Prehabilitation With Exercise and Immunonutrition (Ocoxin®) in the Perioperative Management of Gynecologic Malignancies Under ERAS Protocol.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Postoperative morbidity
研究概览
简要总结
ERAS (Enhanced Recovery After Surgery) protocols are step-by-step care plans that help patients recover faster after surgery. They focus on keeping the body's normal functions, lowering stress from surgery, and supporting a quicker recovery. In gynecologic cancer surgeries, ERAS has been shown to help patients do better, have fewer problems, and leave the hospital sooner.
A prehabilitation program, in combination with ERAS protocols, aims to optimize patients' physical and psychological condition prior to surgery for gynecological cancers. Interventions may include tailored exercise, nutritional support, respiratory training, and psychological preparation. By enhancing baseline fitness and resilience, prehabilitation improves the body's ability to tolerate surgical stress, reduces complications, and facilitates a faster, smoother recovery within the ERAS framework.
详细描述
The purpose of this study is to investigate the impact of multifactorial preoperative empowerment (pre-habilitation protocol) on patients with gynecological cancer who undergo oncological surgery. The objective of this study is to demonstrate whether the implementation of pre-habilitation program empowerment as opposed to its non-implementation leads to an improvement in quality of life, a reduction in days of hospitalization, a reduction in immediate (up to discharge) and long term (up to 40th post-surgery day) postoperative complications (as measured with the Clavien Dindo system), a reduction in hospital readmission rates, and postoperative morbidity and mortality.
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Type of gynecological malignancy: endometrial cancer, ovarian cancer, cervical cancer, treated with laparotomy after the decision of the gynecological-oncology unit (positive opinion of the Multidisciplinary Tumor Board - MDT)
- •Patient age: 18 to 85 years
- •General condition of the patient: ASA score I-III
- •Consent to implement the accelerated recovery protocol - Enhanced recovery after surgery (ERAS)
- •Sufficient understanding of the Greek language
- •Provision of signed, after thorough information, consent to participate in the study
排除标准
- •Women with performance status: ECOG >2 and ASA score >III
- •Women who have not been informed and have given written consent
结局指标
主要结局
Postoperative morbidity
时间窗: Up to the 30th post operative day
Systematic recording of complications based on the Clavien Dindo system, during hospitalization and in the immediate postoperative period (up to the 30th postoperative day).
Duration of hospitalization
时间窗: Until the patient discharged (assessed up to 4 days)
The discharge day is defined as the postoperative day on which the following criteria are met in their entirety: 1. adequate mobilization, 2. tolerance of solid foods and adequate oral water intake, 3. adequate analgesia only with oral analgesics, 4. mobilization of intestinal function / flatus, 5. Absence of Clavien Dindo \>II complication.
General Quality of Life (QoL)
时间窗: Up to the time of discharge (assessed up to 4 days)
Use of metric tools: structured and weighted questionnaires in Greek language EORTC QLQ-C30 (version 3.0) (general quality of life). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
次要结局
- Time interval between the onset of adjuvant anti-neoplastic therapy(Up to 120 days after surgery)
- Hospital readmission at 90 days(Up to the 90th postoperative day)
- Cachexia(Up to the time of discharge (assessed up to 5 days))
- Sexual Health(Up to the time of discharge (assessed up to 4 days))
- Quality of Life in ovarian cancer(Up to the time of discharge (assessed up to 4 days))
- Quality of Life in endometrial cancer(Up to the time of discharge (assessed up to 4 days))
研究者
Panagiotis Tzitzis
MD,MSc
Aristotle University Of Thessaloniki