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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023770
Receipt No. R000025815
Scientific Title Study of the relief of pain on coughing after surgery by bilateral flank compression maneuver.
Date of disclosure of the study information 2016/08/25
Last modified on 2018/12/19

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Basic information
Public title Study of the relief of pain on coughing after surgery by bilateral flank compression maneuver.
Acronym bilateral flank compression maneuver
Scientific Title Study of the relief of pain on coughing after surgery by bilateral flank compression maneuver.
Scientific Title:Acronym bilateral flank 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 have devised a bilateral flank compression procedure. bilateral flank compression procedure means that the pressure on flank against his hands on both sides flank of the patient. bilateral flank compression procedure is to consider whether or not to reduce the pain at the time of sputum discharge after surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We investigate whether compression maneuver relieve coughing pain or not on each day through postoperative seven days.
Key secondary outcomes The relationship between patients and operation factors (age, sex, comorbidity, disease, location, timing, operation time, approach, length, number and type of incision, intraoperative drain, anesthesia, and postoperative analgesia) and compression maneuver.

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 NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Once a day from POD1 up to a maximum of POD7, any nurses who had learned this maneuver in a surgical ward or intensive care unit, recorded daily pain score on coughing twice when using this maneuver and not, at random around 10 a.m.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent abdominal surgery at Department of Surgery, Kyorin University School of Medicine.Patients consent from the person has been obtained before the study registration in writing
Key exclusion criteria Patient difficult to take a mutual understanding such as sedative use patients and psychiatric patients.Patients who can not squeeze the abdomen such as a patient in the trunk suppression.Patients who can not assess the pain such as dementia patientsand psychiatric patients.Patients who refused to participate in the study.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Sugiyama
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 sgym@ks.krorin-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 su88aman@hotmail.com

Sponsor
Institute Kyorin University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization none

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
2016 Year 08 Month 25 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
2016 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 29 Day
Last follow-up date
Date of closure to data entry
2017 Year 10 Month 01 Day
Date trial data considered complete
2018 Year 01 Month 20 Day
Date analysis concluded
2018 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 25 Day
Last modified on
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025815

Research Plan
Registered date File name
2018/12/19 2018.下山 研究計画書(プロトコール).doc

Research case data specifications
Registered date File name
2018/12/19 両側側腹部圧迫法 CRF.docx

Research case data
Registered date File name
2018/12/19 提出用.xlsx


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