Observation of the Implementation of a Bundle of Care in Colorectal Surgery to Reduce Surgical Site Infections Successfully
NCT ID: NCT04677686
Last Updated: 2020-12-21
Study Results
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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UNKNOWN
150 participants
OBSERVATIONAL
2020-10-01
2021-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Pre-implementation phase (October 2018 - September 2019)
During this time period, 137 patients underwent colorectal surgery. Only basic measures for preventing SSI were performed:
1. Hair was removed in the operating field with a clipper instead of shaving hair.
2. Blood glucose was monitored only during the operation.
3. Antibiotic prophylaxis was applied 60 minutes before the operation.
4. The application of an antibiotic prophylaxis was repeated if the operation lasted longer than 4 hours.
5. Measures of warming were only applied during the operation and in the recovery room.
6. Instruments and gloves were changed after finishing the anastomosis.
No interventions assigned to this group
Implementation phase (October 2019 - September 2020)
During this phase, additional measures have been introduced:
1. Implementation of wound protectors during colorectal surgery.
2. Colorectal operations were only performed with the support of an experienced consultant surgeon.
No interventions assigned to this group
Post-implementation phase (October 2020 - September 2021)
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
Bundle of Care
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
Interventions
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Bundle of Care
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Luzerner Kantonsspital
OTHER
Responsible Party
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Principal Investigators
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Jörn-Markus Gass
Role: PRINCIPAL_INVESTIGATOR
Cantonal Hospital of Lucerne, Spitalstrasse, 6000 Lucerne 16
Locations
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Cantonal Hospital of Lucerne
Lucerne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Jörn-Markus Gass
Role: primary
References
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Brunner S, Liesenberg J, Fourie L, Metzger J, Scheiwiller A, Zschokke I, Lehnick D, Gass JM. Implementation of a Bundle of Care in Colorectal Surgery to Reduce Surgical Site Infections Successfully at Cantonal Hospital Lucerne: Study Protocol for a Prospective Observational Study. Int J Surg Protoc. 2021 Sep 23;25(1):220-226. doi: 10.29337/ijsp.150. eCollection 2021.
Other Identifiers
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220-00051
Identifier Type: -
Identifier Source: org_study_id