SOPHIE: Surgery in Ovarian Cancer With PreHabilitation In ERAS: Prospective Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Incidence of postoperative complications
研究概览
简要总结
The treatment of choice in advanced ovarian cancer is a cytoreductive surgery combined with chemotherapeutic treatment. This complex and aggressive surgery is associated with high postoperative complication rates that may result in a strong negative impact on the clinical results due to the delay with the start of adjuvant chemotherapy as well as the costs from the surgical process. Multimodal prehabilitation has emerged as an innovative intervention that focuses on optimizing physiological and psychological resilience to withstand the upcoming stress of surgery. It has been shown to reduce postoperative complications in major abdominal surgery, but has not been assessed yet in abdominal onco-gynecological surgery.
详细描述
Main objective: To determine the efficacy of multimodal prehabilitation in decreasing postoperative complications in patients undergoing gynecological cancer surgery of high complexity by laparotomy (primary cytoreductive surgery, interval surgery and secondary cytoreductive surgery in advanced ovarian cancer).
Design: Multicenter randomized controlled clinical trial. Subjects: 146 patients: 73 in the intervention group and 73 in the control group.
Intervention group: PreHAB intervention consists on:
- High-intensity endurance exercise training program and physical activity promotion remotely controlled with ICT (information and communications technologies).
- Nutritional counselling to achieve protein intake of 1.5-1.8 g/kg and whey protein supplements.
- Psychological coping. Control group will receive standard preoperative care. Both groups will receive perioperative care in accordance with the enhanced recovery after surgery (ERAS) guidelines.
Measures: Aerobic capacity (incremental stress test), physical activity, operative complications and hospital length and associated costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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 with advanced ovarian cancer subject to primary debulking surgery or interval surgery after 3-4 cycles of chemotherapy or secondary and / or tertiary debulking surgery .
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status 2-
- •Adherence of at least 75 % of the program or minimum of 6 sessions.
排除标准
- •Surgery without a minimum of 3 weeks of prehabilitation time.
- •Unstable respiratory or heart disease.
- •Locomotor or cognitive limitations that makes not feasible the adherence to the program.
- •Refusal of the patient.
研究组 & 干预措施
Usual care
Control group will follow the standard preoperative measures "Enhanced Recovery After Surgery" (ERAS®) established in the protocols of our hospital. Standard preoperative measures: recommendation of nutritional and physical activity and advice to stop smoking and reduce alcohol intake; optimization of preoperative pathologies including anaemia. An information document on ERAS® measures in our center will be attached to all of them.
Multimodal prehabilitation
Patients following the standard preoperative policies of our institution and the multimodal prehabilitation program
干预措施: Multimodal Prehabilitation (Other)
结局指标
主要结局
Incidence of postoperative complications
时间窗: 30 days
Any deviation from the normal postoperative course and according its severity to the Clavien-Dindo classification, will be considered a complication. A comprehensive complication index (CCI) scale will be used which assigns a value to each Clavein-Dindo level so a weighted average of the severity of complications can be calculated not only in a qualitatively way, but also numerically.
次要结局
- Preoperative and postoperative aerobic capacity(baseline, 1 and 3 month post intervention)
- Hospital and ICU (intensive care unit) length of stay(postoperative 30 days)
- Health Related Quality of Life assesed by EORTC QLC-C30(Baseline and 1 month postoperative)
- Overall and disease-free survival of the study groups(5 years)
- Compliance to the ERAS program.(postoperative 30 days)
- Interval of days between surgery and the start of chemotherapy(From date of surgery up to 6 months)
- Cost-effectiveness(Baseline up to 30 days after surgery)
- Incidence of cognitive deficit(Baseline and 1 month postoperative)
- Nutritional status(Baseline and 1 month postoperative)
研究者
Berta Diaz-Feijoo
Study Director
Hospital Clinic of Barcelona