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

NCT07146178 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-08-28

No results posted yet for this 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 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

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 surgery

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

Sponsors & Collaborators

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

    collaborator OTHER_GOV

  • Wonju Severance Christian Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-10-01
Completion
2026-10-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146178 on ClinicalTrials.gov