UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024358
Receipt No. R000027970
Scientific Title Randomized clinical trial on patient-controlled epidural analgesia versus intravenous patient-controlled analgesia for laparoscopiccoloectomy within an enhanced recovery pathway.
Date of disclosure of the study information 2016/10/11
Last modified on 2016/10/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized clinical trial on patient-controlled epidural analgesia versus intravenous patient-controlled analgesia for laparoscopiccoloectomy within an enhanced recovery pathway.
Acronym RCT on PCEA vs iv-PCA for laparoscopic colorectomy within an enhanced recovery pathway
Scientific Title Randomized clinical trial on patient-controlled epidural analgesia versus intravenous patient-controlled analgesia for laparoscopiccoloectomy within an enhanced recovery pathway.
Scientific Title:Acronym RCT on PCEA vs iv-PCA for laparoscopic colorectomy within an enhanced recovery pathway
Region
Japan

Condition
Condition Colon cancer
Classification by specialty
Gastrointestinal surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate a novel method for perioperative pain control by conducting a comparative study to assess the restorative efficacy of patient-controlled epidural analgesia versus intravenous patient-controlled analgesia for laparoscopic coloectomy within an enhanced recovery pathway
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Medical recovery defined as the fulfillment of all the 3 following criteria: (1) sufficient pain control by oral analgesics, (2) fully mobilized or at least comparable with preoperative status, and (3) tolerance of oral
food that was defined as two thirds or more of normal meal (hospital portion)
Key secondary outcomes 1.Time periods of anesthesia in preparation for and during surgery
2.Pain score (VAS) during the first to fifth postoperative day
3.Postoperative general status
4.Total dose of analgesic drug used for PCEA / iv-PCA
5.Frequency of additional analgesic drug use for pain control
6.Occurrence rate and severity of adverse effects
7.Postoperative hospital stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pain control by epidural anesthesia with continuing administration of 0.125% levobupivacaine hydrochloride for 48 hours after surgery allowing the patient-controlled analgesia with bolus injection of 3ml of 0.125% levobupivacaine
Interventions/Control_2 Pain control by intravenous patient-controlled analgesia with continuing administration of fentanyl(0.3-0.5microg/kg/hr) for 48 hours after surgery allowing the patient-controlled analgesia with bolus injection(0.4-0.6microg/kg/bolus)
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Colon cancer patients
2. Histologically proven adenocarcinoma of the rectum
3. Adequate organ function
4. Performance status (PS) 0-2
5. Indication for laparoscopic surgery
6. Written informed consent
Key exclusion criteria 1. Indication for laparotomy
2. Indication for combined resection
3. Emergency case
4. With high risk factors for treatment delay of wound (active infection, uncontrolled diabetes mellitus, severe renal dysfunction, usage of immunosuppressive agent )
5. Contraindication of PCEA
6. Contraindication of iv-PCA
7. Common use with drugs affecting pain control
8. With interstitial lung disease or pulmonary fibrosis
9. Pregnant
10. Patients who do not give written informed consent.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Nakamura,MD
Organization Graduate School of Medical Sciences, Kyushu University
Division name Surgery and Oncology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5437
Email mnaka@surg1.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Manabe,MD
Organization Graduate School of Medical Sciences, Kyushu University
Division name Surgery and Oncology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5440
Homepage URL
Email manabe@surg1.med.kyushu-u.ac.jp

Sponsor
Institute Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of anesthesia in Kyushu University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 10 Month 11 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
2016 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 11 Day
Last modified on
2016 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027970

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.