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

NCT01938313 | Completed Phase 2 DMC

• 1 other identifier: SNUBH-ERAS-GC-PII
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

gastric cancer; ERAS (early recovery after surgery); fast track; laparoscopic gastrectomy

Outcome Measures

Primary Outcomes (1)

• Recovering Rate

  1. Tolerance of diet for 24 hours A. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting 2. Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA) 3. Safe ambulation (ambulation of 600m without assistance) 4. Afebrile status without major complications (fever defined as body temperature greater than 37.5) * Above total 4 criteria should be satisfied for the evaluation of complete recovery.

  4 days after surgery

Secondary Outcomes (7)

• Postoperative length of hospital stay

  up to 4 weeks after surgery

• Time to tolerance of a full diet

  up to 1 month after surgery

• Time to first bowel motion Time to first bowel motion

  up to 7 days after surgery

• Complications during the admissionTime to first bowel motion

  up to 30 days after surgery

• Readmission rate

  up to 30 days after surgery

Study Arms (2)

ERAS perioperative cares

ACTIVE COMPARATOR

Patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.

Procedure: ERAS perioperative cares

Conventional perioperative cares

ACTIVE COMPARATOR

Patents will be managed by our hospital's critical pathways.

Procedure: Conventional perioperative cares

Interventions

ERAS perioperative cares 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.

ERAS perioperative cares

Conventional perioperative cares 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

Conventional perioperative cares

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective surgery
• American Society of Anesthesiologists (ASA) scores \< 3
• \< 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

You may not qualify if:

• Emergency operation

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Geynggi, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30051365 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Hyung-Ho Kim, M.D., Ph.D.

  Department of Surgery, SNUBH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2012
• First Posted: September 10, 2013
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: April 1, 2016
• Last Updated: January 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)