UMIN-CTR Clinical Trial

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
Email	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
Email	wataru.osumi@ompu.ac.jp

Sponsor
Institute	Osaka Medical and Pharmaceutical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030473