Unique ID issued by UMIN | UMIN000021131 |
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Receipt number | R000024380 |
Scientific Title | Evaluation of postoperative quality of life after Billroth-I distal gastrectomy and pylorus-preserving gastrectomy for Stage I gastric cancer |
Date of disclosure of the study information | 2016/03/01 |
Last modified on | 2016/02/22 08:53:24 |
Evaluation of postoperative quality of life after Billroth-I distal gastrectomy and pylorus-preserving gastrectomy for Stage I gastric cancer
Evaluation of postoperative quality of life after Billroth-I distal gastrectomy and pylorus-preserving gastrectomy for Stage I gastric cancer
Evaluation of postoperative quality of life after Billroth-I distal gastrectomy and pylorus-preserving gastrectomy for Stage I gastric cancer
Evaluation of postoperative quality of life after Billroth-I distal gastrectomy and pylorus-preserving gastrectomy for Stage I gastric cancer
Japan |
gastric cancer
Gastrointestinal surgery |
Malignancy
NO
To demonstrate the superiority of pylorus-preserving gastrectomy over distal gastrectomy in postoperative dumping syndrome incidence.
Safety
To demonstrate the superiority of pylorus-preserving gastrectomy over distal gastrectomy in postoperative dumping syndrome incidence.
quality of life (PGSAS37ï½¥EORTC), operative time, intraoperative blood loss, morbidity, mortality, short-term mortality
Observational
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) pathologically-confirmed gastric cancer (papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma, signet ring cell carcinoma and mucinous adenocarcinoma)
2) cStage IA or IB, but not T2 tumor at the greater curvature of the stomach
3) No indication of endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) in a cN0 or cN1case
4) Patients who underwent EMR or ESD and need additional surgery
5) Aged 20 to 80 year
6) PS (ECOG) 0 or 1
7) No history of gastrointestinal surgery
8) No history of chemotherapy or radiotherapy
9) Capability of filling out a survey independently
10) Provided written informed consent
1) Synchronous or metachronous malignancies other than carcinoma in situ
2) Simultaneous surgery other than cholecystectomy
3) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
128
1st name | |
Middle name | |
Last name | Yasuhiro Kodera |
Nagoya University Graduate School of Medicine
Department of Gastroenterological Surgery
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
052-744-2111
ykodera@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Chie Tanaka |
Nagoya University Graduate School of Medicine
Department of Gastroenterological Surgery
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
052-744-2250
chtanaka@med.nagoya-u.ac.jp
Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
None
Self funding
NO
2016 | Year | 03 | Month | 01 | Day |
Unpublished
Open public recruiting
2016 | Year | 01 | Month | 27 | Day |
2016 | Year | 02 | Month | 01 | Day |
Preoperative assessment;
1) Physical examinations
2) Blood test
3) Imaging
4) Electrocardiogram
5) Respiratory function test
6) Questionnaires of the QOL (EORTC QLQ-C30, PGSAS37)
Intra- and postoperative assessment;
1) Intraoperative findings
2) Pathological findings
3) Postoperative complications
4) Blood test
5) Imaging
6) Measurement of body weight
7) Questionnaires of the QOL (EORTC QLQ-C30, PGSAS37)
8) date of recurrence and death
2016 | Year | 02 | Month | 22 | Day |
2016 | Year | 02 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024380
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