The Inselspital Surgical Cohort Study

Surgical Site Infection Clinical Trial

— InSurg  

Official title:

The Inselspital Surgical Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04096885
• Other study ID #: 2019-00576
• Status: Active, not recruiting
• Start date: September 9, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Personalizing surgical care is of enormous clinical relevance, when considering the number of patients undergoing surgery in Switzerland every year. Currently, personalization is based on underlying or coexisting disease or alterations of laboratory values, but there is no accepted biological test available that may predict success or failure of surgery. Surgical site infections are the most common form of hospital-acquired infections. While the relevance of bacteria, antibiotics and intensive care support is well accepted, the impact of the individual host response remains poorly understood. The Investigators hypothesize that postoperative alterations of the metabolome allow identification of predictors of surgical complications in general, and surgical site infections in particular.

Description:

The investigators will conduct a prospective cohort study aiming to identify the metabolic and genetic signature that is associated with surgical site infections. Secondary aims and outcomes include the influence of metabolome on response to anesthetic drugs and acute and chronic pain, surgery- and anesthesia-factors related to short- and long-term oncological outcome, metabolic response effect on infectious complications and rejection after transplantation, bacteria-specific immune responses to major surgery after 2-4 weeks after surgery, metabolomics and macrobiotic markers for postoperative ileus or anastomotic leakage, and the effect of the presence of multidrug resistant bacteria on surgical outcome. All patients undergoing surgery in the investigators' clinic and who gave informed consent will be included. A blood sample will be taken before surgery, on the first postoperative day and after 3-8 weeks. A Urine sample will be taken after surgery and after 3-8 weeks. Sink and rectal swabs will be acquired before surgery. The samples will be stored in a Biobank. Additionally, all data routinely captured during the treatment of the patient from the different data collection systems in use in the investigators' hospital will be coded and centralized in a single, cohort database

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing surgery at the Department of Visceral Surgery and Medicine, Inselspital, University Hospital Bern
• Who gave General consent
• Study-specific written informed consent

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

Diagnostic Test:
• Blood and urine samples, skin and stool swabs
Blood samples will be collected before surgery, on the first postoperative day and after 3-8 weeks. Urine samples will be collected after surgery and after 3-8 weeks. Stool and skin swabs will be collected before surgery.

Locations

Country	Name	City	State
Switzerland	Beldi Guido	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraoperative metabolomic Response to surgery	Metabolome will be extracted from the blood, skin, urine and stool samples analyzed using high resolution mass spectrometry. Metabolomic analysis will be obtained preoperatively in the outpatient setting (elective patients) or at the beginning (emergency patients) and end of the operation. Patterns of metabolites will be evaluated by untargeted analysis.	8 weeks
Other	Disease-free survival after surgery	Disease-free survival after surgery in years will be recorded in oncological patients, and interpreted according to surgical and anesthesia-specific responses after abdominal surgery, in terms of metabolomics analysis of the blood, skin, urine and stool samples, as described above.	3 years
Other	Recurrence-free survival after surgery	Recurrence-free survival after surgery in years will be recorded in oncological patients, and interpreted according to surgical and anesthesia-specific responses after abdominal surgery, in terms of metabolomics analysis of the blood, skin, urine and stool samples, as described above.	3 years
Other	Overall survival after surgery	Overall survival after surgery in years will be recorded in oncological patients, and interpreted according to surgical and anesthesia-specific responses after abdominal surgery, in terms of metabolomics analysis of the blood, skin, urine and stool samples, as described above.	3 years
Primary	Incidence of surgical site infection	Number of patients with surgical site infections 30 days postoperatively	30 days
Secondary	Stool - incidence of surgical site infections	Predictive value of preoperative stool sample for surgical site infections	30 days
Secondary	Urine - incidence of surgical site infections	Predictive value of preoperative urine sample for surgical site infections	30 days
Secondary	Blood - incidence of surgical site infections	Predictive value of pre and postoperative plasma metabolome for surgical site infections	30 days
Secondary	Somatic genomic in surgical site infections	Predictive value of somatic genomic variations for surgical site infections	30 days
Secondary	Informed Consent	Rate of inclusion for informed consenting	3 years
Secondary	Biobanking	Rate of inclusion for full biobanking	3 years