NCT07868952

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 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Aug 2027

Study Start

First participant enrolled

September 28, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

11 months

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Gynecologic SurgeryGeneral Anesthesia

Keywords

Enhanced Recovery After SurgeryWearable DevicesBio-signal MonitoringMobile Application

Outcome Measures

Primary Outcomes (9)

  • 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.

    24 hours postoperatively

  • 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.

    one week after hospital discharge

  • 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.

    one month after hospital discharge

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

    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.

    24 hours postoperatively

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

    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.

    one week after hospital discharge

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

    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.

    one month after hospital discharge

  • EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

    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.

    24 hours postoperatively

  • EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

    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.

    one week after hospital discharge

  • EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

    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.

    one month after hospital discharge

Secondary Outcomes (7)

  • Pain (Visual analogue scale)

    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

  • +2 more secondary outcomes

Other Outcomes (1)

  • Heart rate variability

    From discharge day to one month after discharge

Study Arms (2)

ERAS Intervention Group

EXPERIMENTAL
Procedure: Enhanced Recovery After Surgery

Historical Control Group

ACTIVE COMPARATOR
Procedure: Usual Care

Interventions

Enhanced Recovery After SurgeryPROCEDURE

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
ERAS Intervention Group
Usual CarePROCEDURE

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

Historical Control Group

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 CareSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start

September 28, 2026

Primary Completion (Estimated)

August 27, 2027

Study Completion (Estimated)

August 27, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)