UMIN-CTR Clinical Trial

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
Last 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
Email	gekaw@med.katasato-u.ac.jp

Public contact
1st 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
Email	h-miura@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025561