Protocol for Accelerated Recovery in Patients Undergoing Thoracic Surgical Procedures Adapted to the Conditions of Santa Marcelina - Itaquera Hospital - São Paulo - Brazil (PROSM). Study Randomized Comparative Between the Adoption of the Proposed Guidelines and the Traditional Method Currently Used in the Institution
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- length of hospitalization in days
研究概览
简要总结
Introduction:
Aiming at reducing costs and optimizing the use of these financial resources, several postoperative recovery protocols have emerged that aim to reduce the length of hospital stay by accelerating surgical recovery.1,2 In view of the current Brazilian political and economic scenario allied to the existing scientific knowledge on the subject , the investigators developed a protocol that aims to meet this need using resources already available and offered in brazilian public health system. The investigators called this protocol as Protocol of Operative Recovery Santa Marcelina (PROSM) that had as inspiration the protocols of accelerated postoperative recovery already used in several European health services.
Goals:
- To evaluate the impact of PROSM on the length of hospitalization in days and postoperative pain (visual analog pain scale - VAS) in patients submitted to surgical procedures performed by the thoracic surgery team of the Hospital Santa Marcelina de Itaquera.
- Evaluate the impacts of PROSM in reducing the costs (US dollars) of surgical treatment and hospitalization of these patients.
Materials and methods:
A group of 200 patients with elective pulmonary resections (segmentectomies, lobectomies or pneumonectomies) to treat neoplastic lung diseases will be selected by the investigators.
The participants will be randomized into two groups (rate of randomization 1/1).
The first group will be submitted to the standard surgical treatment that is currently used in Santa Marcelina - Itaquera hospital. The second group will be submitted to treatment with the adoption of the PROSM guidelines, which will be detailed later.
Investigators will evaluate in the two groups: surgical time in minutes, intraoperative complications: intraoperative bleeding in mililiters, need for transfusion of blood products, intraoperative clinical complications. Investigators will also evaluate the need for postoperative recovery in Intensive Care Unit (ICU), medications used to maintain the anesthetic plane during the procedure (amount of drugs in milligrams), medications used for postoperative analgesia, length of hospital stay in days, postoperative clinical complications, need for surgical re-boarding, immediate postoperative pain (VAS), postoperative pain at the time of discharge and the first outpatient return (VAS), the need for opioid analgesics at home after discharge.
After the data collection, the investigators will analyze them and make a comparative study of the costs of surgical treatment and hospitalization between the two groups. This data will be obtained from the billing department of the Hospital Santa Marcelina de Itaquera.
详细描述
Introduction:
Patients submitted to surgical procedures for the treatment of thoracic diseases, whether benign or neoplastic, are exposed to potential complications.
The main complications related to these procedures are primarily lung infections, followed by thrombotic events, cardiovascular events, and complications due to previous chronic diseases.
Faced with the occurrence of complications, these patients require a longer hospitalization period, using high cost medications, generating additional unexpected costs.
Aiming at reducing costs and optimizing the use of these financial resources, several postoperative recovery protocols have emerged that aim to reduce the length of hospital stay by accelerating surgical recovery.1,2 In view of the current Brazilian political and economic scenario allied to the existing scientific knowledge on the subject , the investigators developed a protocol that aims to meet this need using resources already available and offered in brazilian public health system. The investigators called this protocol as Protocol of Operative Recovery Santa Marcelina (PROSM) that had as inspiration the protocols of accelerated postoperative recovery already used in several European health services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
It's impossible to mask the participants, care providers and investigators, because of the apparent differences in both techniques. For this reason the data analysis will be masked to avoid influences by the other participants during the analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with elective pulmonary resections (segmentectomies, lobectomies or pneumonectomies) to treat neoplastic lung diseases.
排除标准
- •unable to read, understand and sign informed consent
- •patients with compromised performance status (ECOG greater than 2)
- •body mass below 60 kg or greater than 120 kg
- •allergy to latex
- •patients with a history of allergy to any of the drugs used in anesthesia for PROSM
- •patients with renal dysfunction
- •liver dysfunction
- •severe cardiac dysfunction (cardiac failure)
结局指标
主要结局
length of hospitalization in days
时间窗: 1825 days
To evaluate the impact of PROSM on the length of hospitalization in patients submitted to surgical procedures by thoracic surgery team of the Santa Marcelina - Itaquera hospital
postoperative pain using visual analog pain scale (VAS)
时间窗: 1825 days
To evaluate the impact of PROSM on postoperative pain in patients submitted to surgical procedures by thoracic surgery team of the Santa Marcelina - Itaquera hospital
次要结局
- costs of surgical treatment in US dollars(1825 days)
研究者
Igor Renato Louro Bruno de Abreu
Assistant physician of the thoracic surgery team of the Hospital Santa Marcelina de Itaquera
Hospital Santa Marcelina