Unique ID issued by UMIN | UMIN000014068 |
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Receipt number | R000016216 |
Scientific Title | Randomized clinical trial of an enhanced recovery after surgery protocol in patients undergoing pancreaticoduodenectomy |
Date of disclosure of the study information | 2014/05/26 |
Last modified on | 2016/11/18 11:08:53 |
Randomized clinical trial of an enhanced recovery after surgery protocol in patients undergoing pancreaticoduodenectomy
Randomized clinical trial of an enhanced recovery after surgery protocol in patients undergoing pancreaticoduodenectomy
Randomized clinical trial of an enhanced recovery after surgery protocol in patients undergoing pancreaticoduodenectomy
Randomized clinical trial of an enhanced recovery after surgery protocol in patients undergoing pancreaticoduodenectomy
Japan |
Patients to require pancreaticoduodenectomy
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To investigate the efficiency of an enhanced recovery after surgery(ERAS) protocol in patients undergoing pancreaticoduodenectomy(PD)
Efficacy
Confirmatory
Pragmatic
Not applicable
median length of postoperative hospital stay
(1)postoperative morbidity/mortality
(2)immune and metabolism response
(3)Compliance with components of the enhanced recovery after surgery (ERAS) protocol
(4)mean medical cost
(5)Safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
NO
Central registration
2
Treatment
Other |
ERAS group which receive ERAS protocols
control group which receive standard cares
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Patients to require pancreaticoduodenectomy
(1)failure to obtain consent
(2)severe respiratory dysfunction (arterial PaO2 < 70 mmHg)
(3)severe cardiac dysfunction (NYHA > 2)
(4)severe hepatic dysfunction (Child Pugh class C)
(5)severe renal dysfunction (hemodialysis)
(6)pregnancy
(7)preoperative chemotherapy and/or radiation therapy
(8)acute bacterial or viral infections
(9)severe psychiatric disorder
(10)immunocompromised status
(11)advanced malignancy
(12)palliative surgery
(13)emergency surgery
(14)investigator not available
80
1st name | |
Middle name | |
Last name | Ryuichi Yoshida |
Okayama University Hospital
Department of Hepato-biliary-pancreatic Surgery
2-5-1, Shikata cho, Kita ku, Okayama city
086-235-7257
ryuichi-yoshida@md.okayama-u.ac.jp
1st name | |
Middle name | |
Last name | Kosei Takagi |
Okayama University Hospital
Department of Hepato-biliary-pancreatic Surgery
2-5-1, Shikata cho, Kita ku, Okayama city
086-235-7257
kosei0913@hotmail.co.jp
Okayama University Graduate School of Medicine and Dentistry, Department of Gastroenterological Surgery
Okayama University Graduate School of Medicine and Dentistry, Department of Gastroenterological Surgery
Self funding
NO
2014 | Year | 05 | Month | 26 | Day |
Unpublished
Completed
2014 | Year | 05 | Month | 20 | Day |
2014 | Year | 05 | Month | 26 | Day |
2014 | Year | 05 | Month | 26 | Day |
2016 | Year | 11 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016216
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