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of leakage
Key secondary outcomes Age, gender, BMI, comorbidity, preoperative steroids, intestinal obstruction, operation time, intraoperative blood loss, years of experience of surgeons, T factor, N factor, M factor, lymphadenectomy of lateral lymph nodes, distance of anastomotic site from anal verge, rate of bleeding after surgery, rate of intraperitoneal abscess, rate of interventional drainage, rate of relaparotomy, rate of stoma creation, SSI, rate of morbidity, length of drain insertion, hospital stay, mortality, rate of readmission

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The transanal drainage tube is placed for gravity drainage and kept in place for 3 days after surgery.
Interventions/Control_2 The transanal drainage tube is placed for gravity drainage and kept in place for 5 days after surgery.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing low anterior resection, super low anterior resection or intersphincteric resection for rectal diseases
Key exclusion criteria 1)Emergency case
2)Patients with severe comorbidity
3)Patients with organ dysfunction
4)Patients recived preoperative chemotherapy and/or oradiotherapy
5)Bowel obstruction or stenosis case
Target sample size 224

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Yamamoto
Organization Osaka Medical Collage
Division name Departments of General and Gastroenterological Surgery
Zip code
Address 2-7 daigakumachi, Takatsuki city
TEL 072-683-1221
Email sur138@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Yamamoto
Organization Osaka Medical Collage
Division name Departments of General and Gastroenterological Surgery
Zip code
Address 2-7 daigakumachi, Takatsuki city
TEL 072-683-1221
Homepage URL
Email sur138@osaka-med.ac.jp

Sponsor
Institute Osaka Medical Collage
Institute
Department

Funding Source
Organization Osaka Medical Collage
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 03 Month 13 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 14 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 03 Month 13 Day
Last modified on
2018 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030473

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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