- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05773248
ERAS in Colorectal Surgery: Benefits of Late Adoption
Implementation of an Enhanced Recovery After Surgery (ERAS) Program in Colorectal Surgery: the Benefits of Late Adoption
The aim of this single-center retrospective cohort study is to explore the effect of late adaptation of an ERAS protocol in a high-volume colorectal surgical unit.
The primary endpoint is the surgical outcome measured by early postoperative complications, defined by the comprehensive complications index. Secondary endpoints include amongst others LOS (length of stay), cost analysis, short-term follow-up in the ERAS group.
Study Overview
Status
Intervention / Treatment
Detailed Description
At Clarunis - University Center for Gastrointestinal and Liver Diseases at St. Claraspital between 2019 und 2020, all colorectal patients were treated according to a standardized perioperative protocol. As of 2021 until today, an ERAS protocol was established and all colorectal patients who met inclusion criteria participated in this program automatically as part of a new standardized care. Perioperative data was collected in a clinical information system (Phoenix - CGM Clinica Information Systeml).
In this retrospective cohort study, we compare demographic, perioperative and postoperative data among the two groups "ERAS" and "non-ERAS" using a weighted propensity score analysis for patients who underwent surgery as part of the ERAS program and for patients without a standardized ERAS protocol.
All patients treated at the colorectal unit from 2019 until August 2022 and who are considered for the analysis have given written general consent for the use of health-related data for research projects (attached to this document).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Basel, Switzerland, 4058
- St. Clara Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- written general informed consent
- patients undergoing a colorectal procedure between 2019 and August 2022 at colorectal unit, Santa Clara Hospital, Basel
Exclusion Criteria:
- All patients undergoing an emergency procedure or a combined procedure with the colorectal procedure not being the main indication for surgical treatment (i.e. gynecological debulking, liver resection, etc.) were excluded from the analysis.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Standard care
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ERAS
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The main concepts of the ERAS protocol compared to standard care included the following aspects: preoperative counselling with a specially trained nurse, restrictive use of preoperative sedation, intraoperative fluid and opioid administration and drain placement, strict antiemetic prophylaxis, early mobilisation, bowel stimulation and removal of any catheters as well as early food intake.
Additionally, the ERAS protocol included a 30-day telephone follow-up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perioperative morbidity
Time Frame: 30days
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Postoperative complications according to the comprehensive complication index (CCI)
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30days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of stay
Time Frame: 30 days up to 3 months
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Length of postoperative hospital stay (days)
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30 days up to 3 months
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Cost analysis
Time Frame: 30 days up to 3 months
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All costs and incomes for every single case is assessed to calculate the loss or revenue. This data is obtained from the in-hospital financial department. If a patient is readmitted for a complication within 30 days, the costs and incomes for the readmission is added to the case of the initial operation. |
30 days up to 3 months
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Readmission rate
Time Frame: 30 days
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Rate of readmission within 30 days after the operation
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30 days
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Collaborators and Investigators
Investigators
- Study Director: Daniel Steinemann, PD Dr., University Hospital, Basel, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-00221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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