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: Completed
• Conditions: Colorectal Neoplasms; Colorectal Cancer; Colorectal Disorders
• Intervention / Treatment: Procedure: ERAS protocol

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: Observational
• Enrollment (Actual): 456

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4058
    • St. Clara Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing a colorectal procedure between 2019 and August 2022 at colorectal unit, Santa Clara Hospital, Basel

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard care
ERAS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative morbidity	Postoperative complications according to the comprehensive complication index (CCI)	30days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Length of postoperative hospital stay (days)	30 days up to 3 months
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
Readmission rate	Rate of readmission within 30 days after the operation	30 days

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Director: Daniel Steinemann, PD Dr., University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2023-00221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently, there is no plan to shared IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No