ERAS on Postoperative Recovery After Laparoscopic Distal Gastrectomy

NCT ID: NCT05649319

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2024-08-30

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.

Conditions

Enhanced Recovery After Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ERAS group

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

Group Type: EXPERIMENTAL

ERAS protocol

Intervention Type: 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.

Conventional group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hojin Lee, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Do Joong Park, MD, PhD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2207-206-1346

Identifier Type: -

Identifier Source: org_study_id