Patients undergoing open pancreaticoduodenectomy or open colon-/ rectum resection for any indication (not inevitable cancer patients)
Conditions
Interventions
Group 1: There will be extensive biospecimen collection at various fixed time points (baseline, surgery, post-surgery, D14, D30, D90) and a maximum of 3 different clinical events (CEV 1-3).
Sponsors
Universitätsklinikum Frankfurt
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Planned open/laparoscopic surgery that involves opening of the abdominal cavity for any indication 3. Patient able to provide required baseline samples at a maximum of 14 days prior to the surgical procedure 4. Written informed consent provided prior to inclusion
Exclusion criteria
Exclusion criteria: 1. Patient with any social or logistical condition which in the opinion of the investigator may interfere with the conduct of the study, such as incapacity to well understand, not willing to collaborate, or cannot easily be contacted after discharge 2. Previous participation in this study 3. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association of antibiotic exposure with emergence of MDRO colonization and infection at day 30 following intra-abdominal surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary and exploratory endpoints: Surgery and infection-associated secondary and exploratory endpoints: • Incidence of 30/ 90 day rates of infections (MI/CI target infections, any MI/CI infection; please find definitions below) • Correlation of cumulative antibiotic exposure on emergence of MDRO colonization and infection at day 30 following intra-abdominal surgery • Proportion of MI infections involving at least one endogenous pathogen identified as dominating the respective microbiota composition in a preceding study sample • Impact of patient management standards on 30/90 day rates of infections (MI/CI target infections, any MI/CI infection) • Impact of inappropriate anti-infective prescription compared to adequate or no anti-infective prescription on 30/90 day rates of infections (MI/CI target infections, any MI/CI infection) • Incidence of 30/90 day complications (death, new/prolonged ventilation, surgical revision) • Long-term assessment of patient quality of live following complex intra-abdominal surgery (at baseline, 30/90 days, 6 months, 1 year and 2 years following surgery) • Association of changes in the microbiota composition with oncological outcomes (disease free survival, overall survival, recurrence) • Development of a model predicting infectious complications (MI/CI target infections, any MI/CI infection) and emergence of MDRO colonization Microbiota-associated secondary and exploratory endpoints: • Identification of distinct microbiota signatures that confer resilience to colonization with MDRO • Identification of specific microbiota compositions including dominance by a specific taxon that precedes infection • Changes in alpha diversity levels of the intestinal microbiota during observational period • Influence of patient management standards on intestinal microbiota composition and emergence of MDRO colonization • Influence of inappropriate anti-infective prescription versus adequate or no anti-infective prescription on intes | — |
Countries
Germany
Contacts
Public ContactMaria J.G.T. Vehreschild
Universitätsklinikum Frankfurt
Outcome results
None listed