Evaluation of the Introduction of a Colorectal Bundle inLeft Sided Colorectal Resections
- Conditions
- C18K55C20K63K57Malignant neoplasm of colonMalignant neoplasm of rectumOther diseases of intestineVascular disorders of intestineDiverticular disease of intestine
- Registration Number
- DRKS00023273
- Lead Sponsor
- Clarunis-universitäre Bauchzentrum Basel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1142
Age = 18 years
- Undergoing primary elective or emergency left sided colorectal surgery of any kind, or reoperation that is > 30 days after primary operation
- Able to provide informed consent
- Age < 18 years
- Intervention is a reoperation within 30 days of primary operation
- Additional interventions
- Unable to provide informed consent & no possibility of informed consent by proxy
- Known allergy to one of the applied antibiotic regimes within the bundle
- for antibiotic Decontamination subgroup
-- Active bacterial infection requiring systemic antibiotics
-- Received IV or oral antibiotics in past 7 days
-- Terminal kidney disease
-- Unable to take study medication (e.g. vomiting, dysphagia) at time of screening
-- Diarrhoea at time of screening
-- Pregnancy or breastfeeding
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to assess the impact of a Colorectal Bundle compared to standard care on CCI at 30-days
- Secondary Outcome Measures
Name Time Method - assess the impact of the inclusion of antibiotic decontamination into the CB in a subgroup of hospitals<br>- assess the impact of the CB protocol on SSI<br>- assess the impact of the CB protocol on mortality<br>- assess the impact of the CB hospital length of stay<br>- assess the impact of the CB on costs<br>