Applicability of Enhanced Recovery After Surgery Protocols in the Therapeutic Endoscopy Suite: a Single-Center Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- airway protection
研究概览
简要总结
This study aims to investigate the impact of implementing ERAS protocols on patient outcomes in therapeutic endoscopy, focusing on patients undergoing ESD. Although considered a less invasive alternative to conventional surgical resection, ESD can still result in significant physiological stress, postoperative discomfort, and potential complications. By exploring the application of ERAS principles to therapeutic endoscopy and evaluating their effectiveness, this study aims to address the current lack of knowledge in this field and promote the adoption of ERAS principles in managing ESD patients. Ultimately, the goal is to assess if the implementation of the ERAS process in these therapeutic endoscopy procedures can reduce procedure-related complications, improve patient outcomes, and enhance after-procedural recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All >18 years-old patients scheduled for ESD for any indication;
- •Patients who were able to give informed written consent.
排除标准
- •- Patients who were not able or refused to give informed written consent.
结局指标
主要结局
airway protection
时间窗: during procedure
Desaturations, aspiration or any acute event requiring airway protection
Rate of ESD-related adverse events
时间窗: 48 hours after procedure
such as bleeding or perforation (defined as any such procedure-related complication that compromises the completeness of the procedure and/or results in the unplanned patient hospital admission) or occurrence of Post Endoscopic submucosal dissection Coagulation Syndrome (PECS). (defined as the presence of signs of inflammation, such as fever, leukocytosis or C-reactive protein in the presence of localized abdominal pain in patients without evidence of perforation to
次要结局
- Abdominal pain(at 3 and 6 hours after endoscopy)
- Overall patient satisfaction(24-48 hours after procedure)
- PADSS: Post Anesthetic Discharge Scoring System (evaluated from 0 to 2, using: Vital signs, Activity and mental status, Pain, nausea and/or vomiting, Surgical bleeding, Intake and output)(in the first 4 hours after ESD)
- Post-procedural Recovery(24-48 hours after procedure)
- Analgesic requirements(in the 24 hours after ESD)