Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy

NCT ID: NCT02533193

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-08-31

Brief Summary

The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .

Detailed Description

The ERAS programs has been proved to be a useful solutions in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.

But few studies reported about the ERAS programs in the laparoscopic hepatectomy.

The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .

Conditions

Liver Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

enhanced recovery after surgery protocal

ERAS perioperative cares patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.

Group Type: ACTIVE_COMPARATOR

ERAS perioperative cares

Intervention Type: PROCEDURE

1. Patient's preoperative counseling & education before surgery

2. No Bowel preparation

3. Drug: Oral Carbohydrate Solution (OCS). Take 250ml OCS orally 2 hours before surgery

4. Fluid restriction & Management by pulse contour analysis or transesophageal doppler

5. Early mobilization

6. Early oral feeding (postoperative 1 day - liquid diet, 2 days - semifluid diet (SFD), 3 days - normal diet)

7. Intravenous patient controlled analgesics (no opioids analgesics)

8. Postoperative Nausea Active Control

9. No nasogastric tube

10. No drain insertion

11. Patients will be discharged at POD#4 if there's no problem

Conventional perioperative cares

Conventional perioperative cares patents will be managed by our hospital's critical pathways.

Group Type: ACTIVE_COMPARATOR

Conventional perioperative cares

Intervention Type: PROCEDURE

1. No Patient's preoperative counseling & education before surgery

2. Bowel preparation

3. No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery

4. Conventional Fluid Management by clinical signs (Urine output, heart rate etc.)

5. Conventional Mobilization

6. Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD)

7. IV PCA

8. Postoperative Nausea Control if needed

9. No Thromboembolism prophylaxis

10. No or Low Content Oxygen therapy

11. Drainage tube insertion if needed

Interventions

ERAS perioperative cares

1. Patient's preoperative counseling & education before surgery

2. No Bowel preparation

3. Drug: Oral Carbohydrate Solution (OCS). Take 250ml OCS orally 2 hours before surgery

4. Fluid restriction & Management by pulse contour analysis or transesophageal doppler

5. Early mobilization

6. Early oral feeding (postoperative 1 day - liquid diet, 2 days - semifluid diet (SFD), 3 days - normal diet)

7. Intravenous patient controlled analgesics (no opioids analgesics)

8. Postoperative Nausea Active Control

9. No nasogastric tube

10. No drain insertion

11. Patients will be discharged at POD#4 if there's no problem

Intervention Type: PROCEDURE

Conventional perioperative cares

1. No Patient's preoperative counseling & education before surgery

2. Bowel preparation

3. No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery

4. Conventional Fluid Management by clinical signs (Urine output, heart rate etc.)

5. Conventional Mobilization

6. Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD)

7. IV PCA

8. Postoperative Nausea Control if needed

9. No Thromboembolism prophylaxis

10. No or Low Content Oxygen therapy

11. Drainage tube insertion if needed

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• If patients were diagnosed with tumors

1. Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ

2. The tumor location and size do not affect the dissection of hepatic hilar region

3. Tumor size less than 10cm

4. Without portal vein tumor thrombus

5. Without intrahepatic or distant metastasis

• Partial resection or half liver resection
• Willingness to participate in the study
• Able to understand the nature of the study and what will be required of them
• Body mass index of between 18 and 35
• Child-Pugh classification of A to B
• American Society of Anesthesiologists (ASA) grading of I to III

Exclusion Criteria

• Pregnant or lactating women
• Unwillingness to participate
• Inability to give written informed consent
• Child-Pugh classification of C
• ASA grading of IV to V
• Tumor invasion of the inferior vena cava or confluence part of hepatic vein
• Decompensated liver cirrhosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiujun Cai

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

sirrrsh20150802-1

Identifier Type: -

Identifier Source: org_study_id