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

NCT07146178 | Not Yet Recruiting

• 1 other identifier: ERAS2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gynecologic Surgery; General Anesthesia

Keywords

Enhanced recovery after surgery; bio-signal monitoring

Outcome Measures

Primary Outcomes (9)

• Quality of Recovey-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.

  on 24 hours postoperatively

• Quality of Recovey-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.

  one week after hospital discharge

• Quality of Recovey-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.

  one month after hospital discharge

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

  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.

  on 24 hours postoperatively

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

  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.

  one week after hospital discharge

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

  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.

  one month after hospital discharge

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

  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.

  on 24 hours postoperatively

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

  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.

  1 week after hospital discharge

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

  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.

  1 month after hospital discharge

Secondary Outcomes (7)

• Pain (Visual analogue scale)

  on 24 hours postoperatively

• Pain (Visual analogue scale)

  1 week after hospital discharge

• Pain (Visual analogue scale)

  1 month after hospital discharge

• Length of stay

  throughout hospitalization, expected to be 2-3 days

• Total in-hospital opioid consumption

  throughout hospitalization, expected to be 2-3 days

Other Outcomes (1)

• Heart rate variability

  From discharge day to one month after discharge

Study Arms (2)

ERAS

EXPERIMENTAL

Procedure: Enhanced Recovery After Surgery

Conventional

ACTIVE COMPARATOR

Procedure: Usual Care

Interventions

Enhanced Recovery After Surgery PROCEDURE

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

Also known as: ERAS

ERAS

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

Conventional

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 and 70 years
• Scheduled to undergo gynecologic laparoscopic surgery under general anesthesia
• Use of an Android smartphone

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead
• Ministry of Trade, Industry & Energy, Republic of Korea: collaborator

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

MeSH Terms

Interventions

Enhanced Recovery After Surgery

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Central Study Contacts

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

CONTACT

+82 033-741-1536; yonfong@yonsei.ac.kr

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

CONTACT

+82 033-741-0341; hjlee5371@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 28, 2025
• Study Start: September 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)