Implementation of Enhanced Recovery Protocol in Spain (IMPRICA)

January 13, 2022 updated by: Grupo Español de Rehabilitación Multimodal

Implementation of the Enhanced Recovery in Abdominal Surgery Pathway in the National Health Network (IMPRICA Project)

The main objective is the multicenter and uniform implementation of a agreed upon perioperative evidence based program emanated from the Enhanced Recovery for abdominal surgery pathway (RICA) published by the Spanish National Health Service and the Aragon Institute of Health, in hospitals of the National Health Network.

The evaluation and outcomes of such implementation is proposed as a secondary objective. Different established indicator will compared traditional care results with those from the new program in the short and medium term. 10 interested hospital centers are selected. In each of them a retrospective study will be conducted to analyze the clinical results obtained in abdominal surgery in the past six months. After making the necessary training to clinical teams and assure the project development and implementation in each center, a prospective study in which all patients in the program are being recruited will be held. Hospital stay as well as perioperative mortality and morbidity will be collected. We will analyze data from: days of hospital stay (potential and actual), efficiency (cost/procedure), quality of care, time to complete reintegration into family, social and labor environment and quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A uniform, consensual and multicentric implementation of the multidisciplinary Perioperative Medicine Program is proposed, the program comes form the Clinical Pathway of Intensified Recovery in Abdominal Surgery -RICA-, published by the Spanish National Health System as clinical guideline.

It covers the perioperative area in complex abdominal surgery and extends from the moment of diagnosis in the Surgery office until the last revision performed one year after surgery.

It is proposed as a double study; a first retrospective analysis of the results and perioperative complications referred and available in the Centers involved in the study; and a second analysis of results after the implementation of the Program, in the same Centers. Once both are finished, the comparison between them and their communication will be carried out using the appropriate reports.

Actors: Multidisciplinary teams made up of nurses, surgeons, anesthesiologists, nutritionists / endocrinologists, physiotherapists and rehabilitators.

Patients: All patients recruited in the different hospitals for the RICA Perioperative Medicine Program susceptible to performing complex abdominal surgery.

Variables under study: Perioperative complications according to the Clavien-Dindo classification and the European Perioperative Clinical Outcome definitions (EPCO); Times of global hospital stay and in critical care units; the rate of readmissions and the complications derived from them, the rate of surgical reoperations, the analysis of cost per process (including the total cost in the study period-two years-), the time until complete reincorporation into the family environment and socio-labor, the indices of quality perceived by the patient and / or their caregivers, the final quality of life index obtained by each patient (resulting quality of life).

Data collection and analysis: Record of described variables were be included in an "on line"database available to all centers.

Limitations of the Study: impossibility to include all the patients that can be recruited in surgery consultations due to rejection of the staff (negative to the benchmarking and / or to the program) or negative of the patient. Loss of data in follow-up due to the failure of patients. Difficulty in analyzing costs due to lack of economic data in the Centers. Lack of motivation in the multidisciplinary teams. Rupture of the program in case of emergency / emergency.

Material and Methodology:

Participating Centers: Previously selected for their well-known Organizational capacity and their experience and interest.

First Phase: Realization of retrospective study of existing results in each Center in the six months prior to the implementation of the Program and Conformation of the multidisciplinary teams that will implement the Intensified Recovery Program.

Second phase: Training of the Teams in IACS (Instituto Aragones Ciencias de la Salud) on the implementation of enhanced recovery programs provided with online training through platform built "ad hoc" and in person for training with experts. Development of the Normalized Work Protocol (NTP) in each assigned Center and implementation of the forms and database in the Clinical History of the Centers (considering electronic Clinical History).

Third phase: Progressive recruitment of patients and inclusion in the Program (on-line database) and start of the one-year prospective study from the patient's inclusion.

Inclusion Criteria:

-Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes. (It is defined as complex major surgery that lasts more than two hours, it is estimated that it may require the transfusion of at least 2 red cell concentrates or it is estimated a loss greater than or equal to 15% of the patient's blood volumen).

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Infanta Leonor
      • Salamanca, Spain
        • Recruiting
        • Complejo Hospitalario de Salamanca
        • Contact:
        • Principal Investigator:
          • Domingo Bustos García
        • Sub-Investigator:
          • María Angoso Clavijo
      • Zaragoza, Spain
        • Recruiting
        • Hospital Clinico Universitario Lozano Blesa
        • Sub-Investigator:
          • Rubén Casans Francés, Phd
        • Sub-Investigator:
          • Manuela Elia Guedea
        • Sub-Investigator:
          • Elena Córdoba Díaz de Laspra
        • Sub-Investigator:
          • José A Gracia Solanas
        • Sub-Investigator:
          • Julia Guillén Antón
        • Sub-Investigator:
          • Tomás Ruiz Garcés

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes (It is defined as complex major surgery that lasts more than two hours or it is estimated that it may require the transfusion of at least 2 red cell concentrates or it is estimated a loss greater than or equal to 15% of the patient's blood volumen).

Description

Inclusion Criteria:

• Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes.

Exclusion Criteria:

  • Urgent Surgery.
  • Patients ASA (American Society of Anesthesiology) IV or higher.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Traditional care
Patients with major abdominal surgery without before a enhanced recovery program was stablished
ERAS care
Patients with major abdominal surgery within a enhanced recovery program was stablished
Procedure: ERAS program
ERAS pathway according to the Spanish Via RICA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with postoperative complications
Time Frame: 30 days after surgery
complications after surgery
30 days after surgery
Mortality
Time Frame: 3 years
Number of patients dead after surgery
3 years
Long term mortality
Time Frame: 5 years
Number of patients dead after surgery
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: perioperative stay
Days of stay in hospital after surgery
perioperative stay
compliance of the protocol
Time Frame: 1 month after surgery
Rate of compliance of each ERAS (Enhanced Recovery After Surgery) item
1 month after surgery
re-admission
Time Frame: 1 month after surgery
patient needing hospital stay after being at home after primary surgery
1 month after surgery
Cost
Time Frame: 1 month after surgery
Price of the intervention
1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Español de Rehabilitación Multimodal

Collaborators

Instituto Aragones de Ciencias de la Salud
Instituto de Investigación Sanitaria Aragón

Investigators

  • Study Chair: Jose M Calvo, Dr, Grupo Español de Rehabilitación Multimodal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2016

Primary Completion (ANTICIPATED)

July 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

January 11, 2019

First Posted (ACTUAL)

January 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • GERM03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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