Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS Based on the Mobile Application

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 hours 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 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 or robotic surgery under general anesthesia. The main question it aims to answer is: Does the ERAS protocol improve the quality of recovery compared with a historical control group?

Researchers will compare the prospective ERAS group with a historical control group using data from previously completed studies to evaluate whether the ERAS protocol improves the quality of recovery after surgery.

Participants in the prospective ERAS group will:

* Receive the ERAS protocol during the perioperative period
* Undergo post-discharge bio-signal monitoring using HiCardi Plus and either Galaxy Watch 7 or Apple Watch 11
* Use the ONDA mobile application for health content and electronic questionnaires
* Complete questionnaires (QoR-15K, WHO-DAS short form, and EQ-5D-5L) before

surgery, 24 hours after surgery, one week after discharge, and one month after discharge

Eligibility

Primary outcome measure(s)

• Quality of Recovery-15, Korean version (QoR-15K) — 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 Recovery-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 Recovery-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, Short Form (WHO-DAS) — 24 hours postoperatively
  The 12-item self-administered version of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) assesses disability and functioning over the previous 30 days. Each item is rated on a 5-point scale, with higher scores indicating greater disability and poorer functioning.
• The World Health Organization Disability Assessment Schedule, Short Form (WHO-DAS) — one week after hospital discharge
  The 12-item self-administered version of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) assesses disability and functioning over the previous 30 days. Each item is rated on a 5-point scale, with higher scores indicating greater disability and poorer functioning.
• The World Health Organization Disability Assessment Schedule, Short Form (WHO-DAS) — one month after hospital discharge
  The 12-item self-administered version of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) assesses disability and functioning over the previous 30 days. Each item is rated on a 5-point scale, with higher scores indicating greater disability and poorer functioning.
• EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) — 24 hours postoperatively
  The EQ-5D-5L 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 5-level scale, where higher levels indicate more severe problems. The questionnaire also includes the EQ visual analogue scale (EQ VAS) for self-rated health.
• EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) — one week after hospital discharge
  The EQ-5D-5L 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 5-level scale, where higher levels indicate more severe problems. The questionnaire also includes the EQ visual analogue scale (EQ VAS) for self-rated health.
• EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) — one month after hospital discharge
  The EQ-5D-5L 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 5-level scale, where higher levels indicate more severe problems. The questionnaire also includes the EQ visual analogue scale (EQ VAS) for self-rated health.

Trial sites (1)

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