Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecologic Oncology: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Postoperative recovery time
研究概览
简要总结
Prospective, interventionist, controlled and randomized study to test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
详细描述
Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to multidisciplinary team and blind to surgeons and anaesthesiologists. The aim is test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERAS®) guidelines will be applied.
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 (Investigator)
盲法说明
Single-Blind (surgeons and anesthesiologists)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who sign the Informed Consent Form, indicating that they understand the study procedures and their purpose;
- •Women aged between 18 and 80 years old;
- •Gynecological surgery performed by laparotomy;
- •Patients with Eastern Cooperative Oncology Group Performance Status of at least 2 (ECOG ≤2);
- •Preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks
排除标准
- •Patients under 18 or older than 80 years old;
- •Significant comorbidities, such as: neurological or musculoskeletal disorder, heart disease and / or respiratory failure that prohibit physical exercise;
- •Limitation of ambulation preventing the patient to perform physical exercises;
- •Cognitive deterioration or patients with psychiatric disorder that prevents adherence to the program;
- •Emergency or urgency surgeries;
- •Surgeries by minimally invasive approach (laparoscopy or robotics);
- •Vulvectomy or soft tissue surgery without abdominal approach;
- •Minor gynaecological surgeries such as conizations;
- •Surgeries performed together with other specialties, in which the gynecology team is not primarily responsible for postoperative care;
- •If surgery is performed 21 days after the last day of the prehabilitation program, for any reason
结局指标
主要结局
Postoperative recovery time
时间窗: Up to 30 postoperative days
Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs
次要结局
- Complications and Adverse Effects(Up to 30 postoperative days)
- Readmissions(Up to 30 postoperative days)
- Health-related Quality of Life(At Baseline, the week before surgery, then at postoperative days 7, 30 and 60)
- Intensive Care Unit admission rates(Up to 30 postoperative days)
- Compliance to the ERAS® program guideline(Up to 30 postoperative days)
- Changes in anxiety and depression from baseline(At Baseline, the week before surgery, then at postoperative days 7, 30 and 60)
- Changes in functional capacity from baseline(At Baseline, the week before surgery, then at postoperative days 30 and 60)
- Change in muscle strength(At Baseline, the week before surgery, then at postoperative days 30 and 60)
- Change in body mass(At Baseline, the week before surgery, then at postoperative days 30 and 60)
- Hospital stay(Up to 30 days)
- Use of opioids in acute postoperative pain(Up to 30 days)
研究者
André Lopes
MD
Instituto Brasileiro de Controle do Cancer