Enhanced Recovery Program in Laparoscopic Colorectal Surgery: an Observational Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Postoperative Hospital Length Of Stay (LOS)
研究概览
简要总结
Background: A few randomized clinical trials and meta-analysis provide evidence for enhanced recovery programs (ERPs) in colorectal surgery. Most of the evidence, however, relies on non-randomized controlled studies that have control groups being either historical or operated on at different facilities. The aim of this study was to compare a prospective series of patients undergoing elective colorectal surgery according to ERPs, with a coeval retrospective series of patients undergoing elective colorectal surgery in a different ward at the same hospital.
The primary outcome was hospital length of stay, which was used as a proxy of functional recovery. Secondary outcomes included: postoperative complications, readmission rate, mortality, and adherence to the protocol.
Materials and Methods: A prospective series of consecutive patients (N = 100) undergoing elective colorectal resection completing a standardized ERP in 2013-2015 (ERP Group) will be compared to patients (N = 100) operated at the same institution in the same period with a traditional perioperative care protocol (Non-ERP group). Despite different surgeons and ward nurses, the two groups shared the same anaesthesiologists and were located in separate wards. The exclusion criteria were: >80 years old, ASA score of IV, a stage IV TNM, and diagnosis of inflammatory bowel disease.
详细描述
- Introduction
One of the most important achievements in modern surgery is the implementation in perioperative care of Enhanced Recovery Programs (ERPs), pioneered by Henrik Kehlet in the mid-1990s [1]. ERP is an evidence-based perioperative care approach, involving a multidisciplinary team work including surgeons, anaesthesiologists, dieticians, and nurses, which aim to reduce the surgical stress and metabolic responses as well as organ dysfunction, thus leading to a faster recovery after surgery [2].
Such a team works with a multimodal approach to perioperative care, sharing all the endpoints of management throughout the perioperative phases, and acting in close relationship with the patient along his/her "journey in hospital". In other words, each perioperative phase comprises several core items based on solid scientific evidence that are delivered by different professionals in different parts of the hospital [2].
A few randomized clinical trials and meta-analysis provide evidence in the literature for the benefits of ERPs in colorectal surgery [3-6]. Most non-randomized controlled studies have compared patients undergoing colorectal enhanced recovery surgery with controls being either historical groups or patients operated on at different hospitals [7-9].
In a previous investigation, the investigators showed the benefits of implementing an ERP in elective colorectal surgery by comparing a prospective series of 100 patients operated on receiving enhanced recovery care (ERP group), with a retrospective cohort of 100 patients operated on by the same professionals at the same institution before the introduction of the ERP (Pre-ERP group) [10].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective colorectal resection at the S. Anna University Hospital in Ferrara (Italy)
排除标准
- •age >80 years old,
- •American Society of Anesthesia (ASA) score IV,
- •TNM stage IV,
- •inflammatory bowel disease
结局指标
主要结局
Postoperative Hospital Length Of Stay (LOS)
时间窗: Within 10 days from date of surgical operation
The postoperative hospital LOS, proxy of functional recovery, is defined as the number of days from the date of surgical operation to the date of hospital. Patients in both study groups wil be discharged from the hospital upon reaching all predefined discharged criteria. For the ERP group it is estimated a 4 to 5-day hospital LOS according to the protocol, while in the traditional group an 8 to 10-day hospital stay is expected.
次要结局
- Mortality(Within 30 days from date of surgical operation)
- 30-day readmission(Within 30 days from date of surgical operation)
- Adherence to the ERP protocol(Within 10 days from date of surgical operation)
- Morbidity(Within 30 days from date of surgical operation)