General Anesthesia, Gynecologic Surgery
Conditions
Keywords
Enhanced recovery after surgery, bio-signal monitoring
Brief summary
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
Interventions
PROCEDUREEnhanced Recovery After Surgery
1. 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
PROCEDUREUsual Care
1. 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
Sponsors
Ministry of Trade, Industry & Energy, Republic of Korea
Wonju Severance Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age between 20 and 70 years * Scheduled to undergo gynecologic laparoscopic surgery under general anesthesia * Use of an Android smartphone
Exclusion criteria
* 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 * Known allergy to local anesthesia * Participantion in other trials that may affect study outcomes * Inability to complete questionnaires (e.g., due to cognitive impairment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L) | on 24 hours postoperatively | EQ-5D-3L questionnaire assesses health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 3-level scale (1 = no problems, 2 = some problems, 3 = extreme problems), where higher scores within each domain indicate worse health status. |
| Quality of Recovey-15, Korean version (QoR-15K) | on 24 hours postoperatively | 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. |
| The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0) | on 24 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total in-hospital opioid consumption | throughout hospitalization, expected to be 2-3 days | opioid consumption to alleviate pain; exclude intraoperative remifentanil |
| Readmission | From enrollment to one month after discharge | All-cause hospital readmission within 30 days after discharge, defined as any unplanned inpatient admission to any hospital |
| Complication | From enrollment to one month after discharge | — |
| Pain (Visual analogue scale) | on 24 hours postoperatively | 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. |
| Length of stay | throughout hospitalization, expected to be 2-3 days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability | From discharge day to one month after discharge | measured from wearable electrocardiography and a smart watch |
Countries
South Korea
Contacts
Primary ContactSeung Woo Song, M.D., Ph.D.
Backup ContactHunju Lee, M.D., Ph.D.
Outcome results
None listed