Impact of a Colorectal Enhanced Recovery Program Implementation on Clinical Outcomes and Institutional Costs
Condition: Colorectal Surgery; Recovery of Function; Laparoscopic Surgery
Study type: Observational

Summary: 
      Importance: The Enhanced Recovery Program (ERP) for perioperative care of the surgical
      patient reduces the postoperative metabolic response and organ dysfunction thereby
      accelerating functional recovery. Consequently, the hospital length of stay (LOS) may be
      reduced, with no increase in morbidity and mortality rates resulting in a potential economic
      benefit.

      Objective: To determine impact on postoperative recovery and cost-effectiveness of
      implementing an ERP for colorectal surgery in an Italian academic center.

      Design, Setting, and Participants: A prospective consecutive series of patients (N=100)
      undergoing elective colorectal resection completing a standardized ERP in 2013-2015 (ERP
      group) will be compared to patients (N=100) operated on at the same Italian University
      hospital in 2010-2011 (Pre-ERP group) before introducing ERP program. The exclusion criteria
      are: age>80 years old, ASA score IV, tumour stage IV, and inflammatory bowel disease.

      Exposures: ERP for perioperative care. Main Outcomes and Measures: To evaluate the impact of
      colorectal ERP implementation on hospital LOS proxy of functional recovery. Secondary
      outcomes include: postoperative complications, 30-day readmission and mortality, protocol
      adherence, nursing workload, cost-effectiveness, and factors predicting prolonged hospital
      LOS. Patients' satisfaction in ERP group will also be prospectively evaluated.
    

Detailed description: 
      Introduction The Enhanced Recovery Program (ERP) is a scientific evidence-based perioperative
      care approach based on multidisciplinary team working and multimodal methodology, with the
      aim to reduce metabolic response to surgical stress and organ dysfunction induced by surgery,
      thereby accelerating postoperative recovery. Consequently, the hospital length of stay (LOS)
      after surgery would be significantly reduced, with no increase in morbidity and mortality
      rates 2-4 resulting in a potential economic benefit.

      Although the concept of enhancing recovery after surgery implementing specific pathways is
      now widely recognized, the diffusion of ERPs is still limited to Northwestern Europe, USA,
      and Canada, and slightly less common in Southern Europe, where it prevails in Spain,
      Portugal, and Italy.

      The implementation of an ERP relies on the establishment of a motivated multidisciplinary
      team including surgeons, anesthesiologists, and nurses who agree on the end points of
      management and act in close coordination throughout the perioperative phases (outpatients
      clinic, preoperative unit, operating theater, postoperative recovery room, surgical ward). It
      has been shown that compliance to the elements of the ERP protocol correlates with clinical
      outcomes.

      The aim of this study is three-fold: 1) to investigate the impact of the colorectal ERP
      implementation in an Italian University hospital, on postoperative recovery, evaluating the
      efficacy (functional recovery, LOS), the safety (postoperative complications, 30-day
      readmission and mortality), the adherence to the protocol, the nursing workload, and the
      cost-effectiveness; 2) to assess the predictive factors of prolonged hospital LOS after
      colorectal resection; and 3) to measure patients' satisfaction in the ERP group.

      Methods A prospective series of patients (N=100) undergoing elective colorectal resection and
      completing a standardized ERP in 2013-2015 (ERP group) at the S. Anna University Hospital in
      Ferrara (Italy) will be compared to a retrospective series of patients (N=100) operated on at
      the same academic hospital in 2009-2011 (Pre-ERP group), and before the introduction of ERP
      methodology. The Italian Ministry of Health will fund this study, which will begin in January
      2013. In 2012 the ERP multidisciplinary team was built, the ERP protocol was prepared, and
      informative meetings were scheduled. All consecutive patients between the ages of 18 and 79
      years of age and scheduled for elective colorectal resection will be enrolled for the study.
      The exclusion criteria for both groups are: age >80 years old, American Society of Anesthesia
      (ASA) score IV, Tumour Node Metastasis (TNM) stage IV, inflammatory bowel disease.

      The criteria adopted for discharge of the ERP group patients are the same applied to the
      Pre-ERP group patients, specifically: 1) unrestricted oral diet, 2) full intestinal function
      recovery (i.e. passage of flatus and stool), 3) dynamic pain control (Numerical Rate Scale
      ≤3) by oral analgesia, 4) independent walking, and 5) no signs of infection.

      In order to evaluate the impact on postoperative recovery of the colorectal ERP
      implementation, the hospital LOS, a proxy of functional recovery, is adopted as a primary
      outcome. Secondary outcomes are postoperative complications, 30-day readmission and
      mortality, adherence to the protocol, nursing workload, cost-effectiveness, and the
      predictive factors of prolonged hospital LOS.

