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临床试验/NCT05231473
NCT05231473已完成不适用

Impact Of The Nurse Enhanced Recovery After Surgery Coordinator On The Compliance Of Multimodal Rehabilitation Programs In Colorectal Surgery (nursERAS-BCN)

Hospital Universitari de Bellvitge1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
206
试验地点
1
主要终点
Relationship between compliance to Enhanced Recovery After Surgery program and Nurse ERAS Coordinator as assessed by ERAS Society Guidelines

研究概览

简要总结

Purpose. The aim of this study is to evaluate the impact of the implementation of the Nurse Enhanced Recovery After Surgery Coordinator (NEC), within the Enhanced Recovery After Surgery (ERAS) program, in relation to the compliance of patients undergoing colorectal surgery.

Methods. Quasi-experimental study with a control group, an intervention group and without random assignment in a multicenter trial; between December 2021 and November 2023. Patients older than 18 years with planned elective intervention of major colorectal surgery will be included; excluding those without social support, with psychiatric illness, cognitive difficulty, planning of simultaneous or emergency surgery. In the intervention arm they will have NEC and in the control group they will not have that resource. Compliance will be the main variable of the study and, in addition, the study aims to assess secondary endpoints such as quality of life (QOL).

Conclusions. NEC could increase compliance to ERAS programs, improving health outcomes and QOL perceived by the patient. The applicability in the different hospital centers could generate an opportunity to advance professionally in the nursing figure within the ERAS program. The fact of having NEC could also increase the efficiency of the program due to the cost-effectiveness of the nursing position, although this is not the object of the study. It would be applicable in improving perceived health and QOL, so it could also have an economic impact on the health system.

详细描述

Background. Fast-track Surgery or Enhanced Recovery After Surgery (ERAS), also called multimodal rehabilitation in Spain, constitutes the application of a series of perioperative measures and strategies aimed at those patients who undergo surgery with the objective to reduce surgical stress, promoting a better recovery of the patient by significantly reducing complications and mortality.

The ERAS programs have represented an important change in the surgical field since it opens a new line of action different from the traditional one. These protocols include a set of perioperative measures applied in a multidisciplinary way, whose advantages have been scientifically endorsed. However, these programs still face more traditional attitudes and practices, so their application is still limited today.

The Nurse ERAS Coordinator (NEC) was integrated into the multidisciplinary teams at the same time of implementation of the programs in the northern European countries, betting on their leadership and capacity from the beginning. This figure ensures that the ERAS guidelines advance in the process until their final approval and participate in the fulfillment of the protocol in the different phases. They carry out interventions based on as much evidence as possible and contribute to the collection of data for ongoing audits. In addition, they are characterized by high levels of communication skills, resourcefulness and innovation, these being key attributes of the ERAS coordinator and favoring the participation of the entire multidisciplinary team through organizational change.

Starting in the 1990s, two groups of surgeons presented different measures to improve the postoperative evolution of patients who underwent elective colorectal surgery. Both groups emphasized the importance of the information provided to the patient and its role in postoperative recovery. In Europe, specifically at the Hvidovre University Hospital in Denmark, the first group led by Kehlet emerged, who proposed different strategies to improve the postoperative period of these patients; also acting preoperatively and during surgery. Years later, the second group emerged in the United States, led by Delaney et al. from the Cleveland Clinic, who focused his studies on postoperative improvement based on the advances of the previous group, specifically in the administration of an early diet and the stimulation of early mobilization. In this way, the ERAS programs emerged.

However, it was not until 2001, when the ERAS group was formed, made up of different colorectal surgery units from 5 northern European countries (Scotland, Sweden, Denmark, Norway and the Netherlands). This group agreed on what they would call the ERAS project led by Kehlet. The recommended actions began at the moment of diagnosis and sought to recognize the individual needs of the patient to optimize their treatment before, during and after surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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 over 18 years of age
  • •Candidates to elective major colorectal surgery due to benign or malignant pathology

排除标准

  • •Rejection of the patient to participate in ERAS program
  • •Inadequate social support that makes it difficult to comply with a discharge planned hospital
  • •Associated psychiatric illness, mental or organic disorders which could interfere with receiving treatments or indications about the program
  • •Patients with combined surgeries or simultaneous with other specialties by synchronism.
  • •Patients with emergency surgery

研究组 & 干预措施

Standard

No Intervention

The participants are assigned according to the implanted and functioning program of each center. In this case, without Nurse Enhanced Recovery After Surgery Coordinator. It will be the control group. ERAS program will be working without this role.

Nurse Coordinator

Experimental

The participants are assigned according to the implanted and functioning program of each center. In this case, with Nurse Enhanced Recovery After Surgery Coordinator. It will be the intervention group. ERAS program will be working with this role.

干预措施: Nurse Enhanced Recovery After Surgery participation (Other)

结局指标

主要结局

Relationship between compliance to Enhanced Recovery After Surgery program and Nurse ERAS Coordinator as assessed by ERAS Society Guidelines

时间窗: 30 days

The primary endpoint is to evaluate the impact of the implementation of the Nurse ERAS Coordinator, within the ERAS program, in relation to the compliance of patients undergoing colorectal surgery in tertiary hospitals in the province of Barcelona. The percentage of adherence to the ERAS program will be compared in the hospital that has the Nurse ERAS Coordinator vs. the hospital that does not have that figure. The measurement will be carried out according to the process indicators proposed by the ERAS Society Guidelines. Wil be analyzed the relationship between protocol compliance percentage and the presence of Nurse ERAS Coordinator en each participating hospital.

次要结局

  • Quality of Life undergoing ERAS programs as assessed by EORTC QLQ CR-29 questionnaire.(90 days)
  • Quality of Life undergoing ERAS programs as assessed by EORTC QLQ C30 questionnaire.(90 days)
  • Quality of Life undergoing ERAS programs as assessed by SF-12 questionnaire.(90 days)

研究者

发起方
Hospital Universitari de Bellvitge
申办方类型
Other
责任方
Principal Investigator
主要研究者

José Antonio Jerez González

Enhanced Recovery After Surgery Coordinator

Hospital Universitari de Bellvitge

研究点 (1)

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