UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026534 |
|---|---|
| Receipt number | 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 | 2021/09/16 15:27:39 |
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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 | Wataru |
| Middle name | |
| Last name | Osumi |
Organization
Osaka Medical and Pharmaceutical University
Division name
Departments of General and Gastroenterological Surgery
Zip code
569-8686
Address
Takatsuki
TEL
072-683-1221
wataru.osumi@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Osumi |
Organization
Osaka Medical and Pharmaceutical University
Division name
Departments of General and Gastroenterological Surgery
Zip code
569-8686
Address
Takatsuki
TEL
072-683-1221
Homepage URL
wataru.osumi@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical 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
Osaka Medical and Pharmaceutical University Institutional Review Board
Address
2-7, Daigakumachi
Tel
072-683-1221
rinri@osaka-med.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
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
| 2019 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
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
| 2021 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030473
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
