ERAS on Postoperative Recovery After Laparoscopic Distal Gastrectomy

NCT05649319 | Completed

• 1 other identifier: 2207-206-1346
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Enhanced Recovery After Surgery

Keywords

Enhanced Recovery After Surgery; Stomach Neoplasms; Gastrectomy; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative pain score

  postoperative 24, 48, and 72 hours

• Total fentanyl consumption

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

• Postoperative nausea and vomiting

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

• Postoperative gastrointestinal dysfunction

  postoperative 24, 48, and 72 hours

• Recovery time

  Evaluate every hour starting from 9A on the postoperative day 3 up to discharge

Study Arms (2)

ERAS group

EXPERIMENTAL

Perioperative care for laparoscopic distal gastrectomy is managed according to ERAS protocol.

Procedure: ERAS protocol

Conventional group

NO INTERVENTION

Perioperative care for laparoscopic distal gastrectomy is managed according to our current perioperative practice.

Interventions

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.

ERAS group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, KS013, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Do Joong Park, MD, PhD

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective randomized open-labeled study

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 14, 2022
• Study Start: February 3, 2023
• Primary Completion: June 7, 2024
• Study Completion: August 30, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

KR (1)