UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014175 |
|---|---|
| Receipt number | R000016510 |
| Scientific Title | ESSENSE protocol for peri-operative patients management; a multi-center prospective clinical trial |
| Date of disclosure of the study information | 2014/06/15 |
| Last modified on | 2016/06/05 20:05:03 |
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Basic information
Public title
ESSENSE protocol for peri-operative patients management; a multi-center prospective clinical trial
Acronym
ESSENSE protocol for peri-operative patients management; a multi-center prospective clinical trial
Scientific Title
ESSENSE protocol for peri-operative patients management; a multi-center prospective clinical trial
Scientific Title:Acronym
ESSENSE protocol for peri-operative patients management; a multi-center prospective clinical trial
Region
| Japan |
Condition
Condition
Status after high-stress surgical procedure, such as esophagectomy, total or distal gastrectomy, colectomy, hepatectomy and pancreatico-duodenectomy.
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
ESSENSE protocol is extracted from Enhanced Recovery After Surgery (ERAS) protocol established in European society. The purpose of this study is to examine the effectiveness of ESSENSE protocol for the patients physical recovery after high-stress surgical treatment.
"ESSENSE" is an acronym of ESsential Strategy for Early Normalization after Surgery with patient's Excellent satisfaction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Post-operative patients recovery estimated by QoR40 format in 3rd and 7th postoperative days.
Key secondary outcomes
Patient's physical condition estimated by blood test; Albumin, total lymphocyte count, sodium, C-reactive protein and total cholesterol. Number of complications.
Length of hospital stay after surgery.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-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
| Maneuver |
Interventions/Control_1
Patients in the study group will be managed by ESSENSE protocol as indicated below for 6 months. Control group will be managed by standard care protocol in each hospital.
1. Intensive pain control: postoperative pain will be estimated by Prince Henry Hospital pain scale and pain must be reduced to be able enough to cough.
2. Minimization of fasting: 400ml clear fluid will be provided until 2hour before induction of anesthesia and restart drinking since 1st postoperative day. Amount of intake is recorded in ESSENSE diary by medical staff and patients themselves.
3. Early mobilization: walking around the bed is scheduled since 1st postoperative day. Count of steps walking is recorded in ESSENSE diary by patients.
4. Encourage the will of recovery: Physical condition will be conscious by recording ESSENSE diary that is a tool for sharing the goal and the process of recovery among medical staff and patients themselves.
Interventions/Control_2
In contrast of ESSENSE protocol, control group patients will be managed by standard protocol. Pain killer will be administrated according to patient's complaints. Fasting in the day of the operation and restart drinking according to patient's bowel condition. Mobilization will be done voluntary.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who are judged as operable in the individual hospital.
Key exclusion criteria
1.Patients unable to record their physical status in diary.
2.Patients unable to drink from before an operation.
3.Patients unable to walk from before an operation.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Go Miyata |
Organization
Tohoku University, Graduate School of Medicine
Division name
Division of Advanced Surgical Science and Technology
Zip code
Address
Seiryo-machi 1-1, Aoba-ku, Sendai,city, Miyagi pref. JAPAN
TEL
+81-22-717-7214
miyata5@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Go Miyata |
Organization
Japanese Society for Surgical metabolism and nutrition
Division name
Peri-operative management study group
Zip code
Address
Shunkosha Co.Ltd. Ohkubo 2-4-12, Shinjuku-ku, Tokyo, JAPAN
TEL
+81-3-5291-6231
Homepage URL
http://www.jsmmn.jp/essense/index.html
essense@shunkosha.com
Sponsor or person
Institute
Japanese Society for Surgical metabolism and nutrition
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Surgical metabolism and nutrition
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
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
東北大学病院（宮城県）、浜松医療センター（静岡県）、下関医療センター（山口県）、埼玉医大国際医療センター（埼玉県）、小張総合病院（千葉県）、東邦大学医療センター大森病院（東京都）、関西医科大学（大阪府）、那須赤十字病院（栃木県）、横浜中央病院（神奈川県）、県立広島病院（広島県）、市立堺病院（大阪府）、東京慈恵会医科大学付属病院（東京都）、市立池田病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
http://www.jsmmn.jp/essense/index.html
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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 15 | 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
| 2014 | Year | 06 | Month | 05 | Day |
Last modified on
| 2016 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016510
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