Unique ID issued by UMIN | UMIN000003303 |
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Receipt number | R000003993 |
Scientific Title | Randomized phase II study of clinical effect of ultrasonically activated coagulating shears (Harmonic scalpel) for open gastrectomy. |
Date of disclosure of the study information | 2010/03/09 |
Last modified on | 2012/03/09 20:59:48 |
Randomized phase II study of clinical effect of ultrasonically activated coagulating shears (Harmonic scalpel) for open gastrectomy.
Harmonic scalpel for open gastrectomy.
Randomized phase II study of clinical effect of ultrasonically activated coagulating shears (Harmonic scalpel) for open gastrectomy.
Harmonic scalpel for open gastrectomy.
Japan |
Gastric cancer
Gastrointestinal surgery |
Malignancy
NO
To investigate the clinical superiority of ultrasonically activated coagulating shears (Harmonic scalpel) for operative time from skin incision to resection of gastric specimen of open gastrectomy.
Efficacy
Exploratory
Pragmatic
Phase II
Operative time from skin incision to resection of gastric specimen
total operative time, operative blood loss, postoperative complications, postoperative hospital stay, medical costs.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Treatment
Device,equipment |
Open gastrectomy with ultrasonically activated coagulating shears
Open gastrectomy without ultrasonically activated coagulating shears
20 | years-old | <= |
90 | years-old | >= |
Male and Female
1)Primary treatment for histologically proven adenocarcinoma of the stomach.
2)Indication for open gastrectomy under Guidelines for Diagnosis and Treatment of Carcinoma of the Stomach(Edited by the Japanese Gasric Cancer Society).
3)Clinical stage IA to IIIB by preoperative examinations.
4)Age 20 to 90 years old.
5)Performance status (ECOG) 0 or 1.
6)Written informed consent.
1)Cancer of gastric remnant.
2)Intention of laparoscopic gastrectomy.
3)Prescribed antiplatelet and anticoagulant agent which needs alternative administration of heparin in the perioperative period.
4)Non curative factors proven by preoperative examinations.
5)Preoperative chemotherapy.
6)Synchronous malignancies other than carcinoma in situ of cervical cancer or focal cancer in adenoma of colorectal cancer.
7)Metachronous malignancies within 5 years or with tumor recurrence.
8)Severe respiratory dysfunction.
9)History of myocardinal infarction within 6 months before surgery.
10)Liver cirrhosis or active hepatitis.
11)Chronic renal failure with hemodialysis.
12)Uncontrolled diabetes mellitus (HbA1c 9.0 or more).
13)Other unfeasible factors to perform study safely approved by attending surgeon.
230
1st name | |
Middle name | |
Last name | Yuichiro Doki |
Graduate School of Medicine, Osaka University
Department of Gastroenterological Surgery
2-2-E2, Yamadaoka, Suita, Osaka, Japan
06-6879-3251
1st name | |
Middle name | |
Last name | Shuji Takiguchi |
Graduate School of Medicine, Osaka University
Department of Gastroenterological Surgery
2-2-E2, Yamadaoka, Suita, Osaka, Japan
06-6879-3251
stakiguchi@gesurg.med.osaka-u.ac.jp
Multicenter Clinical Study Group of Osaka (MCSGO)
none
Other
NO
2010 | Year | 03 | Month | 09 | Day |
Unpublished
Completed
2009 | Year | 12 | Month | 21 | Day |
2010 | Year | 03 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2010 | Year | 03 | Month | 09 | Day |
2012 | Year | 03 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003993
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