UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	ESSENSE protocol for peri-operative patients management; a multi-center prospective clinical trial
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Go Miyata
Organization	Tohoku University, Graduate School of Medicine
Division name	Division of Advanced Surgical Science and Technology
Address	Seiryo-machi 1-1, Aoba-ku, Sendai,city, Miyagi pref. JAPAN
TEL	+81-22-717-7214
Email	miyata5@med.tohoku.ac.jp

Public contact
Name of contact person	Go Miyata
Organization	Japanese Society for Surgical metabolism and nutrition
Division name	Peri-operative management study group
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
Email	essense@shunkosha.com

Sponsor
Institute	Japanese Society for Surgical metabolism and nutrition
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 04 Month 01 Day
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

Related information
URL releasing protocol	http://www.jsmmn.jp/essense/index.html
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016510