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临床试验/NCT03382210
NCT03382210已完成不适用

Impact of a Colorectal Enhanced Recovery Program Implementation on Clinical Outcomes and Institutional Costs: A Prospective Cohort Study With Retrospective Control

University Hospital of Ferrara0 个研究点目标入组 200 人开始时间: 2013年1月11日最近更新:
适应症

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

Importance: The Enhanced Recovery Program (ERP) for perioperative care of the surgical patient reduces the postoperative metabolic response and organ dysfunction thereby accelerating functional recovery. Consequently, the hospital length of stay (LOS) may be reduced, with no increase in morbidity and mortality rates resulting in a potential economic benefit.

Objective: To determine impact on postoperative recovery and cost-effectiveness of implementing an ERP for colorectal surgery in an Italian academic center.

Design, Setting, and Participants: A prospective consecutive series of patients (N=100) undergoing elective colorectal resection completing a standardized ERP in 2013-2015 (ERP group) will be compared to patients (N=100) operated on at the same Italian University hospital in 2010-2011 (Pre-ERP group) before introducing ERP program. The exclusion criteria are: age>80 years old, ASA score IV, tumour stage IV, and inflammatory bowel disease.

Exposures: ERP for perioperative care. Main Outcomes and Measures: To evaluate the impact of colorectal ERP implementation on hospital LOS proxy of functional recovery. Secondary outcomes include: postoperative complications, 30-day readmission and mortality, protocol adherence, nursing workload, cost-effectiveness, and factors predicting prolonged hospital LOS. Patients' satisfaction in ERP group will also be prospectively evaluated.

详细描述

Introduction The Enhanced Recovery Program (ERP) is a scientific evidence-based perioperative care approach based on multidisciplinary team working and multimodal methodology, with the aim to reduce metabolic response to surgical stress and organ dysfunction induced by surgery, thereby accelerating postoperative recovery. Consequently, the hospital length of stay (LOS) after surgery would be significantly reduced, with no increase in morbidity and mortality rates 2-4 resulting in a potential economic benefit.

Although the concept of enhancing recovery after surgery implementing specific pathways is now widely recognized, the diffusion of ERPs is still limited to Northwestern Europe, USA, and Canada, and slightly less common in Southern Europe, where it prevails in Spain, Portugal, and Italy.

The implementation of an ERP relies on the establishment of a motivated multidisciplinary team including surgeons, anesthesiologists, and nurses who agree on the end points of management and act in close coordination throughout the perioperative phases (outpatients clinic, preoperative unit, operating theater, postoperative recovery room, surgical ward). It has been shown that compliance to the elements of the ERP protocol correlates with clinical outcomes.

The aim of this study is three-fold: 1) to investigate the impact of the colorectal ERP implementation in an Italian University hospital, on postoperative recovery, evaluating the efficacy (functional recovery, LOS), the safety (postoperative complications, 30-day readmission and mortality), the adherence to the protocol, the nursing workload, and the cost-effectiveness; 2) to assess the predictive factors of prolonged hospital LOS after colorectal resection; and 3) to measure patients' satisfaction in the ERP group.

Methods A prospective series of patients (N=100) undergoing elective colorectal resection and completing a standardized ERP in 2013-2015 (ERP group) at the S. Anna University Hospital in Ferrara (Italy) will be compared to a retrospective series of patients (N=100) operated on at the same academic hospital in 2009-2011 (Pre-ERP group), and before the introduction of ERP methodology. The Italian Ministry of Health will fund this study, which will begin in January 2013. In 2012 the ERP multidisciplinary team was built, the ERP protocol was prepared, and informative meetings were scheduled. All consecutive patients between the ages of 18 and 79 years of age and scheduled for elective colorectal resection will be enrolled for the study. The exclusion criteria for both groups are: age >80 years old, American Society of Anesthesia (ASA) score IV, Tumour Node Metastasis (TNM) stage IV, inflammatory bowel disease.

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

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

  • Morbidity.(Within 30 days from date of surgical operation.)
  • Nursing workload evaluated by Project de Recherche en Nursing (PRN).(From date of surgical operation to the 4th postoperative day.)
  • Cost-effectiveness.(From date of preoperative counseling to 30 days from date of surgical operation.)
  • ERP patients' satisfaction 1.(Within 40 days from date of preoperative counseling.)
  • 30-day readmission.(Within 30 days from date of surgical operation.)
  • Mortality.(Within 30 days from date of surgical operation.)
  • Predictors of prolonged LOS.(Within 10 days from date of surgical operation.)
  • ERP patients' satisfaction 2.(Within 40 days from date of preoperative counseling.)

研究者

发起方
University Hospital of Ferrara
申办方类型
Other
责任方
Sponsor

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