UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027455
Receipt No. R000031452
Scientific Title Phase 2 study of safety and efficacy of a transanal tube (WING DRAIN) for the prevention of anastomotic leakage after rectal cancer surgery.
Date of disclosure of the study information 2017/07/01
Last modified on 2019/05/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase 2 study of safety and efficacy of a transanal tube (WING DRAIN) for the prevention of anastomotic leakage after rectal cancer surgery.
Acronym WING DRAIN Study
Scientific Title Phase 2 study of safety and efficacy of a transanal tube (WING DRAIN) for the prevention of anastomotic leakage after rectal cancer surgery.
Scientific Title:Acronym WING DRAIN Study
Region
Japan

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

Objectives
Narrative objectives1 WING DRAIN Study is a phase 2 trial to evaluate the safety and efficacy of a novel transanal tube:WING DRAIN for the prevention of anastomotic leakage after low anterior resection surgery for rectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Symptomatic leakage rate
Key secondary outcomes Symptomatic leakage rate and Radiological leakage rate
Complication rate connected with WING DRAIN

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 We placed transanal tube:WING DRAIN at low anterior resection surgery, and removed it at 4 or 5 postoperative days.
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. Rectal cancer is located at within 10cm above the anal verge
2. Histologically proven rectal adenocarcinoma on biopsy
3. Initial operation for rectal cancer excluding local excision
4. The patients undergoing low anterior resection with mechanical anastomosis
5. The patients have no ileus preoperatively.
6. Organ function is preserved
7. Patient with ECOG performance status of 0, 1, or 2
8. Written informed consent to participation in this trial
Key exclusion criteria 1. Emergency operation
2. Other conditions judged ineligible by physician
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Masaaki
Middle name
Last name Ito
Organization National Cancer Center Hospital East
Division name Colorectal Surgery
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa , Chiba , Japan 277-8577
TEL +81-4-7133-1111
Email maito@east.ncc.go.jp

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Nishizawa
Organization National Cancer Center Hospital East
Division name Colorectal Surgery
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa , Chiba , Japan 277-8577
TEL +81-4-7133-1111
Homepage URL
Email yunishiz@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Muranaka Medical Instruments.CO. LTD.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Cancer Center Hospital
Tokyo Metropolitan Cnncer and Infectious Diseases Center Komagome Hospital
Iwate Medical University School of Medicine
Kitasato University School of Medicine
Shizuoka Cancer Center
Name of secondary funder(s) Muranaka Medical Instruments.CO. LTD.

IRB Contact (For public release)
Organization National Cancer Center Hospital East
Address 6-5-1, Kashiwanoha, Kashiwa , Chiba , Japan 277-8577
Tel 04-7133-1111
Email yunishiz@east.ncc.go.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 07 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 06 Month 16 Day
Date of IRB
2017 Year 06 Month 27 Day
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2019 Year 01 Month 20 Day
Date of closure to data entry
2019 Year 02 Month 01 Day
Date trial data considered complete
2019 Year 02 Month 01 Day
Date analysis concluded
2019 Year 03 Month 12 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 23 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031452

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.