      All the data for the study will be collected prospectively for the ERP group and
      retrospectively for the Pre-ERP group.

      ERP group All patients will be extensively informed about the ERP, including discharge
      criteria and 4-day planned hospital LOS, by thorough preoperative counseling and an
      illustrated booklet specifically developed and validated by the multidisciplinary team will
      be explained and given to patients. Although laparoscopy will be preferred, the surgical
      approach will be discussed with the patient. A converted laparoscopy is defined as unplanned
      extension of the surgical incision.

      All patients in the ERP group will be encouraged during hospitalization to follow the
      perioperative protocol, and they will be informed about the objectives to be achieved on each
      day of hospital stay, including the discharge home.

      All ERP elements included in the colorectal protocol will be prospectively recorded and
      checked if successfully achieved (i.e., protocol compliance) by a detailed care program
      (daily care map) for each postoperative day (POD).

      Pre-ERP group All patients were treated following traditional perioperative care principles
      based on: 1-2) preoperative fasting since midnight with no carbohydrate loaded drinks; 3)
      opioid-based anesthesia with or without thoracic epidural; 4) postoperative pain control with
      intravenous opioids and/or thoracic epidural and/or non-steroidal anti-inflammatory drugs
      (NSAIDs); 5-6) nasogastric tube (NGT) removal and oral feeding at restoration of intestinal
      activity; 7) abdominal drain removal at bowel movements; 8) mobilization at patient's will;
      and 9) bladder catheter removal at full mobilization.

      Preoperative counseling focused on patient's training, daily goals assignment or predefined
      day of discharge were not planned.

      The medical records will be reviewed to evaluate adherence to any of the elements comprised
      in the ERP protocol and to determine how much the clinical practice has been modified by its
      implementation.

      Fulfillment of the predefined discharge criteria will be checked in both study groups, and
      outpatient appointment was scheduled at 15 and 30 days after the operation.

      The nursing workload will be evaluated using the Project Recherche Nursing (PRN), a
      standardized and validated point system based on eight groups of activities (respiration,
      feeding and hydration, elimination, hygiene, mobilization, communication, treatments,
      diagnostic procedures) that was developed in Canada to measure the level of patients' nursing
      care required. The PRN value will be compared between groups for the first few days of
      hospital stay based on the ERP patients' median LOS, the higher the point value the greater
      the amount of direct care required.

      To determine the costs-effectiveness of the ERP versus traditional care we will collect costs
      on: 1) ERP implementation; 2) preoperative phase (i.e. preoperative counseling, booklet); 3)
      direct cost of hospitalizations (i.e. operating room, drugs, exams, visits, LOS); 4)
      re-hospitalizations.

      To evaluate the patients' satisfaction, Patient Satisfaction Consultation Questionnaire
      (PSCQ-7) and the Core Questionnaire Patient Satisfaction (COPS) will be administered to all
      ERP group patients at hospital discharge.

      The study will be conducted in accordance with the principles of Helsinki Declaration, with
      approval of the medical ethics review board of the S. Anna University Hospital. A written
      informed consent will be obtained from all enrolled patients.

      Statistical analysis Data will be expressed as median (InterQuartile Range 25-75) and
      mean±standard deviation according to distribution assessed by Shapiro-Wilk test. Categorical
      data will be presented as number. Data will be analyzed using Chi-square, t-student, and
      Mann-Whitney tests as appropriate. Kaplan-Meier method has been used for analysis of surgical
      operation duration and hospital LOS. Log-Rank test has been employed to compare duration of
      surgical operation, time to functional recovery, and hospital LOS between groups. We will
      assess the association of different baseline characteristics, intraoperative variable and
      type of perioperative protocol with prolonged hospital LOS in the univariate Cox regression
      analysis adopting time to patients' hospital discharge as the endpoint of interest. For the
      time to event analyses, patients will be censored at time of hospital discharge. We will then
      calculate multivariate Cox regression analyses adjusted for potential confounders to assess
      independent predictors of prolonged hospital LOS. Of note, hazard ratios (HRs) <1 will
      correspond to an association of the factor with prolonged hospital LOS, while HRs >1
      correspond to earlier discharge. Significance will be considered for values of p <0.05.
      Statistical analysis will performed with IBM Statistics for Windows (IBM Corp.).
    

Intervention name(s): Enhanced recovery protocol
Intervention type(s): Other
Intervention description(s): Standardized enhanced recovery protocol including 21 perioperative items.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing elective colorectal resection at the S. Anna University Hospital in
        Ferrara (Italy) between 2013-2015 (ERP group) and 2009-2011 (Pre ERP group)
      
Keywords: Enhanced Recovery Program