Enhanced Recovery After Surgery: A Randomized Control Trial of Perioperative Management of Gynecologic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Length of hospitalization
研究概览
简要总结
This is a single-blinded randomized control trial comparing the current perioperative care of the investigators gynecologic oncology patients with a standardized perioperative "enhanced recovery" pathway. Adult patients undergoing laparotomy by one of the gynecologic oncology surgeons will be eligible to participate. The primary outcome will be length of hospitalization including any days of readmission in the 30 days post-operatively. Secondary outcomes will include 30-day readmission rate, complications, quality of recovery, and pain control.
详细描述
The objective of this research is to implement and evaluate an enhanced recovery pathway for gynecologic surgery patients undergoing laparotomy and compare their outcomes to the current standard of care perioperative management.
Hypothesis: Patients having a laparotomy for gynecologic disease have a shortened length of hospitalization in the 30 days post-operatively when undergoing a perioperative enhanced recovery protocol compared to the standard of care.
This study will be a randomized single-blinded control trial.
Primary Outcomes: Hospital days in first 30 days post-operatively (Length of stay of primary hospitalization plus any days of readmission)
Secondary Outcomes:
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients who are to undergo laparotomy
排除标准
- •Inability to provide informed consent
- •Inability to comprehend written or spoken English
- •Immobility as defined by inability to ambulate unassisted
- •Patient currently residing in a skilled nursing facility
- •ASA physical status 4 or 5
- •Planned greater than one night admission to the ICU
- •Pregnancy
研究组 & 干预措施
Enhanced recovery protocol
Aspects of perioperative care will be standardized. Specific protocol for pre-operative, intra-operative, and post-operative care will be followed in this group.
干预措施: Enhanced recovery protocol (Other)
Standard of care
Treating physicians will determine all aspects of patients' perioperative care. Specifically, the individual surgeon, nurse, resident, fellow, and anesthesiologist caring for the patient will determine the patients' pre-operative counseling, bowel preparation, postoperative nausea and vomiting prophylaxis, IV fluid replacement, use of drains, timing of urinary catheter removal, mobilization, post-operative nutrition, pain medication, and bowel stimulation.
结局指标
主要结局
Length of hospitalization
时间窗: 30 days post-operatively
Hospital days in first 30 days post-operatively (Length of stay of primary hospitalization plus any days of readmission)
次要结局
- Pain control(30 days post-operatively)
- Readmission rate(30 days post-operatively)
- Complications(30 days post-operatively)
- Quality of life/recovery(30 days post-operatively)