UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045455 |
|---|---|
| Receipt number | R000051898 |
| Scientific Title | Predictive factors of acute complicated appendicitis: a retrospective study |
| Date of disclosure of the study information | 2021/09/11 |
| Last modified on | 2022/09/12 16:32:50 |
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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
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
oosaji5hai@gmail.com
Sponsor or person
Institute
Hiroshima Prefectural Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051898
