The Impact of Fast-track Perioperative Program After Liver Resection in Hong Kong Chinese Patients

NCT03223818 | Unknown DMC

• 1 other identifier: Fast-track_Liver Resection
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Liver cancer was the third leading cause of cancer death in both sexes in Hong Kong and liver resection remains the mainstay of curative treatment. Post-operative recovery from liver resection has historically been fraught with a high incidence of complications, ranging from 15-48%, and the high incidence of complications leads to prolonged hospital stay, ranging from 9 - 15 days, and increase costs of hospitalization. Recent advancement in the perioperative surgical and anesthetic management of patients undergoing liver resection has led to improvement in these outcomes. The investigators department had previously studied the impact and confirmed the benefit of fast-track peri-operative programs after laparoscopic colorectal surgery. Nevertheless, studies regarding its adoption in liver resection are limited. The investigators group had previously reported, in a retrospective cohort, that successful implementation of ERAS protocol was associated with a significantly shorten hospital stay. However, the peri-operative management in that study incorporated a small proportion of components described in ERAS programs for liver resection and there was no direct comparison with conventional peri-operative program. The aim of this study is to compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing liver resection for liver cancer with a "conventional" vs a "fast-track" perioperative program.

Conditions

Liver Cancer

Keywords

Liver; Digestive system

Outcome Measures

Primary Outcomes (1)

• Length of post-operative hospital Stay

  Post-operative hospital stay.

  3 months

Study Arms (2)

Fast-track Arm

EXPERIMENTAL

Patients recruited will undergo ERAS perioperative program.

Other: Fast-track peri-operative program

Conventional Group

NO INTERVENTION

Patients recruited to conventional group will undergo conventional perioperative program

Interventions

Fast-track peri-operative program OTHER

Patients who are scheduled for elective liver resection will be screened in clinic or in wards for the eligibility for ERAS program. Patient will then visit a nurse-led clinic for pre-operative assessment of risk adjustment and education. A guided tour on surgical ward and an information booklet about preoperative management will be given. All patients will receive local infiltration of local anaesthesia (0.25% levobupivacaine) followed by continuous wound instillation using the On-Q PainBuster System balloon pump. Pain control will be supplemented by using opioid-sparing multimodal analgesia.

Also known as: Enhanced recovery after surgery(ERAS) peri-operative program

Fast-track Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive patients undergoing elective liver resection (open and laparoscopic).
• Age of patients between 18 and 70 years.
• Patients with American Society of Anaesthesiologists (ASA) grading I-II.
• Patients with no severe physical disability.
• Patients who require no assistance on the activities of daily living.
• Informed consent available will be recruited.

You may not qualify if:

• Patients undergoing emergency surgery.
• Patients who had received pre-operative portal vein embolization.
• Patients who are expected to receive concomitant procedures other than cholecystectomy.
• Pregnant ladies and patients who are mentally incapable of written consent will be excluded.
• Patient who had previous history of Hepato-biliary and pancreatic surgery.
• Patient who had chronic pain syndrome.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Surgery

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

CHING NING CHONG

CONTACT

2632 1496; chongcn@surgery.cuhk.edu.hk

CREC

CONTACT

crec@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: July 21, 2017
• Study Start: July 1, 2018
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2025
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)