NCT02644603

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

10 months

First QC Date

December 15, 2015

Last Update Submit

June 24, 2017

Conditions

Carcinoma, Hepatocellular

Keywords

Enhanced Recovery After Surgeryhepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • Treatment related complications

    Number of adverse events that are related to treatment of each patients, and hospital readmission

    Up to 1 month since operation

Secondary Outcomes (16)

  • Length of stay in hospital

    From the day a patient be hospitalized to the day discharged, up to 1 month.

  • Total hospitalization costs

    From the day a patient be hospitalized to the day discharged, up to 1 month.

  • Preoperative and postoperative body weight

    One day before operation, and the day patient discharged, up to 1 month.

  • Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L),

    Day before operation and day 1/3/5 after operation.

  • Albumin (ALB)

    Day before operation and day 1/3/5 after operation.

  • +11 more secondary outcomes

Study Arms (2)

Enhanced Recovery After Surgery

EXPERIMENTAL

Patients underwent ERAS protocol

Procedure: Enhanced Recovery After Surgery

Conventional Treatment

NO INTERVENTION

Patients underwent conventional treatment

Interventions

Enhanced Recovery After SurgeryPROCEDURE

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.

Also known as: Fast Track Surgery
Enhanced Recovery After Surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (3)

  • 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.

    PMID: 16491462BACKGROUND

  • 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.

    PMID: 11222424BACKGROUND

  • 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.

    PMID: 23562361BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, Operative

Study Officials

  • Jian Zhou, MD, PhD

    Shanghai Zhongshan Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2015

First Posted

January 1, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

CN(1)