UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022190 |
|---|---|
| Receipt number | R000025561 |
| Scientific Title | Randomized Clinical Trial on Epidural Analgesia Versus Patient-controlled Analgesia Using Acetaminophen for Laparoscopic Colorectal Surgery |
| Date of disclosure of the study information | 2016/05/02 |
| Last modified on | 2019/05/07 11:45:05 |
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Basic information
Public title
Randomized Clinical Trial on Epidural Analgesia Versus Patient-controlled Analgesia Using Acetaminophen for Laparoscopic Colorectal Surgery
Acronym
ACELAC trial
Scientific Title
Randomized Clinical Trial on Epidural Analgesia Versus Patient-controlled Analgesia Using Acetaminophen for Laparoscopic Colorectal Surgery
Scientific Title:Acronym
ACELAC trial
Region
| Japan |
Condition
Condition
Patients undergoing laparoscopic colorectal surgery
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare epidural analgesia that is mainstay of postoperative pain management to intravenous infusion of acetaminophen regarding postoperative recovery in patients undergoing laparoscopic colorectal surgery.
Basic objectives2
Others
Basic objectives -Others
effectivenes
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Medical recovery is determined by the following criteria.
1. Recovery of motor function (period of time required for the status at least comparable with the one in preoperative time, or period of time required for the first time walking after surgery)
2. Recovery of the function of digestive system (period of time required for the first time feces and flatus after surgery).
3. Pain control (period of time required for the switch to oral analgesia, and the number of time subjects use analgesics)
Key secondary outcomes
1. Influence on inflammatory response following laparoscopic colorectal surgery
2. Adverse effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Epidural Analgesia(EDA)
Interventions/Control_2
Intravenous infusion of acetaminophen
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects must fulfill all of the following inclusion criteria and be judged eligible for enrollment of the study by the investigator.
1) Subjects diagnosed as colonial disease with the need of surgery and having laparoscopic colorectal surgery.
2) Subjects who do not need simultaneous resection of multiple lesions with preoperative medical evaluation by endoscopy and image inspection.
3) Subjects older than 20 years old when obtaining informed consent.
4) Subjects with sufficient function of main organs.
5) Subjects with a written, signed, and dated informed consent for the study.
Key exclusion criteria
Subjects are excluded from the study by the following criteria. The investigator must ensure the criteria at the time of enrollment unless otherwise specified.
1) Any subjects with a past history of anaphylaxis due to acetaminophen.
2) Any subjects contraindicated to use acetaminophen.
3) Any subjects with conditions of severe hepatic, renal, and heart dysfunction, and infections.
4) Any subjects assumed to be adversely affected by pharmacological effects of acetaminophen.
5) Any subjects assumed to have difficulty in epidural analgesia.
6) Any subjects with high possibility of need for abdominal surgery during laparoscopic colorectal surgery.
7) Any subjects judged not eligible for enrollment of the study other than any of the above reasons by the investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Depretment of Surgery
Zip code
252-0375
Address
1-15-1,Kitasato, Minami, Sagamihara, Kanagawa, Japan
TEL
+81-42-778-8111
gekaw@med.katasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirohisa |
| Middle name | |
| Last name | Miura |
Organization
Kitasato University School of Medicine
Division name
Depretment of Surgery
Zip code
252-0375
Address
1-15-1,Kitasato, Minami, Sagamihara, Kanagawa, 252-0375 Japan
TEL
+81-42-778-8111
Homepage URL
h-miura@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
TERMO CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Anesthesiology , Kitasato University School of Medicine
Clinical Trial Center, Kitasato University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Hospital Institutional Review Board
Address
1-15-1,Kitasato, Minami, Sagamihara, Kanagawa, 252-0375 Japan
Tel
+81-42-778-9965
chiken@kitasato-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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 02 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025561
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