UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment for the postgastrectomy syndrome
Title of the study (Brief title)	Assessment for the postgastrectomy syndrome
Region	Japan

Condition
Condition	Gastric cancer without distant metastasis
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate general and nutritional condition for the postgastrectomy patients.
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Post operative Quality of Life. ( One month after, One year after)
Key secondary outcomes	Post operative nutritional condition. ( One month after, One year after)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Histologically proven primary gastric cancer without distant metastasis
Key exclusion criteria	Metastasis to distant organ sites, other active concomitant malignancies, or recurrent gastric cancers.
Target sample size	200

Research contact person
Name of lead principal investigator	Shigeru Sasaki
Organization	Saitama Red Cross Hospital
Division name	Department of Surgery
Address	8-3-33, Kamiochiai, Chuo-ku, Saitama city, Saitama
TEL	048-645-1617
Email	shsasaki@saitama-med.jrc.or.jp

Public contact
Name of contact person	Shigeru Sasaki
Organization	Saitama Red Cross Hospital
Division name	Department of Surgery
Address	8-3-33, Kamiochiai, Chuo-ku, Saitama city, Saitama
TEL	048-645-1617
Homepage URL
Email	shsasaki@saitama-med.jrc.or.jp

Sponsor
Institute	Saitama Red Cross Hospital, Department of Surgery
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Saitama Red Cross Hospital, Department of Surgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	さいたま赤十字病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 20 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 08 Month 01 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Clinical stage of gastric cancer, Type of pathological character, Ages, Comorbidity, With or without chemotherapy, Type of operation and reconstruction, Operation time, Complications, PGSAS-45(PGSAS-37 + SF-8), Body Composition Analyze, etc.

Management information
Registered date	2016 Year 04 Month 19 Day
Last modified on	2016 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025342