ERAS in Colorectal Surgery: Benefits of Late Adoption

Colorectal Cancer Clinical Trial

Official title:

Implementation of an Enhanced Recovery After Surgery (ERAS) Program in Colorectal Surgery: the Benefits of Late Adoption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05773248
• Other study ID #: 2023-00221
• Status: Completed
• Start date: March 13, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: April 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Disorders
• Colorectal Neoplasms

Intervention

Procedure:
• ERAS protocol
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.

Locations

Country	Name	City	State
Switzerland	St. Clara Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative morbidity	Postoperative complications according to the comprehensive complication index (CCI)	30days
Secondary	Length of stay	Length of postoperative hospital stay (days)	30 days up to 3 months
Secondary	Cost analysis	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
Secondary	Readmission rate	Rate of readmission within 30 days after the operation	30 days