ERAS on Postoperative Recovery After Laparoscopic Distal Gastrectomy

Seoul National University

Status

Completed

Conditions

Enhanced Recovery After Surgery

Treatments

Procedure: ERAS protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT05649319

2207-206-1346

Details and patient eligibility

About

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.

Full 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.

Enrollment

98 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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