UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054391 |
|---|---|
| Receipt number | R000062129 |
| Scientific Title | A multicenter, retrospective cohort study on perforated peptic ulcer treatment |
| Date of disclosure of the study information | 2024/05/14 |
| Last modified on | 2025/11/14 12:14:12 |
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Basic information
Public title
A multicenter, retrospective cohort study on perforated peptic ulcer treatment
Acronym
Perforated Peptic Ulcer Analysis Project
Scientific Title
A multicenter, retrospective cohort study on perforated peptic ulcer treatment
Scientific Title:Acronym
Perforated Peptic Ulcer Analysis Project
Region
| Japan |
Condition
Condition
Perforated peptic ulcer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study epidemiology of Perforated peptic ulcer
To study treatment strategies for perforated peptic ulcer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital mortality
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study included patients aged 18 years old diagnosed with PPU between January 2011 and December 2022.
Key exclusion criteria
We excluded pregnant women, those who opted out of active treatment, patients with malignancy-related and iatrogenic perforations, those who refused to participate, and patients who were considered inappropriate by the research leaders at each facility.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Hoshi |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of Acute Critical Care Medicine
Zip code
300-0028
Address
4-1-1 Otsuno, Tsuchiura-shi, Ibaraki, JAPAN
TEL
029-830-3711
adg3855@gmail.com
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Hoshi |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of Acute Critical Care Medicine
Zip code
300-0028
Address
4-1-1 Otsuno, Tsuchiura-shi, Ibaraki, JAPAN
TEL
029-830-3711
Homepage URL
adg3855@gmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
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
Tsuchiura Kyodo General Hospital
Address
4-1-1 Otsuno, Tsuchiura-shi, Ibaraki, JAPAN
Tel
029-830-3711
general@tkgh.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 14 | 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
703
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
Main results already published
Date of protocol fixation
| 2023 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collected the following patient information: age, sex, year of treatment, facilities for treatment, body mass index, data required to calculate the Charlson comorbidity index, Boey score, and peptic ulcer perforation (PULP) score, history of abdominal surgery, risk factors for PPU (current smoking, alcohol consumption, Helicobacter pylori infection, use of nonsteroidal anti-inflammatory drugs [NSAIDs], and steroid use), use of prophylactics for PPU (proton pump inhibitor, potassium competitive acid blocker, histamine H2 receptor antagonist, and gastric mucosal protective agent), time from onset to hospital visit, meals before hospital visit, presence of sepsis, presence of peritoneal irritation signs and its extent, presence of ascites on computed tomography (CT) and its extent, body temperature, vital signs (systolic blood pressure [SBP] and heart rate [HR]), laboratory data (white blood cell count and C reactive protein, hemoglobin, albumin, and creatinine levels), American Society of Anesthesiologists Physical Status Classification (ASA-PS), treatment (conservative treatment, conversion from conservative treatment to surgery, and surgery), site of perforations, surgical findings (perforation diameter, volume of peritoneal lavage, surgical techniques, number of drains, and surgery duration), postoperative complications, time to start liquid intake, time to start diet intake, length of stay in intensive care unit (ICU), length of stay in hospital, and in-hospital mortality.
Management information
Registered date
| 2024 | Year | 05 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062129
