ERAS (Early Recovery After Surgery) Protocol After Laparoscopic Total Gastrectomy and Proximal Gastrectomy

Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Total Gastrectomy and Proximal Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study)

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

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: ERAS perioperative cares; Procedure: Conventional perioperative cares

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 total gastrectomy and proximal gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Hyung-Ho Kim, M.D. Ph.D.; Phone Number: +82-31-787-7095; Email: hhkim@snubh.org
      • Contact: Ju-Hee Lee, M.D.; Phone Number: +82-31-787-7090; Email: leejuhee79@gmail.com
      • Principal Investigator: Hyung-Ho Kim, M.D.Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective surgery
• American Society of Anesthesiologists (ASA) scores < 3
• Gastric cancer, adenocarcinoma, possible to perform laparoscopic total gastrectomy and proximal 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:

• conversion to open

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ERAS perioperative cares; Patients planned to undergoing laparoscopic total gastrectomy, following the ERAS protocols	Procedure: ERAS perioperative cares; Patient's preoperative counseling & education before surgery No Bowel preparation Oral Carbohydrate Solution (OCS) loading until 2hours before surgery Fluid restriction & Management by pulse contour analysis or transesophageal doppler Early mobilization Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD)) Epidural patient controlled analgesics (no opioids analgesics) Postoperative Nausea Active Control Thromboembolism prophylaxis by low molecular weighted heparin (LMWH) Perioperative High content Oxygen therapy No drain insertion No Levin tube Patients will be discharged at POD#4 if there's no problem.
Active Comparator: Conventional perioperative cares; Patents will be managed by our hospital's critical pathways	Procedure: Conventional perioperative cares; No Patient's preoperative counseling & education before surgery Bowel preparation No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery Conventional Fluid Management by clinical signs (Urine output, heart rate etc.) Conventional Mobilization Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD) IV PCA Postoperative Nausea Control if needed No Thromboembolism prophylaxis No or Low Content Oxygen therapy Routine drain insertion Levin tube insertion if needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance of diet for 24 hours	Tolerance of diet for 24 hours. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting	4 days after surgery
Analgesic-free	Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)	4 days after surgery
Safe ambulation	Safe ambulation (ambulation of 600m without assistance)	4 days after surgery
Afebrile status without major complications	Afebrile status without major complications (fever defined as body temperature greater than 37.5)	4 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative length of hospital stay	Postoperative length of hospital stay	up to 4 weeks after surgery
Time to tolerance of a full diet	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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: gastric cancer; ERAS (early recovery after surgery); laparoscopic total gastrectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: B-1608-357-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No