Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Length of Hospital Stay (LOS)
研究概览
简要总结
The Enhanced Recovery After Surgery (ERAS) program includes preoperative counseling, fasting avoidance, non-opioid analgesia, fluid balance, normothermia and early mobilization. ERAS pathways were developed to reduce hospital length of stay, reduce costs and decrease perioperative opioid requirements, and be beneficial for patients. We propose the hypothesis that the ERAS pathway could reduce the length of stay (LOS) in hospital for patients undergoing major gynecologic oncology surgery (MGOS).
Patients were randomly allocated in two groups: An ERAS pathway group including preoperative counseling, early feeding/mobilization, and opioid-sparing multimodal analgesia; and a classic model group of post operative recovery as control.
详细描述
The Gynecological Cancer of the inner genital organs includes ovarian cancer, endometrial and cervical cancer and its therapeutic approach is surgical removal of the organ with cancer.
The last decade has developed various postoperative recovery protocols aimed at safe and rapid recovery of the patient after a surgery and early discharge from the hospital. These protocols are known as ERAS (Enhanced Recovery After Surgery) protocols or Fast-Track (FT) and combine various evidence-based perioperative care techniques.
The ERAS protocols include specific approaches preoperative, intraoperative and postoperative, by the multidisciplinary team (surgeon, anesthetist and nurse), and aim at reducing the postoperative stress and pain, fasten the feeding and the mobilization of the patient after the surgery and rapid the hospital discharge.
This trial is designed to evaluate the superiority of the ERAS pathway to conventional non-ERAS clinical practice in reducing the LOS. The results may provide new insight into the clinical applications of the ERAS pathway for MGOS.
This doctoral thesis aims to compare the effectiveness of the Protocol ERAS against the classical model of recovery, in the postoperative recovery of patients with Gynecological Cancer undergoing MGOS, in a Public Oncology Hospital in Greece.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Greek language speakers
- •Have complete mental clarity
- •Age >18 years
排除标准
- •Refusal to sign consent
- •Patients receiving treatment for chronic pain
- •Patients receiving antipsychotic therapy, Psychopathy
- •They have acute or chronic kidney and / or liver disease
- •History or family history of malignant hyperthermia
- •Known allergy to propofol, desflurane, or any other anesthetic agent
- •Impairment of cognitive function or communication
- •History of postoperative delirium
结局指标
主要结局
Length of Hospital Stay (LOS)
时间窗: up to 30 postoperative days
Measuring how many days the participants will stay in hospital for the post-op recovery. It is defined as the time frame from the day of the surgery to the day of discharge from the hospital (unit: days).
Pain Levels
时间窗: up to 3 postoperative days
Evaluation of analgesia and correlation of requirements with opioid analgesics; by recording of postoperative pain levels and the evaluation of the effectiveness of analgesic treatment of patients. Using Numbered pain Scale, from 0 that means no pain at all, to 10 that means the worst pain. As lower the number on pain scale as better the outcome.
Number of Participants With the Ability to Getting up in a Chair Within 18h
时间窗: within the first 18 postoperative hours
The number of participants who had the ability to have a sit steadily on a chair himself, within the first 18 hours after the surgery.
Number of Participants With the Ability of Full Mobilization Within 18h Postoperatively
时间窗: within the first 18 hours after the surgery
The participants should be able to stand on their feet, walk in the room, go to the toilet and make a short walk in the surgical ward within the first 18 hours after the surgery. Mobilization time, which is defined as the time frame from the end of the operation until they are able to walk without external assistance (unit: hours).
Early Feeding
时间窗: up to 6 hours postoperatively
Feeding within the first 6 hours after the surgery. The participants should be able to drink clear fluids (water, tea,chamomile, apple juice, filter coffee, jelo) with or without sweeteners, given that they don't have PONV.
次要结局
- Early Mobilization of the Digestive System(within 24 hours post surgery)
- Early Discontinuation of IV Administration(within 24 h post surgery)
- Number of Participants Who Had Their Urinary Catheter Removal(within the first 24h after surgery)
- Number of Participants Who Had Their Drainage Removal Within 24h(within 24h post surgery)
- Blood Transfusion(within 48 hours post surgery)
- Postoperative Complications(up to 5 postoperative days)
- Readmission(up to 30 postoperative days)
研究者
MARIA BOURAZANI
Registered Nurse, PhD candidate
Saint Savvas Anticancer Hospital