Implementation of an ERAS Program in Patients Undergoing Thoracic Surgery at a Third-level University Hospital. An Ambispective Cohort Study
Conditions: Thoracic Surgery
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Implementation of an ERAS program in patients undergoing thoracic 
surgery at a third-level university hospital. An ambispective cohort 
study. 
(Short title: ERAS implementation in thoracic surgery) 
 
31/12/2019 
 
NCT ID not yet assigned 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
METHODS 

Study design and participants 
 
This study analyzes the implementation of an ERAS program in a thoracic service 
of a third level hospital (Hospital Fundación Jiménez Díaz, Madrid, Spain). To this end, 
we designed an ambispective cohort study, with a prospective arm of patients 
undergoing thoracic surgery within an ERAS program versus a retrospective arm of 
patients before the implementation of the protocol. Our centre's ethics committee 
approved our study before the start of patient recruitment, January 2018 Ref: EO071-
18_FJD. This study followed the Strengthening the Reporting of Observational Studies 
in Epidemiology (STROBE) reporting guideline for cohort studies13. 
 
After informed consent, we included patients consecutively since the 
implementation, except those who refused the inclusion in the study or were under 18 
years old. We also asked for informed consent from the patients who were part of the 
retrospective cohort. For the calculation of the required sample size, we assumed that 
the ERAS program would result in a 25% reduction in the absolute risk of suffering a 
surgical complication. Since the surgical complication rate for our patients in 2016 was 
40%, a type-I error of 5% and a power of 80% would require 47 patients per arm.  
 
Procedures 
 
We recruited 50 patients throughout 2018 and 2019 and compared them with 
data from the last 50 patients in 2016, the year in which we knew the surgical 
complication rate. We followed up each patient for 30 days after surgery through hospital 
and primary care medical records. Demographic and comorbidity data were collected 
from all patients, from which we calculated Charlson's comorbidity index14 for all patients.  
 
We designed our centre's ERAS program through different measures during the 
preoperative, intraoperative and postoperative period. During the preoperative period, 
the patients and their families received comprehensive multidisciplinary information 
about the protocol, as well as their daily goals and expected discharge date. Also, a team 

specialized in therapy against lung diseases taught patients pulmonary expansion 
exercises to be carried out until surgery was performed. Smoking cessation and 
nutritional screening of the patient were also part of this stage. 
 
The patients underwent video-assisted thoracoscopic surgery (VATS), whenever 
possible, leaving a chest tube at the end of the surgery. All subjects received antibiotic 
and antithrombotic prophylaxis. Intraoperative management of patients was performed 
under general anaesthesia combined with regional techniques for pain control, avoiding 
the use of benzodiazepines and opioids. Those patients in whom thoracic epidural 
catheter was implemented during surgery continued its use through a patient-controlled 
analgesia system. Besides, a hot air system warmed the patients during surgery to 
maintain normothermia. Extubation was performed as soon as possible after the end of 
the surgery, and we encouraged early removal of the urinary catheter. 
 
From the time of extubation, the patients began oral tolerance and respiratory 
physiotherapy exercises. Also, the patients were allowed to walk around early. The 
patients were discharged when they were free of complications, without severe pain, 
urinary catheter or chest tube. 
 
Outcomes 
 
The primary outcome was the number of patients with 30-day surgical 
complications. We defined air leakage, bleeding, infection, and reintervention as surgical 
complications. 
Secondary 
outcome 
included 
ERAS 
adherence, 
no-surgical 
complications, mortality, readmission, reintervention rates, pain (defined as any level of 
pain that prevents early ambulation) and hospital lenght of stay. To evaluate ERAS 
adherence, we defined seven items: VATS approach, regional analgesia, oral tolerance 
within 6 hours, urinary catheter removal within 24 hours, ambulation within 24 hours, 
respiratory physiotherapy within 24 hours and chest tube removal within 48 hours.