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

NCT05231473 | Completed

• 1 other identifier: PR426/21
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ERAS; Enhanced Recovery; Compliance, Treatment; Compliance, Patient; Nurse's Role; Colon Disease; Rectum Disease

Outcome Measures

Primary Outcomes (1)

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

  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.

  30 days

Secondary Outcomes (3)

• Quality of Life undergoing ERAS programs as assessed by SF-12 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 EORTC QLQ CR-29 questionnaire.

  90 days

Study Arms (2)

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.

Other: Nurse Enhanced Recovery After Surgery participation

Interventions

Nurse Enhanced Recovery After Surgery participation OTHER

Bellvitge University Hospital will include the NEC participation along Enhanced Recovery After Surgery program.

Also known as: NEC participation

Nurse Coordinator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Germans Trias i Pujol Hospital: collaborator
• University of Barcelona: collaborator

Study Sites (1)

Bellvitge University Hospital

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (31)

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  BACKGROUND

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MeSH Terms

Conditions

Patient Compliance; Colonic Diseases; Rectal Diseases

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jose Antonio Jerez-Gonzalez, MSc

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

• M.Carmen Moreno-Arroyo, PhD

  University of Barcelona

  STUDY DIRECTOR

• Miguel Angel Hidalgo-Blanco, PhD

  University of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Enhanced Recovery After Surgery Coordinator

Model Details: This study is designed as a quasi-experimental study with a control group, an intervention group, without random assignment and multicenter trial; which is carried out at two centers in Barcelona, Spain: Bellvitge University Hospital (BUH) and Hospital Germans Trias i Pujol (HGTiP), between December 2021 and November 2023. The participants are assigned according to the implanted and functioning program of each center, to one of two arms: a control arm, in which they join the ERAS program without NEC (group I), and an intervention arm, in which the participants will be included in the ERAS program with NEC (group II). In HGTiP, the ERAS program without NEC is carried out in a standardized way, and in BUH it is carried out with NEC for all patients. The study directly compares both programs and their compliance in patients who are candidates for elective colorectal surgery.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 9, 2022
• Study Start: May 1, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)