ERAS on Postoperative Recovery After Laparoscopic Distal Gastrectomy

Enhanced Recovery After Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05649319
• Other study ID #: 2207-206-1346
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: March 30, 2025

Study information

• Verified date: December 2022
• Source: Seoul National University Hospital
• Contact: Hojin Lee, MD, PhD
• Phone: 82-2-2072-2467
• Email: zenerdiode03[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: March 30, 2025
• Est. primary completion date: December 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative pain score	11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"	postoperative 24, 48, and 72 hours
Secondary	Total fentanyl consumption	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia	postoperative 24, 48, and 72 hours
Secondary	Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting (%)	postoperative 24, 48, and 72 hours
Secondary	Postoperative gastrointestinal dysfunction	I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction)	postoperative 24, 48, and 72 hours