Unique ID issued by UMIN | UMIN000000960 |
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Receipt number | R000001154 |
Scientific Title | Randomized Clinical Trial of Roux-en-Y versus rho-Roux-en-Y Reconstruction after Distal Gastrectomy for Gastric Cancer |
Date of disclosure of the study information | 2008/01/11 |
Last modified on | 2007/12/28 16:39:06 |
Randomized Clinical Trial of Roux-en-Y versus rho-Roux-en-Y Reconstruction after Distal Gastrectomy for Gastric Cancer
rho R-Y study
Randomized Clinical Trial of Roux-en-Y versus rho-Roux-en-Y Reconstruction after Distal Gastrectomy for Gastric Cancer
rho R-Y study
Japan |
Distal Gastrectomy for Gastric Cancer
Gastrointestinal surgery |
Malignancy
NO
To determine the frequency of the DGE, prospectively in patients who had undergone distal gastrectomy for gastric malignant disease, in comparison with RY and rRY reconstructions.
Efficacy
Confirmatory
Phase III
To determine the frequency of DGE (delayed gastric emptying)
The length of post-operative stay, post-operative complications, and some nutritional status after operation.
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
YES
2
Treatment
Maneuver |
rho-RY reconstruction (rRY)
standard RY reconstruction
20 | years-old | <= |
90 | years-old | >= |
Male and Female
Patients, who needed the distal gastrectomy for gastric cancer with reconstruction except of BI, were eligible for this study. Other eligibility criteria were: age between 20 and 90 years; Eastern Cooperative Oncology Group (ECOG) performance status of 1 or 0; RY reconstruction after resection was necessary; acceptable renal and hepatic function, and normal ECG.
Patients were excluded if they had active infection, severe heart disease, pregnancy, active synchronous carcinoma, interstitial pneumonia or pulmonary fibrosis, carcinoma in the remnant stomach, Borrmann type 4 (linitis plastica), non-curative factors, such as peritoneal dissemination, hepatic metastasis, and severe invasion to other organs by the pre-operative diagnosis, an anamnesis of laparotomy for upper gastrointestinal diseases. Written informed consent was obtained from all patients.
70
1st name | |
Middle name | |
Last name | Motohiro Hirao |
Osaka national hospital
surgery
2-1-14 Hoenzaka, Osaka city, Japan
1st name | |
Middle name | |
Last name | Motohiro Hirao |
Osaka national hospital
surgery
hiraom@onh.go.jp
Osaka national hospital
Osaka national hospital
NO
2008 | Year | 01 | Month | 11 | Day |
Partially published
Completed
2004 | Year | 03 | Month | 10 | Day |
2004 | Year | 05 | Month | 01 | Day |
2007 | Year | 11 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2008 | Year | 02 | Month | 01 | Day |
2007 | Year | 12 | Month | 28 | Day |
2007 | Year | 12 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001154
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