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NCT Number: NCT05773248

ERAS in Colorectal Surgery: 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Disorders Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Clara Hospital

Basel, 4058, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ERAS protocol

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.

Primary outcomes

  1. Perioperative morbidity

    Time frame: 30days

    Postoperative complications according to the comprehensive complication index (CCI)

Secondary outcomes

  1. Length of stay

    Time frame: 30 days up to 3 months

    Length of postoperative hospital stay (days)

  2. Cost analysis

    Time frame: 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.

  3. Readmission rate

    Time frame: 30 days

    Rate of readmission within 30 days after the operation

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2023
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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