UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031713
Receipt number R000036200
Scientific Title Postoperative benefit of coughing pain relief and pulmonary restoration by bilateral flank compression maneuver.
Date of disclosure of the study information 2018/03/20
Last modified on 2023/10/03 09:12:42

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Basic information

Public title

Postoperative benefit of coughing pain relief and pulmonary restoration by bilateral flank compression maneuver.

Acronym

Postoperative benefit of coughing pain relief and pulmonary restoration by bilateral flank compression maneuver.

Scientific Title

Postoperative benefit of coughing pain relief and pulmonary restoration by bilateral flank compression maneuver.

Scientific Title:Acronym

Postoperative benefit of coughing pain relief and pulmonary restoration by 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 devised the bilateral flank 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 numerical rating scale. Among respiratory functions, vital capacity and peak cough flow are measured by a spirometer or a peak flow meter.

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 numerical rating scale before lunch on POD1, 3, 5, 7, and evaluate pain two times when using bilateral flank compression maneuver and when not using at random. For evaluation of respiratory function, we use a spirometer to measure vital capacity and a peak flow meter to measure peak cough flow: PCF. We examine the day before the operation and POD1, 3, 5, 7 before lunch, the measuring position should be sitting, the measurement will be started after two minutes of posture maintenance. The order of measurement is VC and PCF with bilateral flank compressions, VC and PCF without bilateral flank 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who undergo gastroenterological operation at Department of Surgery, Kyorin University School of Medicine, or Department of Gastroenterological Surgery, Toranomon Hospital.

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 perform respiratory function test (Patients who cannot perform respiratory function tests (patients who cannot walk or maintain posture), 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 Shimoyama
Middle name
Last name Hayato

Organization

Kyorin University School of Medicine

Division name

Department of Surgery

Zip code

181-8611

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 Shimoyama
Middle name
Last name Hayato

Organization

Kyorin University School of Medicine

Division name

Department of Surgery

Zip code

181-8611

Address

6-20-2 Shinkawa, Mitaka, Tokyo

TEL

+81-422-47-5511

Homepage URL


Email

hayatos@ks.kyorin-u.ac.jp


Sponsor or person

Institute

Kyorin University School of Medicin

Institute

Department

Personal name



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

the Institutional Review Board of the Kyorin University School of Medicine

Address

6-20-2 Shinkawa, Mitaka, Tokyo

Tel

+81-422-47-5511

Email

rec@ks.kyorin-u.ac.jp


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、虎の門病院


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

60

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

No longer recruiting

Date of protocol fixation

2017 Year 12 Month 01 Day

Date of IRB

2017 Year 12 Month 07 Day

Anticipated trial start date

2018 Year 03 Month 21 Day

Last follow-up date

2025 Year 03 Month 31 Day

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

2023 Year 10 Month 03 Day



Link to view the page

Value
https://center6.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