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

NCT ID: NCT07146178

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-10-01

Brief Summary

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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

Detailed Description

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Conditions

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Gynecologic Surgery General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ERAS

Group Type EXPERIMENTAL

Enhanced Recovery After Surgery

Intervention Type PROCEDURE

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

Conventional

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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ERAS

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Trade, Industry & Energy, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Wonju Severance Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Song Seung Woo

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status

Countries

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South Korea

Central Contacts

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Seung Woo Song, M.D., Ph.D.

Role: CONTACT

+82 033-741-1536

Hunju Lee, M.D., Ph.D.

Role: CONTACT

+82 033-741-0341

Facility Contacts

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Seung Woo Song, M.D., Ph.D.

Role: primary

+82 033-741-1536

Hunju Lee, M.D., Ph.D.

Role: backup

+82 033-741-0341

Other Identifiers

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ERAS2025

Identifier Type: -

Identifier Source: org_study_id

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