UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008154 |
|---|---|
| Receipt number | 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 16:26:28 |
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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
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
shichino@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Gastroenterological Surgery II
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009574
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