Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS

Condition(s) studied

Investigational drug(s) / intervention(s)

Enhanced 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

Usual 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

Study 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

Eligibility

Primary outcome measure(s)

• 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.
• Quality of Recovey-15, Korean version (QoR-15K) — one week after hospital discharge
  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.
• Quality of Recovey-15, Korean version (QoR-15K) — one month after hospital discharge
  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.
• The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0) — one week after hospital discharge
  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.
• The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0) — one month after hospital discharge
  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.
• 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.
• EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L) — 1 week after hospital discharge
  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.
• EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L) — 1 month after hospital discharge
  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.

Trial sites (1)

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