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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022218
Receipt No. R000025239
Scientific Title A randomized controlled trial of single-incision versus conventional multi-port laparoscopic gastrectomy for clinical stage I gastric cancer
Date of disclosure of the study information 2016/05/09
Last modified on 2019/08/27

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Basic information
Public title A randomized controlled trial of single-incision versus conventional multi-port laparoscopic gastrectomy for clinical stage I gastric cancer
Acronym A randomized trial of SLG vs. MLG for clinical stage I gastric cancer
Scientific Title A randomized controlled trial of single-incision versus conventional multi-port laparoscopic gastrectomy for clinical stage I gastric cancer
Scientific Title:Acronym A randomized trial of SLG vs. MLG for clinical stage I gastric cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety and efficacy of single-incision laparoscopic gastrectomy compared to conventional multi-port laparoscopic gastrectomy for clinical stage I gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Degree of postoperative pain
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Single-incision laparoscopic gastrectomy
Interventions/Control_2 Multi-port laparoscopic gastrectomy
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) Histologically confirmed gastric adenocarcinoma.
(2) Indication of distal gastrectomy.
(3) c Stage I gastric cancer.
(4) No invasion to the duodenum
(5) Body mass index <30.
(6) Written informed consent.
Key exclusion criteria (1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ.
(2) Women during pregnancy or breast-feeding.
(3) Severe mental disease.
(4) Continuous systemic steroid therapy.
(5) History of myocardial infarction or unstable angina pectoris within six months.
(6) Uncontrollable hypertension.
(7) Uncontrollable diabetes millutus.
(8) Severe respiratory disease requiring continuous oxygen therapy.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Omori
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastroenterological Surgery
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka, Japan
TEL +81669721181
Email oomori-ta@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Omori
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastroenterological Surgery
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka, Japan
TEL +81669721181
Homepage URL
Email oomori-ta@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization Other
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 大阪府立成人病センター 

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 09 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 Enrolling by invitation
Date of protocol fixation
2015 Year 09 Month 30 Day
Date of IRB
2016 Year 02 Month 17 Day
Anticipated trial start date
2016 Year 05 Month 09 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 05 Month 06 Day
Last modified on
2019 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025239

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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