UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041307 |
|---|---|
| Receipt number | 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 | 2023/01/04 14:30:24 |
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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
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
yasuyuki490225@yahoo.co.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
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
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
Open public recruiting
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
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047171
