Unique ID issued by UMIN | UMIN000018808 |
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Receipt number | R000019449 |
Scientific Title | Assessment of postoperative quality of life in patients with stage I gastric cancer; a comparative study between open and laparoscopic gastrectomy |
Date of disclosure of the study information | 2015/08/26 |
Last modified on | 2019/08/29 15:34:24 |
Assessment of postoperative quality of life in patients with stage I gastric cancer; a comparative study between open and laparoscopic gastrectomy
Assessment of postoperative quality of life in patients with stage I gastric cancer; a comparative study between open and laparoscopic gastrectomy
Assessment of postoperative quality of life in patients with stage I gastric cancer; a comparative study between open and laparoscopic gastrectomy
Assessment of postoperative quality of life in patients with stage I gastric cancer; a comparative study between open and laparoscopic gastrectomy
Japan |
gastric cancer
Gastrointestinal surgery |
Malignancy
NO
To compare postoperative quality of life between open and laparoscopic total gastrectomy in patients with stage I gastric cancer.
Safety
To demonstrate the superiority of laparoscopic total gastrectomy over open total gastrectomy in postoperative quality of life
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) No invasion of the esophagus
6) Aged 20 to 80 year
7) PS (ECOG) 0 or 1
8) No history of gastrointestinal surgery
9) No history of chemotherapy or radiotherapy
10) Capability of filling out a survey independently
11) Provided written informed consent
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
2) Simultaneous surgery other than cholecystectomy
3) Body mass index 30 or more
4) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
140
1st name | Yasuhiro |
Middle name | |
Last name | Kodera |
Nagoya University Graduate School of Medicine
Department of Gastroenterological Surgery
4668550
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
052-744-2111
ykodera@med.nagoya-u.ac.jp
1st name | Chie |
Middle name | |
Last name | Tanaka |
Nagoya University Graduate School of Medicine
Department of Gastroenterological Surgery
4668550
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
052-744-2111
chtanaka@med.nagoya-u.ac.jp
Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Self funding
Self funding
Ethics Review Committee
65 Tsurumai-cho,Showa-ku,Nagoya
052-744-2479
ethics@med.nagoya-u.ac.jp
NO
2015 | Year | 08 | Month | 26 | Day |
Unpublished
Open public recruiting
2015 | Year | 06 | Month | 15 | Day |
2015 | Year | 07 | Month | 24 | Day |
2015 | Year | 08 | Month | 01 | Day |
2023 | Year | 12 | Month | 31 | 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)
2015 | Year | 08 | Month | 26 | Day |
2019 | Year | 08 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019449
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