Implementation of the Enhanced Recovery in Abdominal Surgery Pathway in the National Health Network (IMPRICA Project)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 2,000
- Locations
- 3
- Primary Endpoint
- Mortality
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Mortality
Time Frame: 3 years
Number of patients dead after surgery
Long term mortality
Time Frame: 5 years
Number of patients dead after surgery
Number of patients with postoperative complications
Time Frame: 30 days after surgery
complications after surgery
Secondary Outcomes
- Hospital stay(perioperative stay)
- compliance of the protocol(1 month after surgery)
- re-admission(1 month after surgery)
- Cost(1 month after surgery)