Evidence-Based Prospective Study of the Artificial Intelligence Risk Assessment Model for Complication Prevention in Plastic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,347
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Complications Including DVT, PTE, and ASIA Syndrome Within 2 to 41 Months Post-Surgery
研究概览
简要总结
The goal of this observational study is to determine if an AI-based risk assessment model can help prevent complications in plastic surgery patients by improving decision-making, providing recommendations to address risk factors, and assisting doctors in choosing the optimal timing and setting for elective plastic surgery. The study aims to answer if the AI model can effectively identify high-risk patients and what specific risk factors predict complications.
Purpose:
Evaluate the clinical effectiveness of an AI-based risk assessment model in preventing complications in plastic surgery patients by analyzing clinical data and patient history, providing personalized recommendations to mitigate risk factors and enhance outcomes.
Hypothesis:
The AI model can more accurately identify high-risk patients and provide effective recommendations to reduce complications compared to traditional methods.
Participants:
Individuals undergoing elective plastic surgery. They will complete an online form collecting data on age, height, weight, smoking habits, and comorbidities. The system calculates risk scores, BMI, and Caprini scores.
Study Procedures:
Risk assessment using the AI model, which evaluates multiple factors and generates personalized recommendations, including weight management, smoking cessation, blood pressure control, Doppler ultrasound for DVT, nutritional consultations, and specialist referrals. Recommendations are reviewed and approved by plastic surgeons.
Follow-Up:
The follow-up period ranges from 2 to 41 months, with a mean of 15 months. Data on patient outcomes, including complication rates and satisfaction, will be collected and analyzed.
Outcomes Measured:
Incidence of complications, the accuracy of the AI model in predicting complications, and its impact on improving surgical outcomes.
Impact:
The study aims to provide insights into AI use in plastic surgery, leading to better risk assessment tools and protocols, enhancing preoperative planning, postoperative care, and patient safety and satisfaction.
详细描述
Study Design and Procedures:
The goal of this observational study is to determine if an AI-based risk assessment model can help prevent complications in plastic surgery patients by improving decision-making, providing recommendations to address risk factors, and assisting doctors in choosing the right time and setting for elective plastic surgery.
Methodology:
The study was conducted from January 2021 to May 2024, involving 3,347 patients assessed using the AI risk assessment model in a solo practice setting. The model uses an algorithm to evaluate clinical data and patient history, calculate risk scores, highlight risk factors, and generate personalized recommendations.
Patient Assessments:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older.
- •Evaluated for elective plastic surgery.
- •Ability to provide informed consent.
- •Completion of the preoperative assessment using the AI-based risk assessment model.
- •Agreement to follow preoperative and postoperative recommendations provided by Dr. Bukret, according to the AI-based risk assessment model.
排除标准
- •Individuals under the age of
- •Patients undergoing emergency plastic surgery procedures.
- •Inability to provide informed consent due to cognitive or psychological impairment.
- •Pregnant or breastfeeding women.
- •Patients with a history of non-compliance with medical recommendations.
- •Patients currently enrolled in another clinical trial that could interfere with this study's outcomes.
结局指标
主要结局
Incidence of Postoperative Complications Including DVT, PTE, and ASIA Syndrome Within 2 to 41 Months Post-Surgery
时间窗: From enrollment to the end of treatment at 8 weeks
Postoperative complications will be assessed using a standardized complication reporting system. Complications include but are not limited to infections, hematomas, seromas, wound dehiscence, deep vein thrombosis (DVT), and pulmonary thromboembolism (PTE). Each participant will be monitored for any complications occurring within the follow-up range of 2 to 41 months (mean = 15 months) post-surgery. The presence and severity of complications, such as severe sepsis, hemorrhage, hematoma, seroma, wound dehiscence, ASIA syndrome (diagnosed up to 6 months post-surgery), infection, and pulmonary thromboembolism, will be documented during follow-up visits. The data will be collected through clinical evaluations and patient self-reports. Specific follow-up visits will be scheduled at 1 week, 2 weeks, 1 month, 2 months, 6 months, and additional follow-ups as needed based on individual patient conditions and complications.
次要结局
未报告次要终点