ERAS on Postoperative Recovery After Laparoscopic Distal Gastrectomy

Not Applicable

Completed

• Conditions: Enhanced Recovery After Surgery
• Interventions: Procedure: ERAS protocol

• Registration Number: NCT05649319
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-14
• Study Start: 2023-02-03
• Primary Completion: 2024-06-07
• Study Completion: 2024-08-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2025-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS group	ERAS protocol	Perioperative care for laparoscopic distal gastrectomy is managed according to ERAS protocol.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative pain score	postoperative 24, 48, and 72 hours	11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"
Total fentanyl consumption	From the end of surgery to 24, 48, and 72 hours postoperatively	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Postoperative nausea and vomiting	From the end of surgery to 24, 48, and 72 hours postoperatively	Incidence of postoperative nausea and vomiting (%)
Postoperative gastrointestinal dysfunction	postoperative 24, 48, and 72 hours	I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction)
Recovery time	Evaluate every hour starting from 9A on the postoperative day 3 up to discharge	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of