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Enhanced Recovery Program in Laparoscopic Colorectal Surgery: an Observational Controlled Trial

NCT04378465 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-05-07

No results posted yet for this study

Summary

Background: A few randomized clinical trials and meta-analysis provide evidence for enhanced recovery programs (ERPs) in colorectal surgery. Most of the evidence, however, relies on non-randomized controlled studies that have control groups being either historical or operated on at different facilities. The aim of this study was to compare a prospective series of patients undergoing elective colorectal surgery according to ERPs, with a coeval retrospective series of patients undergoing elective colorectal surgery in a different ward at the same hospital.

The primary outcome was hospital length of stay, which was used as a proxy of functional recovery. Secondary outcomes included: postoperative complications, readmission rate, mortality, and adherence to the protocol.

Materials and Methods: A prospective series of consecutive patients (N = 100) undergoing elective colorectal resection completing a standardized ERP in 2013-2015 (ERP Group) will be compared to patients (N = 100) operated at the same institution in the same period with a traditional perioperative care protocol (Non-ERP group). Despite different surgeons and ward nurses, the two groups shared the same anaesthesiologists and were located in separate wards. The exclusion criteria were: \>80 years old, ASA score of IV, a stage IV TNM, and diagnosis of inflammatory bowel disease.

Conditions

  • Colorectal Surgery
  • Recovery of Function

Interventions

OTHER

Enhanced Recovery Program (ERP)

An evidence-based perioperative care approach, involving a multidisciplinary team work including surgeons, anaesthesiologists, dieticians, and nurses, which aim to reduce the surgical stress and metabolic responses as well as organ dysfunction, thus leading to a faster recovery after surgery

Sponsors & Collaborators

  • University Hospital of Ferrara

    lead OTHER

Principal Investigators

  • Carlo V Feo, MD · University Hospital of Ferrara, Italy

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
2019-05-06

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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 NCT04378465 on ClinicalTrials.gov