ERAS in Colorectal Surgery: Benefits of Late Adoption

NCT ID: NCT05773248

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

456 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-13

Study Completion Date

2023-04-30

Brief Summary

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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

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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).

Conditions

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Colorectal Cancer Colorectal Neoplasms Colorectal Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard care

No interventions assigned to this group

ERAS

ERAS protocol

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Steinemann, PD Dr.

Role: STUDY_DIRECTOR

University Hospital, Basel, Switzerland

Locations

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St. Clara Hospital

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Susstrunk J, Mijnssen R, von Strauss M, Muller BP, Wilhelm A, Steinemann DC. Enhanced recovery after surgery (ERAS) in colorectal surgery: implementation is still beneficial despite modern surgical and anesthetic care. Langenbecks Arch Surg. 2023 Dec 13;409(1):5. doi: 10.1007/s00423-023-03195-7.

Reference Type DERIVED
PMID: 38091109 (View on PubMed)

Other Identifiers

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2023-00221

Identifier Type: -

Identifier Source: org_study_id

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