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Not yet recruiting NCT07146178

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

No phase Interventional Gynecologic Surgery General Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced Recovery After Surgery, Usual Care.
Who it may be relevant to
Registry conditions: Gynecologic Surgery, General Anesthesia. Basic parameters: 20 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Procedure Enhanced 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 housr after surgery * General diet 8 hours after su
  • Procedure Usual 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 the surgery * Soft meal after gas out * General diet after one soft meal

Primary outcome measures

  • Quality of Recovey-15, Korean version (QoR-15K) [Time frame: on 24 hours postoperatively]
  • Quality of Recovey-15, Korean version (QoR-15K) [Time frame: one week after hospital discharge]
  • Quality of Recovey-15, Korean version (QoR-15K) [Time frame: one month after hospital discharge]
  • The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0) [Time frame: on 24 hours postoperatively]
  • The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0) [Time frame: one week after hospital discharge]
  • The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0) [Time frame: one month after hospital discharge]
  • EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L) [Time frame: on 24 hours postoperatively]
  • EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L) [Time frame: 1 week after hospital discharge]
  • EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L) [Time frame: 1 month after hospital discharge]
Secondary outcome measures (7)
  • Pain (Visual analogue scale) [Time frame: on 24 hours postoperatively]
  • Pain (Visual analogue scale) [Time frame: 1 week after hospital discharge]
  • Pain (Visual analogue scale) [Time frame: 1 month after hospital discharge]
  • Length of stay [Time frame: throughout hospitalization, expected to be 2-3 days]
  • Total in-hospital opioid consumption [Time frame: throughout hospitalization, expected to be 2-3 days]
  • Complication [Time frame: From enrollment to one month after discharge]
  • Readmission [Time frame: From enrollment to one month after discharge]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Wonju Severance Christian Hospital — Wŏnju

Identifiers

NCT: NCT07146178 · ERAS2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