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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Rectal cancer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | 1. Emergency operation
2. Other conditions judged ineligible by physician |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
maito@east.ncc.go.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |