ERAS on Postoperative Recovery After Laparoscopic Distal Gastrectomy

Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Laparoscopic Distal Gastrectomy: An Open-labeled Randomized Controlled Study

This prospective, randomized, open-labeled study is designed to evaluate the impact of enhanced recovery after surgery (ERAS) protocol on postoperative quality of recovery in patients undergoing laparoscopic distal gastrectomy. We hypothesize that our ERAS protocol can significantly improve the postoperative quality of recovery in patients with laparoscopic distal gastrectomy.

Study Overview

• Status: Completed
• Conditions: Enhanced Recovery After Surgery
• Intervention / Treatment: Procedure: ERAS protocol

Detailed Description

Adult patients undergoing elective laparoscopic distal gastrectomy are randomly allocated to receive the ERAS protocol (n=49) or conventional protocol (n=49). The conventional groups receive our current perioperative management. The ERAS groups receive our new ERAS protocol including preoperative carbohydrate loading, shortening of perioperative fasting time, and multimodal opioid-sparing analgesia. The primary outcome measure was the postoperative quality of recovery evaluated using the Korean version of Quality of recovery-15 at 24, 48, and 72 hours postoperatively. The secondary outcome measures were pain intensity at rest and during coughing evaluated using an 11-point numeric rating scale at 24, 48, and 72 hours postoperatively, gastrointestinal dysfunction evaluated using the I-FEED score at 24, 48, and 72 hours postoperatively, the occurrence of postoperative nausea and vomiting during the first postoperative 24 hours, postoperative 24 to 48 hour period, and postoperative 48 to 72 hour period, the occurrence of major postoperative complications according to the Clavien-Dindo classification during hospitalization, and length of hospital stay.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, KS013
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients scheduled to undergo elective laparoscopic distal gastrectomy
• American Society of Anesthesiologists (ASA)physical classification I-II
• ECOG Performance Status Scale 0 or 1
• Willingness and ability to sign an informed consent document

Exclusion Criteria:

• Patients with chronic pain
• Gastrectomy with combined resection of other organs
• Patients with history of upper abdominal surgery
• Allergies to anesthetic or analgesic medications (fentanyl, ropivacaine, acetaminophen, NSAIDs)
• Medical or psychological disease that can affect the treatment response

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
Experimental: ERAS group; Perioperative care for laparoscopic distal gastrectomy is managed according to ERAS protocol.	Procedure: ERAS protocol; The ERAS protocol involves a pre-admission patient education using audiovisual videos, the reduction of perioperative fasting time with administration of preoperative carbohydrate loading and early resumption of oral feeding after surgery, multimodal postoperative nausea and vomiting prevention, early removal of the nasogastric tube and urinary catheter, and multimodal analgesia to minimize opioid consumption after surgery.
No Intervention: Conventional group; Perioperative care for laparoscopic distal gastrectomy is managed according to our current perioperative practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the Quality of recovery-15 during the first 72 hours after surgery	Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"	postoperative 24, 48, and 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score	11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"	postoperative 24, 48, and 72 hours
Postoperative gastrointestinal dysfunction	I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction)	postoperative 24, 48, and 72 hours
Total fentanyl consumption	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia	From the end of surgery to 24, 48, and 72 hours postoperatively
Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting (%)	From the end of surgery to 24, 48, and 72 hours postoperatively
Recovery time	Postoperative time satisfying the following four criteria: (1) tolerance of soft blended diet (SBD) for 24 h; (2) safe ambulation of 600 m without assistance; (3) Adequate pain control (NRS ≤ 3) with oral non opioid analgesics; and (4) No abnormal physical findings or laboratory test	Evaluate every hour starting from 9A on the postoperative day 3 up to discharge

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Do Joong Park, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2023
• Primary Completion (Actual): June 7, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Enhanced Recovery After Surgery; Stomach Neoplasms; Gastrectomy; Pain, Postoperative
• Other Study ID Numbers: 2207-206-1346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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