UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029007 |
|---|---|
| Receipt number | R000033189 |
| Scientific Title | Analysis of intestinal peristalsis during perioperative period using bowel sound for monitoring of patients who undergo operation under general anesthesia |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2022/07/09 08:47:23 |
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Basic information
Public title
Analysis of intestinal peristalsis during perioperative period using bowel sound for monitoring of patients who undergo operation under general anesthesia
Acronym
Analysis of intestinal peristalsis using bowel sound monitoring system
Scientific Title
Analysis of intestinal peristalsis during perioperative period using bowel sound for monitoring of patients who undergo operation under general anesthesia
Scientific Title:Acronym
Analysis of intestinal peristalsis using bowel sound monitoring system
Region
| Japan |
Condition
Condition
Diseases of gastrointestinal, hepatobilliary or endocrinical system
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of bowel sound monitoring system during perioperative period for the patients who undergo surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of bowel sound before and after operation
Key secondary outcomes
1. Correlation of bowel sound and blood glycemic changes
2. Differentiation of bowel sound between alimentary tract surgery and breast surgery
3. Differentiation of bowel soudn between laparoscopic surgery and open surgery
4. Differentiation of bowel sound depending on enteral nutrition
5. Differentiation of bowel sound depending on general anesthesia
6. DIfferentiation of bowel sound before and after Pringle procedure for hepatic surgery
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who undergo gastrointestinal, hepatobilliary, breast or thyroid surgery.
2. A performance status of 0-2 according to the Eastern Cooperative Oncology Group (ECOG) scale.
3. An age of 20 years and over.
4. Patients who are considered to survive for more than 3 months from the registration.
5. Vital organ function are preserved within 14 days prior to entry.
6. Sufficient oral intake.
7. All patients gave written informed consent.
Key exclusion criteria
1. Serious cardiovascular diseases.
2. Serious conccurent disease suc as intestinal palsy, small bowel obstruction, uncontrolable diabetes mellitus, renal failure, liver cirrhosis, and so on.
3. Massive ascites beyound the pelvic cavity or pleural effusion.
4. Women who are pregnant or hope to become pregnant during the study period. Men who wish their partner to become pregnant.
5. Patients judged inappropriate for the study by their physicians.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Namikawa |
Organization
Kochi Medical School
Division name
Department of Surgery
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL
+81-88-880-2370
tsutomun@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Namikawa |
Organization
Kochi Medical School
Division name
Department of Surgery
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL
+81-88-880-2370
Homepage URL
http://www.kochi-ms.ac.jp/~fm_srgr1/index.html
tsutomun@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Kochi Medical School
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We assess the association between the bowel sound using this novel monitoring system and clinical data during perioperative period for the patients who undergo surgery.
Management information
Registered date
| 2017 | Year | 09 | Month | 05 | Day |
Last modified on
| 2022 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033189
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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