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| Name | Class |
|---|---|
| Ministry of Trade, Industry & Energy, Republic of Korea | OTHER_GOV |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS | Experimental |
| |
| Conventional | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Recovery After Surgery | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | one week after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | on 24 hours postoperatively |
| Pain (Visual analogue scale) |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | measured from wearable electrocardiography and a smart watch | From discharge day to one month after discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung Woo Song, M.D., Ph.D. | Contact | +82 033-741-1536 | yonfong@yonsei.ac.kr | |
| Hunju Lee, M.D., Ph.D. | Contact | +82 033-741-0341 | hjlee5371@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | 26426 | South Korea |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
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| Usual Care | Procedure |
|
|
| 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. | 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. | 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. | 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. | 1 month after hospital discharge |
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. |
| 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. | 1 month after hospital discharge |
| Length of stay | throughout hospitalization, expected to be 2-3 days |
| Total in-hospital opioid consumption | opioid consumption to alleviate pain; exclude intraoperative remifentanil | throughout hospitalization, expected to be 2-3 days |
| Complication | 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 | From enrollment to one month after discharge |