Gynecologic SurgeryNCT07146178
Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS
A study testing Enhanced Recovery After Surgery in people with Gynecologic Surgery and General Anesthesia, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Gynecologic Surgery, General Anesthesia
- What is being tested?
- Enhanced Recovery After Surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 70 years
- Scheduled to undergo gynecologic laparoscopic surgery under general anesthesia
- Use of an Android smartphone
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Seung Woo Song, M.D., Ph.D., +82 033-741-1536, yonfong@yonsei.ac.kr
Hunju Lee, M.D., Ph.D., +82 033-741-0341, hjlee5371@gmail.com
About this study
Official title: Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of Enhanced Recovery After Surgery(ERAS) Program
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.
Read more
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
- Being tested
- Enhanced Recovery After Surgery, Usual Care
- Keywords
- Enhanced recovery after surgery, bio-signal monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After SurgeryProcedure or surgery
Also called ERAS
- 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)
- During surgery
- Total intravenous anesthesia
- Local anesthetic infiltration at the laparoscopic port site for post-operative pain control
- 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 CareProcedure or surgery
- Before surgery
- Midnight NPO
- No pre-emptive analgesics
- During surgery
- Balanced anesthesia
- 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
| Study group | Role | What they receive |
|---|---|---|
| ERAS | Experimental | Not described Receives: Procedure: Enhanced Recovery After Surgery |
| Conventional | Active comparator | Not described Receives: Procedure: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovey-15, Korean version (QoR-15K)
This patient-reported outcome measure consists of 15 items. Each item is rated on an 11-point Likert scale (0-10), yielding a total score ranging from 0 (very poor recovery) to 150 (excellent recovery). Higher scores indicate a better postoperative recovery.
Measured: on 24 hours postoperatively
Quality of Recovey-15, Korean version (QoR-15K)
This patient-reported outcome measure consists of 15 items. Each item is rated on an 11-point Likert scale (0-10), yielding a total score ranging from 0 (very poor recovery) to 150 (excellent recovery). Higher scores indicate a better postoperative recovery.
Measured: one week after hospital discharge
Quality of Recovey-15, Korean version (QoR-15K)
This patient-reported outcome measure consists of 15 items. Each item is rated on an 11-point Likert scale (0-10), yielding a total score ranging from 0 (very poor recovery) to 150 (excellent recovery). Higher scores indicate a better postoperative recovery.
Measured: one month after hospital discharge
The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0)
WHODAS 2.0 questionnaire consists of 36 items rated on a 5-point Likert scale (1-5), yielding a total score ranging from 36 to 180. Higher scores represent greater disability and poorer functioning.
Measured: on 24 hours postoperatively
The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0)
WHODAS 2.0 questionnaire consists of 36 items rated on a 5-point Likert scale (1-5), yielding a total score ranging from 36 to 180. Higher scores represent greater disability and poorer functioning.
Measured: one week after hospital discharge
The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0)
WHODAS 2.0 questionnaire consists of 36 items rated on a 5-point Likert scale (1-5), yielding a total score ranging from 36 to 180. Higher scores represent greater disability and poorer functioning.
Measured: one month after hospital discharge
EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L)
EQ-5D-3L questionnaire assesses health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 3-level scale (1 = no problems, 2 = some problems, 3 = extreme problems), where higher scores within each domain indicate worse health status.
Measured: on 24 hours postoperatively
EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L)
EQ-5D-3L questionnaire assesses health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 3-level scale (1 = no problems, 2 = some problems, 3 = extreme problems), where higher scores within each domain indicate worse health status.
Measured: 1 week after hospital discharge
EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L)
EQ-5D-3L questionnaire assesses health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 3-level scale (1 = no problems, 2 = some problems, 3 = extreme problems), where higher scores within each domain indicate worse health status.
Measured: 1 month after hospital discharge
Secondary outcomes (7)
Pain (Visual analogue scale)
The Visual Analogue Scale (VAS) for pain ranges from 0 to 100, where 0 represents no pain and 100 represents the worst imaginable pain. Higher scores indicate more severe pain.
Measured: on 24 hours postoperatively
Pain (Visual analogue scale)
The Visual Analogue Scale (VAS) for pain ranges from 0 to 100, where 0 represents no pain and 100 represents the worst imaginable pain. Higher scores indicate more severe pain.
Measured: 1 week after hospital discharge
Pain (Visual analogue scale)
The Visual Analogue Scale (VAS) for pain ranges from 0 to 100, where 0 represents no pain and 100 represents the worst imaginable pain. Higher scores indicate more severe pain.
