Effect of Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer

NCT ID: NCT02644603

Last Updated: 2017-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-06-30

Brief Summary

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The purpose of this study is to evaluate Enhanced Recovery After Surgery(ERAS) protocol versus conventional treatment on patients who underwent liver resection for hepatocellular carcinoma(HCC).

Detailed Description

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212 patients are randomly recruited from inpatients of Shanghai Zhongshan Hospital, Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Anhui Provincial Hospital, Subei People's Hospital of Jiangsu Province and Affiliated Tumor Hospital of Nantong University from February 2016 to July 2016. Randomly assigned about half of the patients to receive Enhanced Recovery After Surgery(ERAS) protocol and the other half to receive conventional treatment. Evaluate the safety and efficacy of the ERAS protocol.

Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Enhanced Recovery After Surgery

Patients underwent ERAS protocol

Group Type EXPERIMENTAL

Enhanced Recovery After Surgery

Intervention Type PROCEDURE

Before operation:

Preoperative optimization of organ function, No preoperative bowel preparation, Prohibit eating 6h, drinking water 2h before operation, Oral rehydration before operation.

In operation:

Optimized combined anesthesia, Minimal invasive operations, Normothermia, Minimal use of tubes and drains.

After operation:

Postoperative analgesia and antiemetic, Early mobilization, Oral nutrition, Early and scheduled mobilization.

Conventional Treatment

Patients underwent conventional treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced Recovery After Surgery

Before operation:

Preoperative optimization of organ function, No preoperative bowel preparation, Prohibit eating 6h, drinking water 2h before operation, Oral rehydration before operation.

In operation:

Optimized combined anesthesia, Minimal invasive operations, Normothermia, Minimal use of tubes and drains.

After operation:

Postoperative analgesia and antiemetic, Early mobilization, Oral nutrition, Early and scheduled mobilization.

Intervention Type PROCEDURE

Other Intervention Names

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Fast Track Surgery

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with HCC with indications for surgery
* Without any surgical contraindications
* Under went open liver resection
* Operation ranges less than 4 hepatic segments
* Informed consent

Exclusion Criteria

* Not suitable for surgery
* Benign lesions or other lesions proved by pathology
* Surgical procedure changed during operation or combined evisceration
* Refused to participate or drop out
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Subei People's Hospital of Jiangsu Province

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian Zhou, MD, PhD

Role: STUDY_DIRECTOR

Shanghai Zhongshan Hospital

Locations

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Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Sun HC, Qin LX, Lu L, Wang L, Ye QH, Ren N, Fan J, Tang ZY. Randomized clinical trial of the effects of abdominal drainage after elective hepatectomy using the crushing clamp method. Br J Surg. 2006 Apr;93(4):422-6. doi: 10.1002/bjs.5260.

Reference Type BACKGROUND
PMID: 16491462 (View on PubMed)

Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.

Reference Type BACKGROUND
PMID: 11222424 (View on PubMed)

Ni CY, Yang Y, Chang YQ, Cai H, Xu B, Yang F, Lau WY, Wang ZH, Zhou WP. Fast-track surgery improves postoperative recovery in patients undergoing partial hepatectomy for primary liver cancer: A prospective randomized controlled trial. Eur J Surg Oncol. 2013 Jun;39(6):542-7. doi: 10.1016/j.ejso.2013.03.013. Epub 2013 Apr 4.

Reference Type BACKGROUND
PMID: 23562361 (View on PubMed)

Other Identifiers

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H-ERAS-MRCT-1511

Identifier Type: -

Identifier Source: org_study_id

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