Implementation of Enhanced Recovery Protocol in Spain

Major Surgery Clinical Trial

— IMPRICA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03803280
• Other study ID #: GERM03
• Status: Recruiting
• Start date: July 15, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Grupo Español de Rehabilitación Multimodal
• Contact: Jose M Ramirez, Prof
• Phone: +34 639776364
• Email: jramirez[@]unizar.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Major Surgery

Intervention

Procedure:
• ERAS program
ERAS pathway according to the Spanish Via RICA

Locations

Country	Name	City	State
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Complejo Hospitalario de Salamanca	Salamanca
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Grupo Español de Rehabilitación Multimodal	Instituto Aragones de Ciencias de la Salud, Instituto de Investigación Sanitaria Aragón

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Arroyo A, Ramirez JM, Callejo D, Viñas X, Maeso S, Cabezali R, Miranda E; Spanish Working Group in Fast Track Surgery (GERM). Influence of size and complexity of the hospitals in an enhanced recovery programme for colorectal resection. Int J Colorectal Di — View Citation

Bruna Esteban M, Vorwald P, Ortega Lucea S, Ramírez Rodríguez JM; Grupo de Trabajo de Cirugía Esofagogástrica del Grupo Español de Rehabilitación Multimodal (GERM). Enhanced recovery after surgery in gastric resections. Cir Esp. 2017 Feb;95(2):73-82. doi: — View Citation

Bruna M, Navarro C, Báez C, Ramírez JM, Ortiz MÁ. Results of a national survey about perioperative care in gastric resection surgery. Cir Esp (Engl Ed). 2018 Aug - Sep;96(7):410-418. doi: 10.1016/j.ciresp.2018.03.004. Epub 2018 Apr 24. English, Spanish. — View Citation

Esteban F, Cerdan FJ, Garcia-Alonso M, Sanz-Lopez R, Arroyo A, Ramirez JM, Moreno C, Morales R, Navarro A, Fuentes M. A multicentre comparison of a fast track or conventional postoperative protocol following laparoscopic or open elective surgery for color — View Citation

Gonzalez-Ayora S, Pastor C, Guadalajara H, Ramirez JM, Royo P, Redondo E, Arroyo A, Moya P, Garcia-Olmo D. Enhanced recovery care after colorectal surgery in elderly patients. Compliance and outcomes of a multicenter study from the Spanish working group o — View Citation

Martínez AB, Longás J, Ramírez JM. A model for lymphocyte activation in open versus laparoscopic surgery in colorectal cancer patients in enhanced recovery after surgery (ERAS) protocols. Int J Colorectal Dis. 2017 Jun;32(6):913-916. doi: 10.1007/s00384-0 — View Citation

Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Pr — View Citation

Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Associati — View Citation

Ramírez JM, Blasco JA, Roig JV, Maeso-Martínez S, Casal JE, Esteban F, Lic DC; Spanish working group on fast track surgery. Enhanced recovery in colorectal surgery: a multicentre study. BMC Surg. 2011 Apr 14;11:9. doi: 10.1186/1471-2482-11-9. — View Citation

Ruiz-Tovar J, Muñoz JL, Royo P, Duran M, Redondo E, Ramirez JM; Grupo Español de Rehabilitación Multimodal (GERM). Implementation of the Spanish ERAS program in bariatric surgery. Minim Invasive Ther Allied Technol. 2018 Dec;27(6):365-372. doi: 10.1080/13 — View Citation

Ruiz-Tovar J, Royo P, Muñoz JL, Duran M, Redondo E, Ramirez JM; GERM. Implementation of the Spanish National Enhanced Recovery Program (ERAS) in Bariatric Surgery: A Pilot Study. Surg Laparosc Endosc Percutan Tech. 2016 Dec;26(6):439-443. — View Citation

Vorwald P, Bruna Esteban M, Ortega Lucea S, Ramírez Rodríguez JM; Grupo de Trabajo de Cirugía Esofagogástrica del Grupo Español de Rehabilitación Multimodal (GERM). Enhanced recovery after esophageal resection. Cir Esp (Engl Ed). 2018 Aug - Sep;96(7):401- — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with postoperative complications	complications after surgery	30 days after surgery
Primary	Mortality	Number of patients dead after surgery	3 years
Primary	Long term mortality	Number of patients dead after surgery	5 years
Secondary	Hospital stay	Days of stay in hospital after surgery	perioperative stay
Secondary	compliance of the protocol	Rate of compliance of each ERAS (Enhanced Recovery After Surgery) item	1 month after surgery
Secondary	re-admission	patient needing hospital stay after being at home after primary surgery	1 month after surgery
Secondary	Cost	Price of the intervention	1 month after surgery