UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053040 |
|---|---|
| Receipt number | R000060514 |
| Scientific Title | Simple Severity Scale for Perforated Peptic Ulcer with Generalized Peritonitis |
| Date of disclosure of the study information | 2023/12/09 |
| Last modified on | 2023/12/09 00:03:55 |
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Basic information
Public title
Simple Severity Scale for Perforated Peptic Ulcer with Generalized Peritonitis
Acronym
Scale for Perforated Peptic Ulcer
Scientific Title
Simple Severity Scale for Perforated Peptic Ulcer with Generalized Peritonitis
Scientific Title:Acronym
Scale for Perforated Peptic Ulcer
Region
| Japan |
Condition
Condition
Perforated Peptic Ulcer with Generalized Peritonitis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develope a severity scale for PPU with generalized peritonitis
Basic objectives2
Others
Basic objectives -Others
To validate the severity scale for PPU with generalized peritonitis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severe postoperative adverse events
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
| 15 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male
Key inclusion criteria
patients aged older than 15 years
those with PPU in the stomach or duodenum with an ICD-10 code of K25.1, K25.2, K25.5, K25.6, K26.1, K26.2, K26.5, or K26.6
those who underwent laparotomy for generalized peritonitis
Key exclusion criteria
Patients who had co-diagnosis of other gastrointestinal perforation (e.g., perforated diverticulitis) and duplicate cases were excluded
Target sample size
12652
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Yamamoto |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0332251323
ryo.yamamoto@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Yamamoto |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0332251323
Homepage URL
ryo.yamamoto@gmail.com
Sponsor or person
Institute
Keio University
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
Keio University School of Medicine, Institutional Review Board
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 09 | 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
12652
Results
Age, respiratory distress, preoperative sepsis, III/IV/V of American Society of Anesthesiologists physical status, albumin, and creatinine were selected for the final model. The 0-11 scoring system was developed with c-statistics of 0.812-0.819, and the estimated and observed probability of postoperative adverse events gradually increased from 0% at a score of <=2 to >50% at >=8. The score >=5 had 97.5%-97.9% of NPV for postoperative adverse events.
Results date posted
| 2023 | Year | 12 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The cohorts had similar characteristics regardless of the COVID-19 pandemic. More than half of the patients were transported via ambulance (emergency transport), and approximately 95% underwent emergency surgery. Further, <5% of patients presented with comorbidities, whereas the validation cohorts had a relatively higher rate of anticoagulant use than the derivation cohort. Approximately 40% of patients with critical conditions underwent surgery (class III/IV/V based on the ASA-PS classification system).
Participant flow
Among 6043726 patients in the NCD, 12652 aged >=15 years presented with PPU and underwent laparotomy for generalized peritonitis: Therefore, they were eligible to the study. In total, 8998 patients were included in the derivation cohort and 1900 and 1754 in the two validation cohorts.
Adverse events
Outcome measures
Postoperative severe adverse events were observed in 533 (5.9%) patients in the derivation cohort and 138 (7.6%) and 117 (6.9%) in the two validation cohorts. The 30-day mortality rate after surgery and at discharge were 4.3%-5.3% and 6.2%-7.6%, respectively.
Plan to share IPD
Data on individual surgical cases in this study are not publicly available.
IPD sharing Plan description
Data on individual surgical cases in this study are not publicly available. Aggregate data, including data reported in this study, can be accessed by submitting a research plan to the National Clinical Database (NCD) Office and requesting access, commonly via an NCD-related society (such as the Japanese Society of Gastroenterological Surgery). If the proposal is approved, the deidentified data (including participants and related data, if necessary) can be assessed by a statistical specialist affiliated with the NCD.
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a retrospective observational study using data from the National Clinical Database (NCD) in Japan
Management information
Registered date
| 2023 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060514
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
