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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008154
Receipt No. R000009574
Scientific Title Multicenter study of the effect of Elemental diet for Perioperative nutrition in Laparoscopic colorectal Surgery.
Date of disclosure of the study information 2012/06/13
Last modified on 2013/12/20

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Basic information
Public title Multicenter study of the effect of Elemental diet for Perioperative nutrition in Laparoscopic colorectal Surgery.
Acronym EPLAS
Scientific Title Multicenter study of the effect of Elemental diet for Perioperative nutrition in Laparoscopic colorectal Surgery.
Scientific Title:Acronym EPLAS
Region
Japan

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

Objectives
Narrative objectives1 In laparoscopic colorectal surgery, by shortening the length of fasting in perioperative period as much as possible, and performing nutrition management using an elemental diet(Elental), the effect on postoperative recovery, surgical technique, and safety is examined using a clinical parameter, inspection data, a questionnaire, etc.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ratio of patients which fulfilled all the items of the criteria for discharge less than postoperative 7 day.
Key secondary outcomes 1) Dietary intake
2) Rising time
3) QOL
4) Safety
5) Compliance of elemental diet

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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 Elemental diet group:
900mL intake of Elental is performed on the day before surgery. 300mL intake is performed by two and a half hour before the operation as far as possible.
300mL of Elental is taken when the seated position is possible after five hours of operation.
900 mL/day intake of Elental is performed one or two days after surgery as far as possible.
Three days after surgery, dietary intake (rice porridge in half degree) is started and Elental is taken in 300-900 mL/day.
Four days after surgery, rice porridge in full degree is started and medication of Elental is discontinued.
Interventions/Control_2 Control group:
Fasting is performed on the day before surgery and the operation day.
Intake of fluid is only allowed for two days after surgery. Rice porridge in half degree is started three days after a surgery. Rice porridge in full degree is started four days after a surgery.
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

Not applicable
Age-upper limit
76 years-old >
Gender Male and Female
Key inclusion criteria 1) Colorectal cancer characterized by tumor found in the colon and the rectum RS section.
2) A laparoscopic surgery is planned.
3)Patients with histologically proven colorectal cancer.
4) The case diagnosed as having a curative operation
5) Sufficient function of main organ.
6) The age of patients is less than 76 years old when informed consent is obtained.
7) ECOG Performance Status (PS) of 0 or 1.
8) Voluntarily gave the written informed consent.
Key exclusion criteria 1) Ileus, anemia by neoplasm bleeding, and tumor perforation.
2) Patients with the history of chemotherapy, radiotherapy, immunotherapy.
3) Patients with severe complications.
1.uncontrolled diabetes.
2.uncontrolled hypertension.
3.Interstitial pneumonias, pulmonary fibrosis, severe emphysema.
4) Patients at risk for aspiration (Parkinson's Disease, nerve/ myopathy, etc.).
5) Patients have psychosis or psychiatric symptoms and are judged as inappropriate for this study.
6) Judged as inappropriate for this study by the investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Shichinohe
Organization Hokkaido University Hospital
Division name Gastroenterological Surgery II
Zip code
Address West-7, North-15, Kita-ku, Sapporo
TEL 011-706-7714
Email shichino@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Shichinohe
Organization Hokkaido University Hospital
Division name Gastroenterological Surgery II
Zip code
Address West-7, North-15, Kita-ku, Sapporo
TEL 011-706-7714
Homepage URL
Email shichino@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Gastroenterological Surgery II
Institute
Department

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

Other related organizations
Co-sponsor Tonan Hospital, Obihiro-Kosei General Hospital, Hokkaido Gastroenterology Hospital, Sapporo Medical Center NTT EC, Teine Keijinkai Hospital, Steel Memorial Muroran Hospital, and others.
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 北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 13 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 Completed
Date of protocol fixation
2012 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 09 Month 30 Day
Date of closure to data entry
2014 Year 01 Month 30 Day
Date trial data considered complete
2014 Year 02 Month 10 Day
Date analysis concluded
2014 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 13 Day
Last modified on
2013 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009574

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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