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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011923
Receipt No. R000013920
Scientific Title comparison gastrointestinal function between circular and delta anastomosis post laparoscopy distal gastrectomy.
Date of disclosure of the study information 2013/10/01
Last modified on 2016/04/01

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Basic information
Public title comparison gastrointestinal function between circular and delta anastomosis post laparoscopy distal gastrectomy.
Acronym comparison gastrointestinal function between circular and delta anastomosis post laparoscopy distal gastrectomy.
Scientific Title comparison gastrointestinal function between circular and delta anastomosis post laparoscopy distal gastrectomy.
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Syuji Takiguchi
Organization Osaka University School of Medicine
Division name Gastroenterological Surgery
Zip code
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
1st name
Middle name
Last name Yoshitomo Yanagimoto
Organization Osaka University School of Medicine
Division name Gastroenterological Surgery
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 08 Month 30 Day
Date of IRB
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

Other
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-open-bin/ctr_e/ctr_view.cgi?recptno=R000013920

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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