ERAS in Colorectal Surgery: Benefits of Late Adoption

Completed

• Conditions: Colorectal Disorders; Colorectal Cancer; Colorectal Neoplasms

• Registration Number: NCT05773248
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-03-06
• Study Start: 2023-03-13
• Study First Posted: 2023-03-17
• Primary Completion: 2023-03-31
• Study Completion: 2023-04-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 456

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative morbidity	30days	Postoperative complications according to the comprehensive complication index (CCI)

Secondary Outcome Measures

Name	Time	Method
Readmission rate	30 days	Rate of readmission within 30 days after the operation
Length of stay	30 days up to 3 months	Length of postoperative hospital stay (days)
Cost analysis	30 days up to 3 months	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.

Trial Locations

Locations (1)

St. Clara Hospital; 🇨🇭 Basel, Switzerland