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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028240
Receipt No. R000032133
Scientific Title Phase II clinical trial of multimodal analgesia for postoperative pain management in patients undergoing laparoscopic colorectal resection for cancer
Date of disclosure of the study information 2017/07/14
Last modified on 2019/08/31

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Basic information
Public title Phase II clinical trial of multimodal analgesia for postoperative pain management in patients undergoing laparoscopic colorectal resection for cancer
Acronym Phase II clinical trial of multimodal analgesia in patients undergoing laparoscopic colorectal resection
Scientific Title Phase II clinical trial of multimodal analgesia for postoperative pain management in patients undergoing laparoscopic colorectal resection for cancer
Scientific Title:Acronym Phase II clinical trial of multimodal analgesia in patients undergoing laparoscopic colorectal resection
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery Anesthesiology
Operative medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the use of a multimodal analgesia in patients undergoing laparoscopic colorectal resection for cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative stay
Key secondary outcomes Pain score (NRS,PRS), postoperative complications, frequency of PCA, time to walk, time to food intake

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Multimodal analgesia
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria # Pathologically proven carcinoma.
# Primary tumor located at colon or upper rectum
# Rectal cancers of which the lower border is located below the peritoneal reflection are excluded.
# Aged 20 to 85 years old
# Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
# Written informed consent
Key exclusion criteria # Allergy to any drugs used in this trial
Distant metastases
# Interstitial pneumonia or fibroid lung.
# Uncontrolled diabetes mellitus.
# Uncontrolled hypertension
# Uncontrolled urinary disorder
# Unable to provide informed consent
# Those considered inappropriate for participation in this trial.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichiro Kawamura
Organization Kindai University
Division name Surgery
Zip code
Address 377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
TEL 072-366-0221
Email kawamuraj@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shohko Matsukawa
Organization Kindai University
Division name Surgery
Zip code
Address 377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
TEL 072-366-0221
Homepage URL
Email profsec-matsukawa@surg.med.kindai.ac.jp

Sponsor
Institute Kindai University Faculty of Medicine
Department of Surgery
Institute
Department

Funding Source
Organization Kindai University Faculty of Medicine
Department of Surgery
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
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
2017 Year 07 Month 14 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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 10 Day
Date of IRB
2017 Year 07 Month 10 Day
Anticipated trial start date
2017 Year 07 Month 14 Day
Last follow-up date
2019 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
2017 Year 07 Month 14 Day
Last modified on
2019 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032133

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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