Effectiveness of Adapted Enhanced Recovery After Surgery Protocol in Open Gynecologic Oncology Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Length of hospital stay
研究概览
简要总结
Background: In recent decades, the new concept of Enhanced Recovery After Surgery (ERAS) program has been well accepted in the fields of gynecologic surgery. Many studies have shown the effectiveness of ERAS protocol in reducing hospital's length of stay, patient's morbidity, and rate of postoperative complications while cutting back on health care cost. Thus, standard guidelines such as ACOG has strongly recommended ERAS protocol implementation into each institution. However, institutions have self-limitations on adapting the standard ERAS pathway published from ERAS society due to the demand in resources. The concept of partial implementation of ERAS protocol has been raised and was mentioned in guidelines that ERAS implementation should be individualized to each institution. Nevertheless, the effectiveness of adapted ERAS protocol itself has not been well researched.
Objectives: To examine the effect of partial implementation of ERAS protocol adapted to our institution on patient's recovery (based on hospital length of stay, pain score, time to flatulence, postoperative complications, and re-visits) compared to standard routine care in women diagnosed with gynecologic malignancy (cervix, endometrium, and ovary) undergoing elective open surgery.
Design: A randomized controlled trial in gynecologic cancers (cervix, endometrium, and ovary) women, age 18-75 years, undergoing elective open gynecologic oncology surgery at Faculty of Medicine, Chiang Mai University hospital. The participants will be randomly assigned into one of two study groups: intervention (adapted ERAS protocol) and control (standard routine care).
For the intervention group, each woman will be brought through the adapted ERAS protocol step by step starting from preoperative counseling and preparation, intraoperative management, and postoperative management standard according to the adapted ERAS protocol. For the control group, each woman will be cared for using routine standard care.
The primary outcome is length of hospital stay.
1.3 Proposed duration 24 Months
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 - 75 years old
- •Diagnosed with gynecologic malignancy of cervix, endometrium, or ovary
- •Elective laparotomy surgery
排除标准
- •Intraoperative accidental injury to urinary or GI organs
- •Retain endotracheal intubation after surgery
- •Peritoneal drainage for monitoring of bleeding/infection
- •Unable to follow oral instructions
- •Severe neuromuscular disease
- •Preoperative hyperalimentation
- •Neoadjuvant chemotherapy within 3 weeks prior to the procedure
- •Previous abdominal/pelvic radiation
- •Bowel obstruction
- •Emergency operation
结局指标
主要结局
Length of hospital stay
时间窗: Through hospital discharge, an average of 5 days
Length of hospital stay after surgery
次要结局
未报告次要终点
研究者
Kittipat Charoenkwan, MD
Associate Professor
Chiang Mai University