Unique ID issued by UMIN | UMIN000027455 |
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Receipt number | 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 11:12:20 |
Phase 2 study of safety and efficacy of a transanal tube (WING DRAIN) for the prevention of anastomotic leakage after rectal cancer surgery.
WING DRAIN Study
Phase 2 study of safety and efficacy of a transanal tube (WING DRAIN) for the prevention of anastomotic leakage after rectal cancer surgery.
WING DRAIN Study
Japan |
Rectal cancer
Gastrointestinal surgery |
Malignancy
NO
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.
Safety,Efficacy
Confirmatory
Phase II
Symptomatic leakage rate
Symptomatic leakage rate and Radiological leakage rate
Complication rate connected with WING DRAIN
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
Central registration
1
Treatment
Device,equipment |
We placed transanal tube:WING DRAIN at low anterior resection surgery, and removed it at 4 or 5 postoperative days.
20 | years-old | <= |
Not applicable |
Male and Female
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
1. Emergency operation
2. Other conditions judged ineligible by physician
120
1st name | Masaaki |
Middle name | |
Last name | Ito |
National Cancer Center Hospital East
Colorectal Surgery
277-8577
6-5-1, Kashiwanoha, Kashiwa , Chiba , Japan 277-8577
+81-4-7133-1111
maito@east.ncc.go.jp
1st name | Yuji |
Middle name | |
Last name | Nishizawa |
National Cancer Center Hospital East
Colorectal Surgery
277-8577
6-5-1, Kashiwanoha, Kashiwa , Chiba , Japan 277-8577
+81-4-7133-1111
yunishiz@east.ncc.go.jp
National Cancer Center Hospital East
Muranaka Medical Instruments.CO. LTD.
Self funding
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
Muranaka Medical Instruments.CO. LTD.
National Cancer Center Hospital East
6-5-1, Kashiwanoha, Kashiwa , Chiba , Japan 277-8577
04-7133-1111
yunishiz@east.ncc.go.jp
NO
2017 | Year | 07 | Month | 01 | Day |
Unpublished
No longer recruiting
2017 | Year | 06 | Month | 16 | Day |
2017 | Year | 06 | Month | 27 | Day |
2017 | Year | 08 | Month | 01 | Day |
2019 | Year | 01 | Month | 20 | Day |
2019 | Year | 02 | Month | 01 | Day |
2019 | Year | 02 | Month | 01 | Day |
2019 | Year | 03 | Month | 12 | Day |
2017 | Year | 05 | Month | 23 | Day |
2019 | Year | 05 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031452
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