CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Enhanced Recovery Program (ERP)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04378465
NCT04378465N/ACompleted

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

University Hospital of Ferrara·observational·Posted May 7, 2020·Updated May 7, 2020

In Brief

An observational study evaluating Enhanced Recovery Program (ERP) for Colorectal Surgery and Recovery of Function. Completed, enrolled 200 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2020
Enrollment StartJan 11, 2013
Primary CompletionDec 18, 2015
Study CompletionMay 6, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.2 years ago

Interventions

Enhanced Recovery Program (ERP)other

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