Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of Enhanced Recovery After Surgery(ERAS) Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Quality of Recovey-15, Korean version (QoR-15K)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 70 years
- •Scheduled to undergo gynecologic laparoscopic surgery under general anesthesia
- •Use of an Android smartphone
排除标准
- •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)
研究组 & 干预措施
ERAS
干预措施: Enhanced Recovery After Surgery (Procedure)
Conventional
干预措施: Usual Care (Procedure)
结局指标
主要结局
Quality of Recovey-15, Korean version (QoR-15K)
时间窗: 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)
时间窗: 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)
时间窗: 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.
Quality of Recovey-15, Korean version (QoR-15K)
时间窗: 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)
时间窗: 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.
The World Health Organization Disability Assessment Schedule, 2nd Edition (WHODAS 2.0)
时间窗: 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)
时间窗: 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.
EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L)
时间窗: 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)
时间窗: 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.
次要结局
- Length of stay(throughout hospitalization, expected to be 2-3 days)
- Pain (Visual analogue scale)(1 month after hospital discharge)
- Total in-hospital opioid consumption(throughout hospitalization, expected to be 2-3 days)
- Complication(From enrollment to one month after discharge)
- Readmission(From enrollment to one month after discharge)
- Pain (Visual analogue scale)(on 24 hours postoperatively)
- Pain (Visual analogue scale)(1 week after hospital discharge)
研究者
Song Seung Woo
Assistant professor
Wonju Severance Christian Hospital