UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039228
Receipt number R000044732
Scientific Title The study of the new program, Enhanced Recovery After Surgery (ERAS) protocol, following liver resection
Date of disclosure of the study information 2020/02/01
Last modified on 2020/01/22 15:21:43

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Basic information

Public title

The study of the new program, Enhanced Recovery After Surgery (ERAS) protocol, following liver resection

Acronym

The study of the new program, Enhanced Recovery After Surgery (ERAS) protocol, following liver resection

Scientific Title

The study of the new program, Enhanced Recovery After Surgery (ERAS) protocol, following liver resection

Scientific Title:Acronym

The study of the new program, Enhanced Recovery After Surgery (ERAS) protocol, following liver resection

Region

Japan


Condition

Condition

hepatic tumor

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

we performed a randomized controlled trial (RCT) to investigate whether an ERAS protocol can be effective for recovery compared with traditional postoperative management in patients undergoing open hepatectomy in our department.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

medically fit for discharge

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

preoperative management ERAS group synbiotics(pre operative day 3-), carbohydrate loading (preoperative day 1), no laxative/ Traditional group no synbiotics. no carbohydrate loading, preoperative laxative.

Interventions/Control_2

post operative management ERAS group early removal of naso-gastric tube, early rehabilitation, water permitted on postoperative day 1 and normal diet on postoperative day 2, synbiotics to postoperative day 5/ Traditional group removal of naso-gastric tube on postoperative day 1, rehabilitation at patients will, oral intake after first flatus, no synbiotics.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

All adults presenting for liver resection at our department (Department of Transplantation, Endoscopic and Reconstruction surgery, Tohoku University Hospital) were eligible.

Key exclusion criteria

patients had previously undergone upper digestive surgery, required additional procedures (e.g., bile duct reconstruction), their body mass index was <18 or >30 kg/m2, their performance status was <2,
they did not consent to participate.

Target sample size

36


Research contact person

Name of lead principal investigator

1st name Shigehito
Middle name
Last name Miyagi

Organization

Tohoku University

Division name

Department of surgery

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan

TEL

022-717-7214

Email

msmsmiyagi@yahoo.co.jp


Public contact

Name of contact person

1st name Shigehito
Middle name
Last name Miygai

Organization

Tohoku University

Division name

Department of surgery

Zip code

980-8674

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan

TEL

022-717-7214

Homepage URL


Email

msmsmiyagi@yahoo.co.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

nothing

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku University ethics committee

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan

Tel

022-728-4105

Email

med-kenkyo@grp.tohoku.ac.jp


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

2020 Year 02 Month 01 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

57

Results

his trial did not demonstrate greater efficacy of the ERAS protocol for open hepatectomy regarding MFD and LOHS. However, the ERAS protocol was associated with better recovery from postoperative gastrointestinal paresis, suggesting that it is useful for patients undergoing open hepatectomy.

Results date posted

2020 Year 01 Month 22 Day

Results Delayed

Delay expected

Results Delay Reason

prepare for paper submission

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

2014 Year 02 Month 14 Day

Date of IRB

2014 Year 06 Month 16 Day

Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2017 Year 03 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

2020 Year 01 Month 22 Day

Last modified on

2020 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044732


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name