ClinicalTrials.gg
Enrolling by invitationNCT07868952Updated Oct 23, 2026

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

An interventional study of Enhanced Recovery After Surgery and Usual Care in Gynecologic Surgery and General Anesthesia, sponsored by Wonju Severance Christian Hospital. Enrolling by invitation at 1 site in South Korea. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Wonju Severance Christian Hospital · Not applicable, Interventional, and Treatment

Updated Oct 23, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
350
Allocation
Non-randomized
Ages
20 Years to 70 Years
Sex
Female
01

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

02

Conditions studied

  • Gynecologic Surgery
  • General Anesthesia

Keywords

  • Enhanced Recovery After Surgery
  • Wearable Devices
  • Bio-signal Monitoring
  • Mobile Application
03

In context

Lead sponsor

Wonju Severance Christian Hospital is the lead sponsor of 43 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
350 participants (estimated)

Study arms

  • Experimental
    ERAS Intervention Group

    Procedure: Enhanced Recovery After Surgery

  • Active comparator
    Historical Control Group

    Procedure: Usual Care

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 hours after surgery * General diet 8 hours after surgery

    Also known as: ERAS

  • 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 surgery * Soft meal after gas out * General diet after one soft meal

06

What researchers measure

Primary outcomes

  1. Quality of Recovery-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: 24 hours postoperatively

  2. Quality of Recovery-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 discharge

  3. Quality of Recovery-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 discharge

  4. The World Health Organization Disability Assessment Schedule, Short Form (WHO-DAS)

    The 12-item self-administered World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) assesses difficulties in functioning over the preceding 30 days. Each item is scored from 1 (no difficulty) to 5 (extreme difficulty or cannot do). The 12 item scores are summed to yield a total score ranging from 12 to 60, with higher scores indicating greater disability and poorer functioning.

    Time frame: 24 hours postoperatively

  5. The World Health Organization Disability Assessment Schedule, Short Form (WHO-DAS)

    The 12-item self-administered World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) assesses difficulties in functioning over the preceding 30 days. Each item is scored from 1 (no difficulty) to 5 (extreme difficulty or cannot do). The 12 item scores are summed to yield a total score ranging from 12 to 60, with higher scores indicating greater disability and poorer functioning.

    Time frame: one week after hospital discharge

  6. The World Health Organization Disability Assessment Schedule, Short Form (WHO-DAS)

    The 12-item self-administered World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) assesses difficulties in functioning over the preceding 30 days. Each item is scored from 1 (no difficulty) to 5 (extreme difficulty or cannot do). The 12 item scores are summed to yield a total score ranging from 12 to 60, with higher scores indicating greater disability and poorer functioning.

    Time frame: one month after hospital discharge

  7. EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

    The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is coded from 1 (no problems) to 5 (extreme problems or inability to perform the activity), with higher levels indicating more severe problems. The questionnaire also includes the EQ visual analogue scale (EQ VAS) for self-rated health. The EQ VAS ranges from 0 (the worst health imaginable) to 100 (the best health imaginable), with higher scores indicating better perceived health.

    Time frame: 24 hours postoperatively

  8. EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

    The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is coded from 1 (no problems) to 5 (extreme problems or inability to perform the activity), with higher levels indicating more severe problems. The questionnaire also includes the EQ visual analogue scale (EQ VAS) for self-rated health. The EQ VAS ranges from 0 (the worst health imaginable) to 100 (the best health imaginable), with higher scores indicating better perceived health.

    Time frame: one week after hospital discharge

  9. EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

    The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is coded from 1 (no problems) to 5 (extreme problems or inability to perform the activity), with higher levels indicating more severe problems. The questionnaire also includes the EQ visual analogue scale (EQ VAS) for self-rated health. The EQ VAS ranges from 0 (the worst health imaginable) to 100 (the best health imaginable), with higher scores indicating better perceived health.

    Time frame: one month after hospital discharge

Secondary 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: 24 hours postoperatively

  2. 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 discharge

  3. 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 discharge

  4. Length of stay

    Time frame: throughout hospitalization, expected to be 2-3 days

  5. Total in-hospital opioid consumption

    opioid consumption to alleviate pain; exclude intraoperative remifentanil

    Time frame: throughout hospitalization, expected to be 2-3 days

  6. Complication

    Time frame: From enrollment to one month after discharge

  7. Readmission

    All-cause hospital readmission within 30 days after discharge, defined as any unplanned inpatient admission to any hospital

    Time frame: From enrollment to one month after discharge

Other outcomes

  1. Heart rate variability

    measured from wearable electrocardiography and a smart watch

    Time frame: From discharge day to one month after discharge

07

Study locations

1 site
  • Wonju Severance Christian Hospital
    Wŏnju, Gangwon-do 26426, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Also revised
primary outcomes
Registered
First appeared on the registry
Oct 9, 2026
Show all 2 updates
  1. Oct 23, 2026
    Primary outcomes Revised (6 changes)
  2. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07868952
Lead sponsor
Wonju Severance Christian Hospital
Collaborators
Ministry of Trade, Industry & Energy, Republic of Korea
Responsible party
Hunju Lee (assistant professor, Wonju Severance Christian Hospital) — Principal investigator
First posted
Oct 9, 2026
Start date
Sep 28, 2026 (estimated)
Primary completion
Aug 27, 2027 (estimated)
Completion
Aug 27, 2027 (estimated)
Last update
Oct 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion