An Intense Course of Prehabilitation in Ovarian Cancer Patients During Neoadjuvant Treatment Awaiting for Interval Debulking Surgery. PREHONED - a Prospective, Randomized, Multicentre Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Frequency of postoperative complications
研究概览
简要总结
Prehabilitation includes care for patients preparing for surgery. This is a modern approach aimed at increasing the patient's functional capacity before surgery and improving postoperative results. Prehabilitation includes preoperative physical activity, nutritional intervention, psychological support, cessation of stimulants and optimization of laboratory test results.
Many studies have shown a positive effect of prehabilitation on postoperative results, mainly reducing the number of postoperative complications and shortening the hospitalization time.
The assumed time of prehabilitation is 2-6 weeks, but in the case of oncology patients, the procedure should not be delayed only for the sake of prehabilitation.
Our study includes oncology patients with ovarian cancer who are referred for neoadjuvant chemotherapy before interval cytoreductive surgery. The assumption of the study is an intensive course of prehabilitation during neoadjuvant treatment, which should provide significantly better postoperative results.
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
- None
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
- 否
入选标准
- •Patients with confirmed ovarian cancer
- •No possibility of performing primary debulking surgery (Fagotti score > 8 points). Referral patient for neoadjuvant chemotherapy
- •Consent to participate in the study
- •Age over 18 years
排除标准
- •Performing primary debulking surgery
- •Lack of consent to participate in the study
- •Aletti score < 4 points in interval debulking surgery
- •Severe neurological/psychiatric disorders that make contact with the patient difficult
结局指标
主要结局
Frequency of postoperative complications
时间窗: from surgery for the next 30 days
Analysis of the incidence of complications, including assessment according to the Clavien-Dindo classification. Analysis of complications will include the incidence of intensive care units hospitalization, frequency of reoperation, dehiscence of intestinal anastomosis, wound dehiscence with eventeration, need for blood transfusion and readmission within 30 days
Length of hospital stay
时间窗: from surgery to hospital discharge (assessed up to 14 days)
The analysis will include the length of hospitalization after surgery.
Time to start adjuvant chemotherapy
时间窗: from discharge from hospital for the next 2 months
Comparison of time from hospital discharge to start of adjuvant chemotherapy
次要结局
- Progression-free survival(From the time of the operation for the next 3 and 5 years)
- Overall survival(From the time of the operation for the next 3 and 5 years)
研究者
Marcin Zębalski
MD
Medical University of Silesia