UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049250 |
|---|---|
| Receipt number | R000054471 |
| Scientific Title | Effect of scheduled intravenous acetaminophen for laparoscopic-assisted colectomy in postoperative management: A prospective study. |
| Date of disclosure of the study information | 2022/10/19 |
| Last modified on | 2022/10/18 12:07:26 |
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Basic information
Public title
Effect of scheduled intravenous acetaminophen for laparoscopic-assisted colectomy in postoperative management: A prospective study.
Acronym
Effect of regular administration of analgesics on pain
Scientific Title
Effect of scheduled intravenous acetaminophen for laparoscopic-assisted colectomy in postoperative management: A prospective study.
Scientific Title:Acronym
Effect of regular administration of analgesics on pain
Region
| Japan |
Condition
Condition
Patients undergoing laparoscopic-assisted colorectal resection
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A prospective study was performed to elucidate the relationship between pain due to regular administration of acetaminophen and its effect on rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative NRS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
scheduled injection
Interventions/Control_2
single injection
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
Patients diagnosed with colorectal cancer and undergoing laparoscopic-assisted colorectal resection in our hospital (excluding recurrence)
Key exclusion criteria
1.Under 18 years of age
2.American Society of Anesthesiology (ASA) class 3 or higher
3.Laparotomy (abdominal surgery) patient
4.Patients who are difficult to assess for each measurement
5.An individual with an AST or ALT elevation of more than 3 digits
6.Surgery exceeding 6 hours
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Yoshsnobu |
| Middle name | |
| Last name | Kameyama |
Organization
Sendai City Hospital
Division name
Department of Anesthesiology
Zip code
982-8502
Address
1-1-1, Asutonagamachi, Taihaku-ku, Sendai
TEL
022-308-7111
y.kame1116@mac.com
Public contact
Name of contact person
| 1st name | Yoshsnobu |
| Middle name | |
| Last name | Kameyama |
Organization
Sendai City Hospital
Division name
Department of Anesthesiology
Zip code
982-8502
Address
1-1-1, Asutonagamachi, Taihaku-ku, Sendai
TEL
022-308-7111
Homepage URL
y.kame1116@mac.com
Sponsor or person
Institute
Sendai City Hospital
Institute
Department
Personal name
Funding Source
Organization
Sendai City Hospital, department of anesthesiology
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
Sendai City Hospital
Address
1-1-1, Asutonagamachi, Taihaku-ku, Sendai
Tel
022-308-7111
y.kame1116@mac.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
| 2022 | Year | 10 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 18 | Day |
Last modified on
| 2022 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054471
| 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 |
