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Completed

NCT Number: NCT05649319

ERAS on Postoperative Recovery After Laparoscopic Distal Gastrectomy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERAS protocol

Procedure

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.

Primary outcomes

  1. Change of the Quality of recovery-15 during the first 72 hours after surgery

    Time frame: postoperative 24, 48, and 72 hours

    Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"

Secondary outcomes

  1. Postoperative pain score

    Time frame: postoperative 24, 48, and 72 hours

    11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"

  2. Total fentanyl consumption

    Time frame: From the end of surgery to 24, 48, and 72 hours postoperatively

    postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

  3. Postoperative nausea and vomiting

    Time frame: From the end of surgery to 24, 48, and 72 hours postoperatively

    Incidence of postoperative nausea and vomiting (%)

  4. Postoperative gastrointestinal dysfunction

    Time frame: postoperative 24, 48, and 72 hours

    I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction)

  5. Recovery time

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 14, 2022
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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