Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Hospital Stay
研究概览
简要总结
Over 600,000 hysterectomies are performed annually in the United States. Despite increasing use of less invasive approaches, the majority of hysterectomies are still performed via traditional laparotomy, which can be associated with generally slower recovery and longer lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as possible following surgery.
详细描述
Subjects will be randomly assigned to one of two groups: Rapid recovery protocol (regional anesthesia, pain control options with emphasis on nonsteroidal anti-inflammatory drugs (NSAIDS) over narcotic pain medications, early ambulation, and early enteral feeding) or standard of care (traditional laparatomy and supportive care).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women who are being seen at the Women's Health Center by the Gynecologic Oncology group at the University of Minnesota if planned surgery includes an exploratory laparotomy
排除标准
- •< 19 years old
- •Undergoing a procedure other than laparotomy
- •Scheduled to be discharged the same day of surgery
- •Chronic narcotic pain medication user
- •American Society of Anesthesiologists (ASA) score of > or = 3
- •Any condition that would exclude women from undergoing regional anesthesia
研究组 & 干预措施
Control Group (Standard Laparotomy)
Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
干预措施: Laparotomy (Procedure)
Control Group (Standard Laparotomy)
Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
干预措施: intravenous narcotics (Drug)
Control Group (Standard Laparotomy)
Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
干预措施: standard anesthesia (Drug)
Rapid Recovery Group
Protocol for "rapid recovery laparotomy" procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.
干预措施: Laparotomy (Procedure)
Rapid Recovery Group
Protocol for "rapid recovery laparotomy" procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.
干预措施: regional anesthesia (Drug)
Rapid Recovery Group
Protocol for "rapid recovery laparotomy" procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.
干预措施: Non-steroidal anti-inflammatory drugs (Drug)
结局指标
主要结局
Hospital Stay
时间窗: 1 Month
Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge
次要结局
- Pain Medications Used(Post operative - day 2)
- Pain Assessment(Day 0)