UMIN-CTR Clinical Trial

Basic information
Public title	Predictive factors of acute complicated appendicitis: a retrospective study
Acronym	Predictive factors of acute complicated appendicitis: a retrospective study
Scientific Title	Predictive factors of acute complicated appendicitis: a retrospective study
Scientific Title:Acronym	Predictive factors of acute complicated appendicitis: a retrospective study
Region	Japan

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

Objectives
Narrative objectives1	Predictive factors of acute complicated appendicitis: a retrospective study
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate whether complicated appendicitis and simple appendicitis were correctly distinguished preoperatively by comparing with the pathological findings of acute appendicitis that was the target of surgery.
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	18 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with acute appendicitis
Key exclusion criteria	Patients who are intolerant
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Michinori Middle name Last name Hamaoka
Organization	Hiroshima Prefectural Hospital
Division name	Department of Gastroenterological Surgery
Zip code	723-8530
Address	1-5-54 Ujina-Kanda, Minami-ku, Hiroshima
TEL	082-254-1818
Email	oosaji5hai@gmail.com

Public contact
Name of contact person	1st name Michinori Middle name Last name Hamaoka
Organization	Hiroshima Prefectural Hospital
Division name	Department of Gastroenterological Surgery
Zip code	723-8530
Address	1-5-54 Ujina-Kanda, Minami-ku, Hiroshima
TEL	+81822541818
Homepage URL
Email	oosaji5hai@gmail.com

Sponsor
Institute	Hiroshima Prefectural Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Department of Gastroenterological Surgery, Hiroshima Prefectural Hospital, 1-5-54 Ujina-Kanda, Minami-ku, Hiroshima 734-8530, Japan.
Address	1-5-54 Ujina-Kanda, Minami-ku, Hiroshima
Tel	+81822541818
Email	oosaji5hai@gmail.com

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	2021 Year 09 Month 11 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 01 Month 01 Day
Date of IRB	2021 Year 01 Month 27 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 09 Month 12 Day

Other
Other related information	From the blood sampling and CT results of patients who underwent surgery for acute appendicitis, we will select significant factors for patients with complicated appendicitis and evaluate whether the factors can appropriately identify complicated appendicitis before surgery.

Management information
Registered date	2021 Year 09 Month 11 Day
Last modified on	2022 Year 09 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051898