UMIN-CTR Clinical Trial

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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