UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018808 |
|---|---|
| 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 | 2024/09/01 09:12:05 |
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Basic information
Public title
Assessment of postoperative quality of life in patients with stage I gastric cancer; a comparative study between open and laparoscopic gastrectomy
Acronym
Assessment of postoperative quality of life in patients with stage I gastric cancer; a comparative study between open and laparoscopic gastrectomy
Scientific Title
Assessment of postoperative quality of life in patients with stage I gastric cancer; a comparative study between open and laparoscopic gastrectomy
Scientific Title:Acronym
Assessment of postoperative quality of life in patients with stage I gastric cancer; a comparative study between open and laparoscopic gastrectomy
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare postoperative quality of life between open and laparoscopic total gastrectomy in patients with stage I gastric cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To demonstrate the superiority of laparoscopic total gastrectomy over open total gastrectomy in postoperative quality of life
Key secondary outcomes
operative time, intraoperative blood loss, morbidity, mortality, short-term mortality
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2111
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Tanaka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2111
Homepage URL
chtanaka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee
Address
65 Tsurumai-cho,Showa-ku,Nagoya
Tel
052-744-2479
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
84
Results
Finally 43 patients for the laparoscopic group and 16 for the open group were eligible for data analysis. There were no significant differences in body weight change between the two groups. The role functioning score among the EORTC QLQ-C30 tended to be higher in the laparoscopic group at POM 1 and 12 after surgery compared to the open group. The dissatisfaction at working score among the PGSAS-37 at 1 month after surgery was lower in the laparoscopic group compared to the open group.
Results date posted
| 2024 | Year | 09 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 04 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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)
Management information
Registered date
| 2015 | Year | 08 | Month | 26 | Day |
Last modified on
| 2024 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019449