Measured: 1 month after hospital discharge
Length of stay
Measured: throughout hospitalization, expected to be 2-3 days
Total in-hospital opioid consumption
opioid consumption to alleviate pain; exclude intraoperative remifentanil
Measured: throughout hospitalization, expected to be 2-3 days
Complication
Measured: From enrollment to one month after discharge
Readmission
All-cause hospital readmission within 30 days after discharge, defined as any unplanned inpatient admission to any hospital
Measured: From enrollment to one month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea
- Responsible party
- Principal investigator, Song Seung Woo, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146178
- Sponsor's protocol ID
- ERAS2025
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of Enhanced Recovery After Surgery(ERAS) Program
- ClinicalTrials.gov ID
- NCT07146178
- Acronym / sponsor ID
- ERAS2025
- Conditions
- Gynecologic Surgery, General Anesthesia
- Keywords
- Enhanced recovery after surgery, bio-signal monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS | Experimental | Procedure: Enhanced Recovery After Surgery |
| Conventional | Active comparator | Procedure: Usual Care |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20 and 70 years
- Scheduled to undergo gynecologic laparoscopic surgery under general anesthesia
- Use of an Android smartphone
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery After SurgeryAlso: ERAS1. 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 or surgery | ERAS |
| Usual Care1. 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 | Procedure or surgery | Conventional |
Primary outcome
Quality of Recovey-15, Korean version (QoR-15K)
Time frame: on 24 hours postoperatively
This patient-reported outcome measure consists of 15 items. Each item is rated on an 11-point Likert scale (0-10), yielding a total score ranging from 0 (very poor recovery) to 150 (excellent recovery). Higher scores indicate a better postoperative recovery.
Quality of Recovey-15, Korean version (QoR-15K)
Time frame: one week after hospital discharge
This patient-reported outcome measure consists of 15 items. Each item is rated on an 11-point Likert scale (0-10), yielding a total score ranging from 0 (very poor recovery) to 150 (excellent recovery). Higher scores indicate a better postoperative recovery.
Quality of Recovey-15, Korean version (QoR-15K)
Time frame: one month after hospital discharge
This patient-reported outcome measure consists of 15 items. Each item is rated on an 11-point Likert scale (0-10), yielding a total score ranging from 0 (very poor recovery) to 150 (excellent recovery). Higher scores indicate a better postoperative recovery.
The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0)
Time frame: on 24 hours postoperatively
WHODAS 2.0 questionnaire consists of 36 items rated on a 5-point Likert scale (1-5), yielding a total score ranging from 36 to 180. Higher scores represent greater disability and poorer functioning.
The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0)
Time frame: one week after hospital discharge
WHODAS 2.0 questionnaire consists of 36 items rated on a 5-point Likert scale (1-5), yielding a total score ranging from 36 to 180. Higher scores represent greater disability and poorer functioning.
The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0)
Time frame: one month after hospital discharge
WHODAS 2.0 questionnaire consists of 36 items rated on a 5-point Likert scale (1-5), yielding a total score ranging from 36 to 180. Higher scores represent greater disability and poorer functioning.
EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L)
Time frame: on 24 hours postoperatively
EQ-5D-3L questionnaire assesses health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 3-level scale (1 = no problems, 2 = some problems, 3 = extreme problems), where higher scores within each domain indicate worse health status.
EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L)
Time frame: 1 week after hospital discharge
EQ-5D-3L questionnaire assesses health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 3-level scale (1 = no problems, 2 = some problems, 3 = extreme problems), where higher scores within each domain indicate worse health status.
EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L)
Time frame: 1 month after hospital discharge
EQ-5D-3L questionnaire assesses health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 3-level scale (1 = no problems, 2 = some problems, 3 = extreme problems), where higher scores within each domain indicate worse health status.
7 secondary outcomes
Pain (Visual analogue scale)
Time frame: on 24 hours postoperatively
Pain (Visual analogue scale)
Time frame: 1 week after hospital discharge
Pain (Visual analogue scale)
Time frame: 1 month after hospital discharge
Length of stay
Time frame: throughout hospitalization, expected to be 2-3 days
Total in-hospital opioid consumption
Time frame: throughout hospitalization, expected to be 2-3 days
Complication
Time frame: From enrollment to one month after discharge
Readmission
Time frame: From enrollment to one month after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery in people with Gynecologic Surgery and General Anesthesia, run by Wonju Severance Christian Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seung Woo Song, M.D., Ph.D. (+82 033-741-1536, yonfong@yonsei.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovey-15, Korean version (QoR-15K) (time frame: on 24 hours postoperatively). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.