UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053392 |
|---|---|
| Receipt number | R000060901 |
| Scientific Title | Prediction of Postoperative Complications in Digestive Surgery with Cervical and Thoracic Operations: A Retrospective Study of the Improvement of POSSUM and E-PASS and Its Significance |
| Date of disclosure of the study information | 2024/01/18 |
| Last modified on | 2024/01/18 19:45:34 |
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Basic information
Public title
Prediction of Postoperative Complications in Digestive Surgery with Cervical and Thoracic Operations: A Retrospective Study of the Improvement of POSSUM and E-PASS and Its Significance
Acronym
Prediction of Postoperative Complications in Digestive Surgery with Cervical and Thoracic Operations: A Retrospective Study of the Improvement of POSSUM and E-PASS and Its Significance
Scientific Title
Prediction of Postoperative Complications in Digestive Surgery with Cervical and Thoracic Operations: A Retrospective Study of the Improvement of POSSUM and E-PASS and Its Significance
Scientific Title:Acronym
Prediction of Postoperative Complications in Digestive Surgery with Cervical and Thoracic Operations: A Retrospective Study of the Improvement of POSSUM and E-PASS and Its Significance
Region
| Japan |
Condition
Condition
All diseases (including malignant tumors and benign diseases) that are subject to gastrointestinal surgery with neck and thoracic operations
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Oto-rhino-laryngology |
| Cardiovascular surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will retrospectively examine the usefulness of POSSUM (Physiological and Operative Severity Score for enUmeration of Mortality and morbidity) and E-PASS ( Estimation of Physiologic and Surgical Stress) as predictors of postoperative complications.
Basic objectives2
Others
Basic objectives -Others
Postoperative complications and other outcomes (length of hospital stay, prognosis) will be examined, and the by-products (impact on length of hospital stay and prognosis) of postoperative complication prediction and countermeasures will also be examined retrospectively.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in both prediction accuracy and usefulness of appropriate postoperative complication prediction formulas in gastrointestinal surgery with neck to chest manipulation through improvements in POSSUM and E-PASS.
Key secondary outcomes
By-products (impact on length of hospital stay and prognosis) resulting from postoperative complication prediction and countermeasures
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
1) Gastrointestinal surgery under general anesthesia with cervical to thoracic manipulation after July 1, 2005 and before December 31, 2023.
2) Surgeries requiring gastrointestinal surgical support including cervical to thoracic manipulation, regardless of whether it is benign or malignant, are covered.
2) General anesthesia surgery cases.
3) The patient must be at least 18 years of age at the time of surgery.
Key exclusion criteria
1) Surgeries involving cervical to thoracic manipulation that can be completed in cardiovascular surgery, respiratory surgery, and otorhinolaryngology, regardless of gastrointestinal surgery, will be excluded.
2) Cases in which refusal to participate is communicated after disclosure of opt-out will be excluded.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hikota |
| Middle name | |
| Last name | Hayashi |
Organization
Faculty of Mediceine, Shimane University
Division name
Department of Digestive and General Surgery
Zip code
693-8501
Address
89-1 Enya-cho, Izumo City, Shimane Prefecture
TEL
0853-20-2232
hikota@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Hikota |
| Middle name | |
| Last name | Hayashi |
Organization
Faculty of Medicine, Shimane University
Division name
Department of Digestive and General Surgery
Zip code
683-8501
Address
89-1, Enya-cho, Izumo City, Shimane, Japan
TEL
0853-20-2232
Homepage URL
hikota@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane 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
Medical Research Ethics Committee,Shimane University Faculty of Medicine
Address
89-1, Enya-cho, Izumo City, Shimane, Japan
Tel
0853-20-2515
kenkyu@med.shimane-u.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
| 2024 | Year | 01 | Month | 18 | 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
| 2024 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060901
