ERAS on Postoperative Recovery After Laparoscopic Distal Gastrectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Enhanced Recovery After Surgery

Intervention / Treatment
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* Procedure: ERAS protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized open-labeled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS group<br>Perioperative care for laparoscopic distal gastrectomy is managed according to ERAS protocol. | Procedure: ERAS protocol<br>* 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.<br>|
| No Intervention: Conventional group<br>Perioperative care for laparoscopic distal gastrectomy is managed according to our current perioperative practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Total fentanyl consumption | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia | postoperative 24, 48, and 72 hours | 
| Postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting (%) | postoperative 24, 48, and 72 hours | 
| Postoperative gastrointestinal dysfunction | I-FEED score 3 points or more (postoperative gastrointestinal intolerance and dysfunction) | postoperative 24, 48, and 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enhanced Recovery After Surgery, Stomach Neoplasms, Gastrectomy, Pain, Postoperative