Clinical trial NCT05649319: ERAS on Postoperative Recovery After Laparoscopic Distal Gastrectomy
Official title: Effectiveness of Enhanced Recovery After Surgery (ERAS) on Postoperative Recovery After Laparoscopic Distal Gastrectomy: An Open-labeled Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enhanced Recovery After Surgery
Keywords: Enhanced Recovery After Surgery
Stomach Neoplasms
Gastrectomy
Pain, Postoperative
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 98
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized open-labeled study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of the Quality of recovery-15 during the first 72 hours after surgery
timeFrame: postoperative 24, 48, and 72 hours
Secondary outcomes:
measure: Postoperative pain score
timeFrame: postoperative 24, 48, and 72 hours
measure: Total fentanyl consumption
timeFrame: From the end of surgery to 24, 48, and 72 hours postoperatively
measure: Postoperative nausea and vomiting
timeFrame: From the end of surgery to 24, 48, and 72 hours postoperatively
measure: Postoperative gastrointestinal dysfunction
timeFrame: postoperative 24, 48, and 72 hours
measure: Recovery time
timeFrame: Evaluate every hour starting from 9A on the postoperative day 3 up to discharge
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Do Joong Park, MD, PhD
role: STUDY_DIRECTOR
References: