UMIN-CTR Clinical Trial

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

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	Obstetrics and Gynecology	Dermatology
Orthopedics	Urology	Cardiovascular surgery
Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Organ causing abdominal pain

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of General Medicine, Saga University Hospital, Japan

Institute

Department

Personal name

Organization

Japan Primary Care Association

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

佐賀大学医学部附属病院/Saga University Hospital

Date of disclosure of the study information

2019

Year

08

Month

15

Day

URL releasing protocol

https://bmjopen.bmj.com/content/10/6/e034446

Publication of results

Published

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

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 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.

Registered date

2019

Year

08

Month

14

Day

Last modified on

2020

Year

08

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042973