Observation of the Implementation of a Bundle of Care in Colorectal Surgery to Reduce Surgical Site Infections Successfully

• Conditions: Reduction of Surgical Site Infections in Colorectal Surgery
• Interventions: Behavioral: Bundle of Care

• Registration Number: NCT04677686
• Lead Sponsor: Luzerner Kantonsspital

Brief Summary

This study aims to evaluate whether the colorectal bundle designed and implemented at Cantonal Hospital Lucerne, will lead to a significant reduction of SSIs. The impact of potential risk factors for SSIs will additionally be evaluated.

Detailed Description

Surgical site infections (SSIs) remain a relevant problem in colorectal surgery. The aim of this study is to implement a bundle of care in order to reduce SSIs in colorectal surgery.

All patients undergoing colorectal surgery between October 2018 and September 2021 will be included in a prospective observational study. Since our colorectal bundle has been established gradually, patients will be grouped in a pre-implementation (2018-2019), implementation (2019-2020) and post implementation phase (2020-2021), in order to assess the effectiveness of the actions undertaken. Primary endpoint of this study will be surgical site infection (SSI) rate, while secondary endpoints encompass potential risk factors for SSIs. We assume that obesity, age, diabetes, alcoholism and smoking may lead to a higher risk for SSIs.

Study Timeline

• Study Start: 2020-10-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-16
• Last Update Submitted: 2020-12-16
• Study First Posted: 2020-12-21
• Last Update Posted: 2020-12-21
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

over 18 elective or emergency colorectal surgery written informed consent

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Exclusion Criteria

pregnant no informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-implementation phase (October 2020 - September 2021)	Bundle of Care	During this phase, additional measures are implemented. 1. Close monitoring of blood glucose. During the stay in the recovery room and for 48 hours post-operative, blood glucose is monitored closely. Moreover, if blood glucose is higher than 9 mmol/l, the patient will be treated with insulin. This measure is applied to diabetic as well as to non-diabetic-patients. 2. The measures of warming will be intensified. First of all, during the operation and during the stay in the recovery room patients will be placed on warming mattresses. Moreover, a warming towel will be placed on the operating field directly after the operation. 3. The patients will be asked to take a shower the night before surgery. In case of an emergency operation, patients will be asked to wash the axilla, trunk, genitalia, groins and umbilicus

Primary Outcome Measures

Name	Time	Method
Surgical Site infection	30 days	rate of SSIs and classification of SSIs (superficial SSI, deep SSI or organ space SSI)

Secondary Outcome Measures

Name	Time	Method
Risk factors for SSI	at surgery	Determination of the risk factors for SSI (Obesity, age, diabetes, alcoholism, immune-deficit illnesses (such as HIV and Hepatitis), smoking, immunosuppressive drugs, chemotherapy, radiotherapy, COPD, pAVK, renal insufficiency and poor Nutrition)

Trial Locations

Locations (1)

Cantonal Hospital of Lucerne; 🇨🇭 Lucerne, Switzerland