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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038241
Receipt No. R000043595
Scientific Title Prospective cohort study of acoustic analysis of postoperative bowel sounds
Date of disclosure of the study information 2019/10/09
Last modified on 2019/10/08

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Basic information
Public title Prospective cohort study of acoustic analysis of postoperative bowel sounds
Acronym Prospective cohort study of acoustic analysis of postoperative bowel sounds
Scientific Title Prospective cohort study of acoustic analysis of postoperative bowel sounds
Scientific Title:Acronym Prospective cohort study of acoustic analysis of postoperative bowel sounds
Region
Japan

Condition
Condition digestive disease
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Creating models that predict status of the bowel peristalsis by collecting abdominal sounds, extracting peristaltic sounds, and analyzing acoustically, then developing scientific diagnostic tools that can be used as an outcome in clinical practice and clinical trials.
Basic objectives2 Others
Basic objectives -Others Creating predictive models and diagnostic tools
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes status of the bowel peristalsis
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients over 20 years old scheduled for gastrointestinal surgery in our hospital
2. Patients who can obtain written consent
Key exclusion criteria 1. Patients who have difficulty obtaining consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Soshi
Middle name
Last name Hori
Organization Research Institute for Neuroscience, Southern Tohoku general hospital
Division name Department of surgery
Zip code 963-8052
Address 7-115 Yatsuyamada, Koriyama City, Fukushima Pref. Japan
TEL 024-934-5322
Email soshi0020@gmail.com

Public contact
Name of contact person
1st name Soshi
Middle name
Last name Hori
Organization Research Institute for Neuroscience, Southern Tohoku general hospital
Division name Department of surgery
Zip code 963-8052
Address 7-115 Yatsuyamada, Koriyama City, Fukushima Pref. Japan
TEL 024-934-5322
Homepage URL
Email soshi0020@gmail.com

Sponsor
Institute Research Institute for Neuroscience, Southern Tohoku general hospital
Institute
Department

Funding Source
Organization Research Institute for Neuroscience, Southern Tohoku general 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 Research Institute for Neuroscience, Southern Tohoku general hospital
Address 7-115 Yatsuyamada, Koriyama City, Fukushima Pref. Japan
Tel 024-934-5322
Email soshi0020@gmail.com

Secondary IDs
Secondary IDs YES
Study ID_1 357
Org. issuing International ID_1 Research Institute for Neuroscience, Southern Tohoku general hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 10 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
2019 Year 02 Month 08 Day
Date of IRB
2019 Year 04 Month 16 Day
Anticipated trial start date
2019 Year 02 Month 08 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 Development of a diagnostic model that analyzes abdominal sounds and objectively evaluates the state of intestinal peristalsis

Management information
Registered date
2019 Year 10 Month 08 Day
Last modified on
2019 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043595

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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