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
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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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-09-01
2026-10-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ERAS
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
Conventional
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo gynecologic laparoscopic surgery under general anesthesia
* Use of an Android smartphone
Exclusion Criteria
* 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)
20 Years
70 Years
FEMALE
No
Sponsors
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Ministry of Trade, Industry & Energy, Republic of Korea
OTHER_GOV
Wonju Severance Christian Hospital
OTHER
Responsible Party
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Song Seung Woo
Assistant professor
Locations
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Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ERAS2025
Identifier Type: -
Identifier Source: org_study_id
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