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

W

Wonju Severance Christian Hospital

Status

Not yet enrolling

Conditions

General Anesthesia
Gynecologic Surgery

Treatments

Procedure: Enhanced Recovery After Surgery
Procedure: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT07146178
ERAS2025

Details and patient eligibility

About

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

Enrollment

200 estimated patients

Sex

Female

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

ERAS
Experimental group
Treatment:
Procedure: Enhanced Recovery After Surgery
Conventional
Active Comparator group
Treatment:
Procedure: Usual Care

Trial contacts and locations

1

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Central trial contact

Hunju Lee, M.D., Ph.D.; Seung Woo Song, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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