Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-70
SponsorWonju Severance Christian Hospital
About this trial
The goal of this clinical trial is to evaluate the effect of an Enhanced Recovery After Surgery(ERAS) protocol in patients undergoing gynecologic laparoscopic surgery under general anesthesia. The main question it aims to answer is: Does the ERAS protocol improve the quality of recovery compared to standard treatments?
Researchers will compare ERAS protocol with standard treatment to see if ERAS protocol improves the quality of recovery after surgery.
Participants will:
* Receive ERAS protocol during the hospitalization * Undergo bio-signal monitoring for one month using Hi-Cardi Plus device and Galaxy Watch 7 * Visit the hospital at one week and one month after discharge * Complete questionnaires(QOR-15K, WHO-DAS 2.0, EQ-5D-3L) at 24 hours after surgery, at discharge, one week after discharge, and one month after discharge
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 20 and 70 years
Scheduled to undergo gynecologic laparoscopic surgery under general anesthesia
Use of an Android smartphone
Disqualifiers
American Society of Anesthesiologists(ASA) physical status classification IV or higher
Body Mass Index (BMI) 35 or higher
Presence of diabetic autonomic neuropathy
History of esophageal hiatal hernia or delayed stomach discharge
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Recovery After Surgery
Procedure/Surgery1. Before surgery * Sips of water until 6 AM on the day of surgery, followed by a 200 mL carbohydrate drink * Pre-emptive oral analgesics (celecoxib 200mg 1 cap + acetaminophen 650mg 2 tab) 2. During surgery * Total intravenous anesthesia * Local anesthetic infiltration at the laparoscopic port site for post-operative pain control 3. After surgery * Sips of water and a foley catheter removal on ward arrival * Soft meal 4 housr after surgery * General diet 8 hours after surgery
Usual Care
Procedure/Surgery1. Before surgery * Midnight NPO * No pre-emptive analgesics 2. During surgery * Balanced anesthesia 3. After surgery * Sips of water 8 hours after arrival in the ward * Foley catheter removal one day after the surgery * Soft meal after gas out * General diet after one soft meal
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: ERASExperimental treatment 1 intervention
Group B: ConventionalActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of Recovey-15, Korean version (QoR-15K)
This patient-reported outcome measure consists of 15 items. Each item is rated on an 11-point Likert scale (0-10), yielding a total score ranging from 0 (very poor recovery) to 150 (excellent recovery). Higher scores indicate a better postoperative recovery.
Time frame
on 24 hours postoperatively2
Quality of Recovey-15, Korean version (QoR-15K)
This patient-reported outcome measure consists of 15 items. Each item is rated on an 11-point Likert scale (0-10), yielding a total score ranging from 0 (very poor recovery) to 150 (excellent recovery). Higher scores indicate a better postoperative recovery.
Time frame
one week after hospital discharge3
Quality of Recovey-15, Korean version (QoR-15K)
This patient-reported outcome measure consists of 15 items. Each item is rated on an 11-point Likert scale (0-10), yielding a total score ranging from 0 (very poor recovery) to 150 (excellent recovery). Higher scores indicate a better postoperative recovery.
Time frame
one month after hospital discharge4
The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0)
WHODAS 2.0 questionnaire consists of 36 items rated on a 5-point Likert scale (1-5), yielding a total score ranging from 36 to 180. Higher scores represent greater disability and poorer functioning.
Time frame
on 24 hours postoperativelySecondary outcomes
1
Pain (Visual analogue scale)
The Visual Analogue Scale (VAS) for pain ranges from 0 to 100, where 0 represents no pain and 100 represents the worst imaginable pain. Higher scores indicate more severe pain.
Time frame
on 24 hours postoperatively2
Pain (Visual analogue scale)
The Visual Analogue Scale (VAS) for pain ranges from 0 to 100, where 0 represents no pain and 100 represents the worst imaginable pain. Higher scores indicate more severe pain.
Time frame
1 week after hospital discharge3
Pain (Visual analogue scale)
The Visual Analogue Scale (VAS) for pain ranges from 0 to 100, where 0 represents no pain and 100 represents the worst imaginable pain. Higher scores indicate more severe pain.
Time frame
1 month after hospital discharge4
Length of stay
Time frame
throughout hospitalization, expected to be 2-3 daysOther outcomes
1
Heart rate variability
measured from wearable electrocardiography and a smart watch
Time frame
From discharge day to one month after dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wonju Severance Christian Hospital
Lead sponsor
Ministry of Trade, Industry & Energy, Republic of Korea
Collaborator
Source ClinicalTrials.gov
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