ERAS on Postoperative Recovery After Laparoscopic Distal Gastrectomy

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05649319

Collaborator

(none)

Enrollment

Location

Arms

27.5

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Enhanced Recovery After Surgery	Procedure: ERAS protocol	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A prospective randomized open-labeled studyA prospective randomized open-labeled study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Dec 14, 2024

Anticipated Study Completion Date :

Mar 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ERAS group Perioperative care for laparoscopic distal gastrectomy is managed according to ERAS protocol.	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.
No Intervention: Conventional group Perioperative care for laparoscopic distal gastrectomy is managed according to our current perioperative practice.

Arm

Intervention/Treatment

Experimental: ERAS group

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

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.

No Intervention: Conventional group

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

Outcome Measures

Primary Outcome Measures

Change of the Quality of recovery-15 during the first 72 hours after surgery [postoperative 24, 48, and 72 hours]
Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	KS013

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Study Director: Do Joong Park, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hojin Lee, MD, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT05649319

Other Study ID Numbers:

2207-206-1346

First Posted:

Dec 14, 2022

Last Update Posted:

Dec 14, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hojin Lee, MD, Professor, Seoul National University Hospital

Enhanced Recovery After Surgery

Stomach Neoplasms

Gastrectomy

Pain, Postoperative

Study Results

No Results Posted as of Dec 14, 2022