UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	comparison gastrointestinal function between circular and delta anastomosis post laparoscopy distal gastrectomy.
Title of the study (Brief title)	comparison gastrointestinal function between circular and delta anastomosis post laparoscopy distal gastrectomy.
Region	Japan

Condition
Condition	Gastric cancer patients after gastrectomy
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the gastrointestinal function of post gastrectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	questionnaire about postoperative quality of life
Key secondary outcomes	each examination of postoperative quality of life

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Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine Device,equipment
Interventions/Control_1	evaluate the gastrointestinal function of patients who underwent billtoth-1 recostruction after laparoscopy distal gastrectomy with delta anastomosis for gastric cancer.
Interventions/Control_2	evaluate the gastrointestinal function of patients who underwent billtoth-1 recostruction after laparoscopy distal gastrectomy with circular anastomosis for gastric cancer.
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. patient who underwent laparoscopy distal gastrectomy with Billoth-1 or circular anastomosis for early gastric cancer 2. curative resection and free from recurrence 3. for one year after treatment 4. Age>20 and <80 years 5. possible to intake orally 6. written informed consent
Key exclusion criteria	1. open procedure and total gastrectomy 2. except for laparoscopy distal gastrectomy with circular and delta anastomosis 3. with severe complication or active dual malignancy 4. judged as inappropriate by physician-in-charge
Target sample size	40

Research contact person
Name of lead principal investigator	Syuji Takiguchi
Organization	Osaka University School of Medicine
Division name	Gastroenterological Surgery
Address	2-2 Yamadaoka Suita City Osaka
TEL	06-6879-3251
Email	stakiguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Yoshitomo Yanagimoto
Organization	Osaka University School of Medicine
Division name	Gastroenterological Surgery
Address	2-2 Yamadaoka Suita City Osaka
TEL	06-6879-3251
Homepage URL
Email	yyanagimoto@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University School of Medicine Gastroenterological 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	none
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

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 30 Day
Anticipated trial start date	2013 Year 10 Month 02 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

Management information
Registered date	2013 Year 10 Month 01 Day
Last modified on	2016 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000013920