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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04677686
Enrollment
150
Registered
2020-12-21
Start date
2020-10-01
Completion date
2021-09-30
Last updated
2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduction of Surgical Site Infections in Colorectal Surgery

Keywords

colorectal surgery, bundle of care, surgical site infection

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.

Interventions

BEHAVIORALBundle 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

Sponsors

Luzerner Kantonsspital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

over 18 elective or emergency colorectal surgery written informed consent

Exclusion criteria

pregnant no informed consent

Design outcomes

Primary

MeasureTime frameDescription
Surgical Site infection30 daysrate of SSIs and classification of SSIs (superficial SSI, deep SSI or organ space SSI)

Secondary

MeasureTime frameDescription
Risk factors for SSIat surgeryDetermination 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)

Countries

Switzerland

Contacts

Primary ContactJörn-Markus Gass
markus.gass@luks.ch0041412854835

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026