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

NCT07868952 — Not applicable, Enrolling by invitation, 350 participants, Wonju Severance Christian Hospital

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Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of an Application-based Enhanced Recovery After Surgery (ERAS) Program

RegistryNCT07868952
StatusEnrolling by invitation
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment350 (Estimated)
SponsorWonju Severance Christian Hospital (Other); collaborators: Ministry of Trade, Industry & Energy, Republic of Korea
ConditionsGynecologic Surgery, General Anesthesia
InterventionsEnhanced Recovery After Surgery, Usual Care (Procedure)
Datesstart 2026-09-28 (estimated), primary completion 2027-08-27 (estimated), completion 2027-08-27 (estimated), first posted 2026-10-09, last updated 2026-10-16
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Gynecologic Surgery All trials for General Anesthesia All trials of Enhanced Recovery After Surgery All trials of Usual Care

-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

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+Arms and interventions

ArmTypeInterventionsDescription
ERAS Intervention GroupExperimentalProcedure: Enhanced Recovery After Surgery
Historical Control GroupActive comparatorProcedure: Usual Care
  • Enhanced Recovery After Surgery (Procedure), also known as ERAS: 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 (Procedure): 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

+Outcome measures

Primary outcomes

  • 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.

Secondary outcomes

  • Pain (Visual analogue scale) [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.
  • Pain (Visual analogue scale) [1 week after hospital discharge]: 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.
  • Pain (Visual analogue scale) [1 month after hospital discharge]: 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]
  • Total in-hospital opioid consumption [throughout hospitalization, expected to be 2-3 days]: opioid consumption to alleviate pain; exclude intraoperative remifentanil
  • Complication [From enrollment to one month after discharge]
  • 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

Other outcomes

  • Heart rate variability [From discharge day to one month after discharge]: measured from wearable electrocardiography and a smart watch

+Eligibility

Sex: Female, ages: 20 Years to 70 Years

Inclusion Criteria:

* Age between 20 and 70 years
* Scheduled to undergo gynecologic laparoscopic or robotic surgery under general anesthesia

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
* Participation in other trials that may affect study outcomes
* Inability to complete questionnaires (e.g., due to cognitive impairment)

+Locations (1)

FacilityCityCountryStatus
Wonju Severance Christian HospitalWŏnju, Gangwon-doSouth Korea