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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010179
Receipt No. R000011920
Scientific Title Usefulness of Heel Drop test for diagnosis of acute appendicitis
Date of disclosure of the study information 2013/03/06
Last modified on 2013/09/22

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Basic information
Public title Usefulness of Heel Drop test for diagnosis of acute appendicitis
Acronym Usefulness of Heel Drop test for diagnosis of acute appendicitis
Scientific Title Usefulness of Heel Drop test for diagnosis of acute appendicitis
Scientific Title:Acronym Usefulness of Heel Drop test for diagnosis of acute appendicitis
Region
Japan

Condition
Condition acute appendicitis
Classification by specialty
Medicine in general Gastroenterology Surgery in general
Gastrointestinal surgery Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison between Heel Drop test and other test (speed bump test, migratory pain, nausea or vomitting, and rebound tenderness) for diagnosis of acute appendicitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assessment of change in the pain by Heel Drop test and Speed bump test
Key secondary outcomes nausea or vomitting, migratory pain,and rebound tenderness

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 In the case that doctor suspects the patients of acute appendicitis, Heel Drop test and Speed bump test are performed for diagnosis of acute appendicitis.
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 * The patient undergoing operation for diagnosis of acute abdomen and acute appnedicitis
* The patient who agree to our study
Key exclusion criteria * Not performed operation
* The patient who is not able to Keep standing. (Heel Drop test can not be performed.)
* The patient is determined not to sultable for our study by doctor.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shimizu Takayuki
Organization Dokkyo Medical University
Division name Second Department of Surgery
Zip code
Address Kitakobayashi880, Mibu, Tochigi, Japan
TEL 0282-87-2158
Email stratstrat1213@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Saito
Organization Dokkyo Medical University
Division name Research Cooperation Division
Zip code
Address Kitakobayashi880, Mibu, Tochigi, Japan
TEL 0282-87-2474
Homepage URL http://w3intra.dokkyomed.ac.jp/modx/jimu-m/kenkyu/364.html
Email kenkyu@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
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

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 06 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
2013 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2013 Year 04 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

Management information
Registered date
2013 Year 03 Month 06 Day
Last modified on
2013 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011920

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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