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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Reduction of Surgical Site Infections in Colorectal Surgery

Intervention / Treatment
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* Behavioral: Bundle of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 elective or emergency colorectal surgery written informed consent Exclusion Criteria: pregnant no informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-implementation phase (October 2018 - September 2019)<br>During this time period, 137 patients underwent colorectal surgery. Only basic measures for preventing SSI were performed: Hair was removed in the operating field with a clipper instead of shaving hair. Blood glucose was monitored only during the operation. Antibiotic prophylaxis was applied 60 minutes before the operation. The application of an antibiotic prophylaxis was repeated if the operation lasted longer than 4 hours. Measures of warming were only applied during the operation and in the recovery room. Instruments and gloves were changed after finishing the anastomosis. | |
| Implementation phase (October 2019 - September 2020)<br>During this phase, additional measures have been introduced: Implementation of wound protectors during colorectal surgery. Colorectal operations were only performed with the support of an experienced consultant surgeon. | |
| Post-implementation phase (October 2020 - September 2021)<br>During this phase, additional measures are implemented. 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. 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. 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 | Behavioral: Bundle of Care<br>* Hair removal with Clipper Glucose Control Preoperative antibiotics Repeat antibiotics after 4 Hours Optimize Body temperature Instrument change for colorectal anastomosis Use of wound protectors Experienced surgeon Preoperative showering<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site infection | rate of SSIs and classification of SSIs (superficial SSI, deep SSI or organ space SSI) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for SSI | 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) | at surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal surgery, bundle of care, surgical site infection