Enhanced Recovery After Surgery in Extremity Sarcoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Clinical outcomes - opioid requirements
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of implementing the enhanced recovery after surgery (ERAS) pathway in a prospective manner to patients undergoing surgical treatment for extremity sarcoma.
详细描述
Specifically, the focus of this study will be regarding the administration of a perioperative non-narcotic, multimodal pain management pathway. Primary endpoints collected with be short-term patient reported outcomes (pain scores [PROMIS] and [QoR-15]), limb function scores [MSTS], and key clinical outcomes (hospital length of stay, opioid requirements/prescribing data and perioperative complications).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Any patient at Vanderbilt University Medical Center treated with surgical excision of a suspected extremity sarcoma
- •Adult patients >17 years of age
- •Patients of all preoperative opioid status (naïve or dependent)
排除标准
- •Patients treated non-operatively
- •Non-English speaking patients
研究组 & 干预措施
ERAS
Administration of a perioperative non-narcotic, multimodal pain management pathway.
干预措施: Enhanced Recovery After Surgery (Procedure)
Non-ERAS (Conventional)
Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications.
结局指标
主要结局
Clinical outcomes - opioid requirements
时间窗: 3 months
Measured by the amount of opioids consumed
Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission)
时间窗: 3 months
Measured by the number of perioperative complications reported
Limb function
时间窗: 3 months
Measured by Musculoskeletal Tumor Society scoring system (MSTS) scored from 0-5 (5 being best and 0 being worst)
Clinical outcomes - length of hospital stay
时间窗: 3 months
Measured by the number of days in the hospital
Pain scores
时间窗: 3 months
Measured by Quality of Recovery questionnaire (QoR-15) scale = 0-10 (0=none of the time and 10 = all of the time)
次要结局
未报告次要终点
研究者
Joshua Lawrenz
Principal Investigator
Vanderbilt-Ingram Cancer Center