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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041307
Receipt No. R000047171
Scientific Title The Effect of Wearable Neuromuscular Electrical Stimulation in Major Abdominal Surgery: A Randomized Clinical Trial
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/04

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Basic information
Public title The Effect of Wearable Neuromuscular Electrical Stimulation in Major Abdominal Surgery: A Randomized Clinical Trial
Acronym The Effect of Wearable Neuromuscular Electrical Stimulation in Major Abdominal Surgery: A Randomized Clinical Trial
Scientific Title The Effect of Wearable Neuromuscular Electrical Stimulation in Major Abdominal Surgery: A Randomized Clinical Trial
Scientific Title:Acronym The Effect of Wearable Neuromuscular Electrical Stimulation in Major Abdominal Surgery: A Randomized Clinical Trial
Region
Japan

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

Objectives
Narrative objectives1 To assess the effect of wearable skeletal muscle electrical stimulation device on disuse muscle atrophy in postoperative patients with gastrointestinal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of change in quadriceps area
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Wearable Neuromuscular Electrical Stimulation
Interventions/Control_2 None
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with preoperative image diagnosis of gastric cancer or colon cancer
(2) Patients who have not undergone CT examination required for evaluation immediately before surgery (within 1 month in principle)
(3) Men or women who are 20 years of age or older when consent is obtained
(4) Patients who agreed in writing to participate in this study
Key exclusion criteria (1) Eastern Cooperative Oncology (ECOG) performance status (PS) 3 or higher
(2) Patients with neuromuscular disease
(3) Patients using electrical medical equipment such as pacemakers
(4) Patients who cannot use the skeletal muscle electrical stimulator due to metal inclusions
(5) Patients expected to require management in the intensive care unit for 2 days or more after surgery
(6) Patients who are pregnant or may be pregnant
(7) In addition, patients judged to be unsuitable for this study by the principal investigator or the doctor
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Yasuyuki
Middle name
Last name Fukami
Organization Aichi Medical University
Division name Department of Surgery
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Email yasuyuki490225@yahoo.co.jp

Public contact
Name of contact person
1st name Yasuyuki
Middle name
Last name Fukami
Organization Aichi Medical University
Division name Department of Surgery
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Homepage URL
Email yasuyuki490225@yahoo.co.jp

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization Aichi Medical University
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 Aichi Medical University
Address 1-1 Yazakokarimata, Nagakute, Aichi
Tel 0561-62-3311
Email yasuyuki490225@yahoo.co.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 09 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 28 Day
Date of IRB
2020 Year 07 Month 28 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2022 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 08 Month 04 Day
Last modified on
2020 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047171

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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