Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy

NCT ID: NCT01938313

Last Updated: 2017-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-04-30

Brief Summary

Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.

Detailed Description

There is strong evidence of the usefulness of the ERAS programs 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.

However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.

The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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. Oral Carbohydrate Solution (OCS) loading until 2hours before surgery

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

5. Early mobilization

6. Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD))

7. Epidural patient controlled analgesics (no opioids analgesics)

8. Postoperative Nausea Active Control

9. Thromboembolism prophylaxis by low molecular weighted heparin (LMWH)

10. Perioperative High content Oxygen therapy

11. No drain insertion

12. No Levin tube

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

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. Routine drain insertion

12. Levin tube insertion if needed

Interventions

ERAS perioperative cares

1. Patient's preoperative counseling & education before surgery

2. No Bowel preparation

3. Oral Carbohydrate Solution (OCS) loading until 2hours before surgery

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

5. Early mobilization

6. Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD))

7. Epidural patient controlled analgesics (no opioids analgesics)

8. Postoperative Nausea Active Control

9. Thromboembolism prophylaxis by low molecular weighted heparin (LMWH)

10. Perioperative High content Oxygen therapy

11. No drain insertion

12. No Levin tube

13. 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. Routine drain insertion

12. Levin tube insertion if needed

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Elective surgery
• American Society of Anesthesiologists (ASA) scores < 3
• 20 < Age < 80
• Gastric cancer, adenocarcinoma, possible to perform laparoscopic distal gastrectomy
• Informed consent
• No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer.
• No systemic inflammatory disease

Exclusion Criteria

• Emergency operation

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyung-Ho Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyung-Ho Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, SNUBH

Locations

Seoul National University Bundang Hospital

Seongnam, Geynggi, South Korea

Countries

South Korea

References

Kang SH, Lee Y, Min SH, Park YS, Ahn SH, Park DJ, Kim HH. Multimodal Enhanced Recovery After Surgery (ERAS) Program is the Optimal Perioperative Care in Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Cancer: A Prospective, Randomized, Clinical Trial. Ann Surg Oncol. 2018 Oct;25(11):3231-3238. doi: 10.1245/s10434-018-6625-0. Epub 2018 Jul 26.

Reference Type: DERIVED

PMID: 30051365 (View on PubMed)

Other Identifiers

SNUBH-ERAS-GC-PII

Identifier Type: -

Identifier Source: org_study_id