UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038600 |
|---|---|
| Receipt number | R000043992 |
| Scientific Title | Single-center retrospective observation study by a propensity score matching analysis about analgesic safety of periodic intravenous infusion of acetaminophen after hepatectomy |
| Date of disclosure of the study information | 2019/11/18 |
| Last modified on | 2020/11/16 23:19:20 |
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Basic information
Public title
Analgesic Safety of Periodic Intravenous Infusion of Acetaminophen After Hepatectomy
Acronym
Analgesic Safety of Periodic Intravenous Infusion of Acetaminophen After Hepatectomy
Scientific Title
Single-center retrospective observation study by a propensity score matching analysis about analgesic safety of periodic intravenous infusion of acetaminophen after hepatectomy
Scientific Title:Acronym
Examination of the postoperative pain control method with periodic intravenous infusion of acetaminophen after hepatectomy
Region
| Japan |
Condition
Condition
Hepatectomy without biliary reconstruction
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the analgesic safety of periodic intravenous infusion of acetaminophen following hepatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Investigation of the analgesic safety of periodic intravenous infusion of acetaminophen following hepatectomy
Key secondary outcomes
Postoperative liver enzyme concentrations
Postoperative complications
postoperative hospital stays
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent hepatectomy without biliary reconstruction at St. Marianna University Hospital since January 2014.
Key exclusion criteria
Patients who suffered postoperative infectious complication and/or postoperative bleeding.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Katayama |
Organization
St. Marianna University School of Medicine
Division name
Division of Gastroenterological and General Surgery
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL
+81-44-977-8111
masafumi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Katayama |
Organization
St. Marianna University School of Medicine
Division name
Division of Gastroenterological and General Surgery
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL
+81-44-977-8111
Homepage URL
masafumi@marianna-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterological and General Surgery, St. Marianna University School of Medicine
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
Institutional Review Board of St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
Tel
+81-44-977-8111
k-sienbu.mail@marianna-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
聖マリアンナ医科大学病院（神奈川県） St. Marianna University Hospital, Kanagawa
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
DOI: 10.33425/2639-9334.1038
Number of participants that the trial has enrolled
92
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 12 | Month | 22 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 29 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 29 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 29 | Day |
Other
Other related information
The study included the patients who had undergone hepatectomy without biliary reconstruction at St. Marianna University Hospital since January 2014. These patients were identified from among a larger group of patients, and propensity score matching allowed for the creation of two study groups: the patients who had undergone periodic intravenous infusion of acetaminophen for postoperative pain management, and the control patients who had undergone bolus injections of the non-steroidal anti-inflammatory drug upon request. The two groups were compared retrospectively in terms of clinical characteristics; operative variables; details regarding postoperative analgesia; concentrations of serum liver enzymes and in-hospital outcomes and complications.
Management information
Registered date
| 2019 | Year | 11 | Month | 16 | Day |
Last modified on
| 2020 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043992
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| Registered date | File name |
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