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NCT Number: NCT07146178

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

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

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Key information

Conditions

Gynecologic Surgery General Anesthesia

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Enhanced recovery after surgery

Procedure
  • 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)
  • During surgery
  • Total intravenous anesthesia
  • Local anesthetic infiltration at the laparoscopic port site for post-operative pain control
  • 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

Other names: ERAS

usual care

Procedure
  • Before surgery
  • Midnight NPO
  • No pre-emptive analgesics
  • During surgery
  • Balanced anesthesia
  • 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

Primary outcomes

  1. Quality of Recovey-15, Korean version (QoR-15K)

    Time frame: 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.

  2. Quality of Recovey-15, Korean version (QoR-15K)

    Time frame: 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.

  3. Quality of Recovey-15, Korean version (QoR-15K)

    Time frame: 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.

  4. The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0)

    Time frame: 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.

  5. The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0)

    Time frame: 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.

  6. The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0)

    Time frame: 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.

  7. EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L)

    Time frame: 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.

  8. EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L)

    Time frame: 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.

  9. EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L)

    Time frame: 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.

Secondary outcomes

  1. Pain (Visual analogue scale)

    Time frame: 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.

  2. Pain (Visual analogue scale)

    Time frame: 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.

  3. Pain (Visual analogue scale)

    Time frame: 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.

  4. Length of stay

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

  5. Total in-hospital opioid consumption

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

    opioid consumption to alleviate pain; exclude intraoperative remifentanil

  6. Complication

    Time frame: From enrollment to one month after discharge

  7. Readmission

    Time frame: 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

  1. Heart rate variability

    Time frame: From discharge day to one month after discharge

    measured from wearable electrocardiography and a smart watch

Study contacts

Contact information is provided by the study sponsor or research team.

Hunju Lee, M.D., Ph.D.

CONTACT

[email protected]

+82 033-741-0341

Seung Woo Song, M.D., Ph.D.

CONTACT

[email protected]

+82 033-741-1536

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Collaborators

  • Ministry of Trade, Industry & Energy, Republic of Korea

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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