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Enrolling By Invitation
NCT07868952
Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS Based on the Mobile Application
Conditions: Gynecologic Surgery, General Anesthesia
Sex: Female
Ages: 20 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 350
Sponsor: Wonju Severance Christian Hospital
Location: Wonju Severance Christian Hospital Wŏnju Gangwon-do
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
Eligibility Criteria
Inclusion Criteria:
* Age between 20 and 70 years
* Scheduled to undergo gynecologic laparoscopic or robotic surgery under general anesthesia
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
* Participation in other trials that may affect study outcomes
* Inability to complete questionnaires (e.g., due to cognitive impairment)
Source: ClinicalTrials.gov (NCT07868952). StuddyBuddy aggregates publicly available trial information.