UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037686
Receipt No. R000042973
Scientific Title The relationships between site of abdominal pain and the organs involved; A prospective observational study
Date of disclosure of the study information 2019/08/15
Last modified on 2020/08/13 (Ver. 4)

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Basic information
Public title The relationships between site of abdominal pain and the organs involved; A prospective observational study
Acronym The relationships between site of abdominal pain and the organs involved; A prospective observational study
Scientific Title The relationships between site of abdominal pain and the organs involved; A prospective observational study
Scientific Title:Acronym Site of abdominal pain and diagnosis
Region
Japan

Condition
Condition Disease causing abdominal pain
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Nephrology
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Obsterics and gynecology Dermatology
Orthopedics Urology Cardiovascular surgery
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Determine positive and negative likelihood ratios of the relationships between sites of abdominal pain and the organs involved
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Organ causing abdominal pain
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
120 years-old >=
Gender Male and Female
Key inclusion criteria All subjects are new outpatients aged over 20 years who visit the department of general medicine or the emergency room without using emergency service systems such as an ambulance or a medi-helicopter and have abdominal pain as a chief complaint or one of their symptoms.
Key exclusion criteria None
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Tago
Organization Saga University Hospital
Division name Department of General Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga, Japan
TEL 0952343238
Email tagomas@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Tago
Organization Saga University Hospital
Division name Department of General Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga, Japan
TEL 0952343238
Homepage URL https://www.hospital.med.saga-u.ac.jp/chiken/patient/open/general.html
Email tagomas@cc.saga-u.ac.jp

Sponsor
Institute Department of General Medicine, Saga University Hospital, Japan
Institute
Department

Funding Source
Organization Japan Primary Care Association
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 Department of General Medicine, Saga University Hospital
Address 5-1-1 Nabeshima, Saga 849-8501, Japan
Tel 0952-34-3400
Email kenkyu-shinsei@ml.cc.saga-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 佐賀大学医学部附属病院/Saga University Hospital

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 15 Day

Related information
URL releasing protocol https://bmjopen.bmj.com/content/10/6/e034446
Publication of results Published

Result
URL related to results and publications https://bmjopen.bmj.com/content/10/6/e034446
Number of participants that the trial has enrolled 326
Results 
The positive likelihood ratios between right subcostal and liver and biliary tract (LB), right subcostal and musculoskeletal, epigastric and esophagus, stomach, and duodenum (ESD), right or left flank and urinary tract, left flank and dermatological, mid-lower and intestinal ranged from 2.17 to 4.14. The positive likelihood ratios between epigastric and urinary tract, mid-lower and LB, periumbilical and urinary tract, generalized abdomen and ESD ranged from 0.17 to 0.25.
Results date posted
2020 Year 08 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
The mean patient age was 51.7 years and 141 patients (43.3%) were men. Of the 326 patients included in the study, 126 (38.6%) had been referred to our department either by another hospital (73.8%), another department of our hospital (22.2%), or by general practitioners working at community health centers (4.0%). A total of 209 (64.1%) patients visited during the daytime, 18 (8.6%) of whom visited during a national public holiday and who were thus considered as outside normal office hours patients in accordance with our hospital procedures. Attempts were made to reach 81 of the 326 patients in the study by telephone (24.8%), and 22 of these patients (6.7% of the total study sample) could not be reached. Of the types of examinations planned at the first visit in the present study, which might also be performed at the last visit to facilitate diagnosis and treatment, abdominal CT was performed in nearly half of the patients (47.5%). One hundred forty-five patients (44.5%) were admitted to or followed up by the department of General Medicine, 75 patients (23.0%) were admitted to or followed up by other departments in our hospital, and 46 patients (14.1%) were admitted to or followed up by other hospitals.
Participant flow 
A total of 2591 new outpatients visited the Department of General Medicine at a university hospital from April 2017 to March 2018. Of these, 326 patients aged over 20 years with abdominal pain were enrolled.
Adverse events 
None
Outcome measures 
The positive and negative likelihood ratios of the relationships between the sites of abdominal pain and the organs involved
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
2017 Year 03 Month 09 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2018 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information first visit, the date of that first visit, age, sex, whether they resided with or without housemates, whether they had been referred from another hospital, the time of the hospital visit (day time or outside normal office hours), sites of abdominal pain, and characteristics of abdominal pain are surveyed. Patients who lived in nursing-care facilities are included in the with housemates group. Sites of abdominal pain are classified into 11 categories including 9 different abdominal sections (right or left-subcostal, right or left-flank, right or left-lower, epigastric, periumbilical, and mid-lower), generalized abdominal, and site-indeterminate. When patients have multiple sites of pain or organs involved, classification and analysis of all of them are performed.
At the more than 3 months after the initial visit, two physicians independently determine diagnoses for individual patients based on all information in the health records. The diagnoses are made with reference to the International Statistical Classification of Diseases and Related Health Problems-10. When the diagnosis is the same between the two physicians, the diagnosis is accepted as final diagnosis. When the diagnosis is different, three physicians discuss and make a diagnosis. The organs involved are determined according to the diagnoses, which sometimes overlap with two more organs.

Management information
Registered date
2019 Year 08 Month 14 Day
Last modified on
2020 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042973