Unique ID issued by UMIN | UMIN000010530 |
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Receipt number | R000012313 |
Scientific Title | Evaluation on usefulness and safety of cysto-urethral anastomosis with additional ileal flap in patients with rectal cancer involving the prostate |
Date of disclosure of the study information | 2013/05/01 |
Last modified on | 2019/05/31 15:44:40 |
Evaluation on usefulness and safety of cysto-urethral anastomosis with additional ileal flap in patients with rectal cancer involving the prostate
Ileal flap study
Evaluation on usefulness and safety of cysto-urethral anastomosis with additional ileal flap in patients with rectal cancer involving the prostate
Ileal flap study
Japan |
Lower rectal cancer involving the prostate
Gastrointestinal surgery | Urology |
Malignancy
NO
Improvement and prevention of cysto-urethral anastomotic leakage.
Safety of additional flap operation.
Safety,Efficacy
Confirmatory
Cysto-urethral anastomotic leak rate at postoperative one month.
Rate of major leakage in cysto-urethral anastomosis.
Healing term of CUA leakage.
Safety of flap operation.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Additional ileal flap operation in cysto-urethral anastomosis.
20 | years-old | <= |
75 | years-old | >= |
Male
1.Male patients with locally advanced rectal cancer involving the prostate clinically.
2.Pathological proven adenocarcinoma.
3.Possible to be preservation of the sphincter urethrae.
4.With or Without anus-preservation.
5.No distant metastasis.
6.Normal length of the small intestine.
7.Aged 20 to 75 years old.
8.PS(ECOG) of 0 or 1.
9.Enough organ functions.
WBC count : >=3000/mm3
Platelet count : >=70000/mm3
Hemoglobin : >=8.0g/dl
T-Bil : <=1.5mg/dl
AST : <=100IU/l
ALT : <=100IU/l
Cr : <=1.5mg/dl
Alb : >=2.8g/dl
10. With or Without previous radiotherapy and chemotherapy.
11. Writhen informed consent.
1. Patients with request of total pelvic exenteration (TPE), or patients without request of the ileal flap operation.
2. Impossible to be curative resection.
3. Patients with serious disease as follows.
Uncontrollable diabetes mellitus(Hba1c >=8%)
renal failure requiring artificial dialysis.
requiring immunosuppressants
4. Patients with serious organ failure.
5. Cannot agree on this study.
6. Unsuitable patients for this study.
12
1st name | |
Middle name | |
Last name | Norio Saito |
National Cancer Center Hospital East
Colorectal and Pelvic Surgery
6-5-1, Kashwanoha, Kashiwa, 277-8577, Japan
04-7133-1111
norsaito@east.ncc.go.jp
1st name | |
Middle name | |
Last name | Norio Saito |
National Cancer Center Hospital East
Colorectal and Pelvic Surgery
6-5-1, Kashwanoha, Kashiwa, 277-8577, Japan
04-7133-1111
norsaito@east.ncc.go.jp
National Cancer Center Hospital East
Ministry of Health, Labour and Welfare
Japanese Governmental office
Japan
NO
国立がん研究センター東病院(千葉県)
愛知県がんセンター中央病院(愛知県)
2013 | Year | 05 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 03 | Month | 13 | Day |
2013 | Year | 03 | Month | 04 | Day |
2013 | Year | 04 | Month | 01 | Day |
2014 | Year | 09 | Month | 17 | Day |
2013 | Year | 04 | Month | 18 | Day |
2019 | Year | 05 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012313
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