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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029007
Receipt No. 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 2018/11/16

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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
Email 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
Email tsutomun@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
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
2018 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033189

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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