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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041824
Receipt No. R000047740
Scientific Title Safety and efficacy of preoperative short-term weight loss with formula diet in patients with BMI> 30 in endoscopic surgery
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/17

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Basic information
Public title Safety and efficacy of preoperative short-term weight loss with formula diet in patients with BMI> 30 in endoscopic surgery
Acronym Safety and efficacy of preoperative short-term weight loss with formula diet in patients with BMI> 30 in endoscopic surgery
Scientific Title Safety and efficacy of preoperative short-term weight loss with formula diet in patients with BMI> 30 in endoscopic surgery
Scientific Title:Acronym Safety and efficacy of preoperative short-term weight loss with formula diet in patients with BMI> 30 in endoscopic surgery
Region
Japan

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

Objectives
Narrative objectives1 Incidence of postoperative pulmonary complications
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Incidence of postoperative pulmonary complications
Key secondary outcomes Visceral fat loss rate, surgical time, intraoperative blood loss, incidence of anastomotic insufficiency, number of lymph node dissections

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 For one month before surgery, one of the three meals should be a formula meal (170 kcal or 340 kcal), and the other two meals should be a normal meal (600 kcal each)
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 BMI>30kg/m2
Key exclusion criteria Total protein<6.5, Albumin<4.1,Active cardiac complications, Active pulmonary complications, PS>1
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kiyotomi
Middle name
Last name Maruyama
Organization Suwa Red Cross Hospital
Division name Department o surgery
Zip code 392-0022
Address 5-11-50, Kogandoori, Suwa, Nagano
TEL 0266526111
Email kiyomaru@suwa.jrc.or.jp

Public contact
Name of contact person
1st name Kiyotomi
Middle name
Last name Maruyama
Organization Suwa Red Cross Hospital
Division name Department of surgery
Zip code 392-0027
Address 5-11-50, Kogandoori, Suwa, Nagano
TEL 0266526111
Homepage URL
Email kiyomaru@suwa.jrc.or.jp

Sponsor
Institute Suwa Red Cross Hospital
Department of surgery
Institute
Department

Funding Source
Organization Suwa Red Cross Hospital
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 Suwa Red Cross Hospital
Address 5-11-50, Kogandoori, Suwa, Nagano
Tel 0266526111
Email kiyomaru@suwa.jrc.or.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
2020 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 Open public recruiting
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
2020 Year 02 Month 17 Day
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2025 Year 12 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
2020 Year 09 Month 17 Day
Last modified on
2020 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047740

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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