UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023770 |
|---|---|
| Receipt number | 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 01:22:34 |
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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
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
su88aman@hotmail.com
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/25815
