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Impact of a Colorectal Enhanced Recovery Program Implementation on Clinical Outcomes and Institutional Costs

NCT03382210 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2017-12-22

No results posted yet for this study

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.

Conditions

  • Colorectal Surgery
  • Recovery of Function
  • Laparoscopic Surgery

Interventions

OTHER

Enhanced recovery protocol

Standardized enhanced recovery protocol including 21 perioperative items.

Sponsors & Collaborators

  • Ministero della Salute, Italy

    collaborator OTHER

  • Università degli Studi di Ferrara

    collaborator OTHER

  • University Hospital of Ferrara

    lead OTHER

Principal Investigators

  • Carlo V Feo, MD · University Hospital Ferrara

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-11
Primary Completion
2015-12-18
Completion
2016-04-11

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03382210 on ClinicalTrials.gov