Gynecologic SurgeryNCT07868952
Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS Based on the Mobile Application
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 or robotic 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
- 350 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2026to 27 Aug 2027
- Phase
- Interventional
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 or robotic surgery under general anesthesia
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
- Participation 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
About this study
Official title: Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of an Application-based 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 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.
Read more
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
- Conditions
- Gynecologic Surgery, General Anesthesia
- Being tested
- Enhanced Recovery After Surgery, Usual Care
- Keywords
- Enhanced Recovery After Surgery, Wearable Devices, Bio-signal Monitoring, Mobile Application
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 hours 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 surgery
- Soft meal after gas out
- General diet after one soft meal
| Study group | Role | What they receive |
|---|---|---|
| ERAS Intervention Group | Experimental | Not described Receives: Procedure: Enhanced Recovery After Surgery |
| Historical Control Group | 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 Recovery-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: 24 hours postoperatively
Quality of Recovery-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 Recovery-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, Short Form (WHO-DAS)
The 12-item self-administered World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) assesses difficulties in functioning over the preceding 30 days. Each item is scored from 1 (no difficulty) to 5 (extreme difficulty or cannot do). The 12 item scores are summed to yield a total score ranging from 12 to 60, with higher scores indicating greater disability and poorer functioning.
Measured: 24 hours postoperatively
The World Health Organization Disability Assessment Schedule, Short Form (WHO-DAS)
The 12-item self-administered World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) assesses difficulties in functioning over the preceding 30 days. Each item is scored from 1 (no difficulty) to 5 (extreme difficulty or cannot do). The 12 item scores are summed to yield a total score ranging from 12 to 60, with higher scores indicating greater disability and poorer functioning.
Measured: one week after hospital discharge
The World Health Organization Disability Assessment Schedule, Short Form (WHO-DAS)
The 12-item self-administered World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) assesses difficulties in functioning over the preceding 30 days. Each item is scored from 1 (no difficulty) to 5 (extreme difficulty or cannot do). The 12 item scores are summed to yield a total score ranging from 12 to 60, with higher scores indicating greater disability and poorer functioning.
Measured: one month after hospital discharge
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is coded from 1 (no problems) to 5 (extreme problems or inability to perform the activity), with higher levels indicating more severe problems. The questionnaire also includes the EQ visual analogue scale (EQ VAS) for self-rated health. The EQ VAS ranges from 0 (the worst health imaginable) to 100 (the best health imaginable), with higher scores indicating better perceived health.
Measured: 24 hours postoperatively
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is coded from 1 (no problems) to 5 (extreme problems or inability to perform the activity), with higher levels indicating more severe problems. The questionnaire also includes the EQ visual analogue scale (EQ VAS) for self-rated health. The EQ VAS ranges from 0 (the worst health imaginable) to 100 (the best health imaginable), with higher scores indicating better perceived health.
Measured: one week after hospital discharge
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is coded from 1 (no problems) to 5 (extreme problems or inability to perform the activity), with higher levels indicating more severe problems. The questionnaire also includes the EQ visual analogue scale (EQ VAS) for self-rated health. The EQ VAS ranges from 0 (the worst health imaginable) to 100 (the best health imaginable), with higher scores indicating better perceived health.
Measured: one 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: 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 posted9 Oct 2026
- Study start28 Sep 2026 (estimated)
- Primary completion27 Aug 2027 (estimated)
- Study completion27 Aug 2027 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 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, Hunju Lee, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868952
- Sponsor's protocol ID
- ERAS2026
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No