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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031713
Receipt No. R000036200
Scientific Title Benefit of coughing pain relief and pulmonary restoration by bilateral abdominal compression maneuver.
Date of disclosure of the study information 2018/03/20
Last modified on 2018/03/14

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Basic information
Public title Benefit of coughing pain relief and pulmonary restoration by bilateral abdominal compression maneuver.
Acronym Benefit of coughing pain relief and pulmonary restoration by bilateral abdominal compression maneuver.
Scientific Title Benefit of coughing pain relief and pulmonary restoration by bilateral abdominal compression maneuver.
Scientific Title:Acronym Benefit of coughing pain relief and pulmonary restoration by bilateral abdominal compression maneuver.
Region
Japan

Condition
Condition Gastrointestinal disease
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We devised bilateral abdominal compression maneuver. It is a procedure of squeezing both side flanks from the left and right as to pinch the incision, and compressing them. We aim to investigate whether this maneuver on coughing relive incision pain or restore pulmonary dysfunction postoperatively or not.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome is postoperative pain on coughing and restoration of respiratory function on POD1, 3, 5and7. Pain score is measured by using Prince Henry pain scale and visual analog scale. Among respiratory functions, vital capacity and peak cough flow are measured by portable spirometer.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 For evaluation of coughing pain, we use Prince Henry pain scale and Visual analogue scale before lunch on POD1, 3, 5, 7, and evaluate pain two times when using bilateral abdominal compression maneuver and when not using at random. For evaluation of respiratory function, we use spirometer to measure vital capacity and peak cough flow: PCF. We examine the day before the operation and POD1, 3, 5, 7 before lunch, the measuring position should be sitting, if impossible, the lying position, the measurement will be started after two minutes of posture maintenance. The order of measurement is VC and PCF with bilateral abdominal compressions, VC and PCF without bilateral abdominal compression at random, and rest between each measurement is two minutes.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who undergo gastroenterological operation at Department of Surgery, Kyorin University School of Medicine.
Key exclusion criteria The patients who undergo emergency operation, the patients difficult to take a mutual understanding such as dementia, psychotic and under sedated patients, the patients unable to squeeze their flank by themselves such as restrained patients, the patients unable to assess pain such as dementia and psychotic patients, and the patients refusal to participate
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hayato Shimoyama
Organization Kyorin University School of Medicine
Division name Department of Surgery
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo
TEL +81-422-47-5511
Email hayatos@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hayato Shimoyama
Organization Kyorin University School of Medicine
Division name Department of Surgery
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo
TEL +81-422-47-5511
Homepage URL
Email hayatos@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University School of Medicin
Institute
Department

Funding Source
Organization None
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
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 杏林大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 20 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 12 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 14 Day
Last modified on
2018 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036200

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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