ERAS Lazio Network Clinical Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Adherance to ERAS protocol
研究概览
简要总结
Enhanced recovery after surgery (ERAS) protocols are programs aiming to implement patients recovery following surgical procedures developed about 25 years ago. ERAS protocols are based on a multi-disciplinary approach encompassing surgery, anesthesiology, nutrition and nursing; each specialty has to fulfill a number of items which have been demonstrated to reduce morbidity rates, hospital stay and to implement functional recovery comparing standard approach. Accordingly, ERAS society developed a Guidelines for a number of procedures, including colorectal.
The aim of this study is to evaluate the adherence over the last years to these protocols in eight Department of Surgery in Rome in a series of colorectal cancer patients.
Secondary aims are to investigate the correlation of the items adherence with surgical outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional base.
详细描述
Background. The acronym ERAS (Enhanced Recovery After Surgery) refers to a patient-centered, evidence-based multi-disciplinary protocol designed to implement perioperative operation, reduce surgical trauma, and facilitate recovery of physiological functions aiming to an early hospital discharge.
Usually ERAS protocols give a continuum of care starting at home (pre-hospital/pre-admission phase) to continue in followed by the pre-/ intra-/ and post-operative phases.
ERAS includes a wide range of disciplines and specialists, which focus on the needs of the patient in order to improve support by facilitating his return home.
The first author to introduce the fast-track term in rectal surgery was Prof. Henrik Kehlet in the mid-1990s, proposing a multi-modal rehabilitation program aimed to reduce post-surgical stress response, morbidity, mortality and postoperative hospitalization. Since then, a number of studies were conducted leading to the first ERAS protocol; since then, these protocols were reviewed on a regular basis, the last time in 2017 and included in the guidelines by the ERAS society (http://www.erassociety.org).
Currently, it is widely demonstrated that, comparing to a traditional approach, ERAS is associated with a significant reduction in morbidity, days of hospitalization, mortality, implementing early postoperative recovery with a consequent reduction of the costs, without compromising patient safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective colorectal surgical resection
- •Open and Laparoscopic Suregry
- •Benign/malignant disease
- •independently from age, sex,
排除标准
- •Emergency colorectal resections
结局指标
主要结局
Adherance to ERAS protocol
时间窗: 36 months
Number of items included in the ERAS protocols that were applied in each centre
次要结局
- Number of items of the ERAS protol correlated wih adverse events as described by the Clavien Dindo Classification and with a longer hospital stay(36 months)
研究者
PERSIANI ROBERTO
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
