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The Inselspital Surgical Cohort Study (InSurg)

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ClinicalTrials.gov Identifier: NCT04096885
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief 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.

Condition or disease Intervention/treatment
Surgical Site Infection Diagnostic Test: Blood and urine samples, skin and stool swabs

Detailed 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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: The Inselspital Surgical Cohort Study
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : September 9, 2022
Estimated Study Completion Date : September 9, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
InSurg cohort
Patients who undergo elective or emergency surgery at the Department of Visceral Surgery and Medicine, Inselspital, Bern, who gave informed consent.
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.




Primary Outcome Measures :
  1. Incidence of surgical site infection [ Time Frame: 30 days ]
    Number of patients with surgical site infections 30 days postoperatively


Secondary Outcome Measures :
  1. Stool - incidence of surgical site infections [ Time Frame: 30 days ]
    Predictive value of preoperative stool sample for surgical site infections

  2. Urine - incidence of surgical site infections [ Time Frame: 30 days ]
    Predictive value of preoperative urine sample for surgical site infections

  3. Blood - incidence of surgical site infections [ Time Frame: 30 days ]
    Predictive value of pre and postoperative plasma metabolome for surgical site infections

  4. Somatic genomic in surgical site infections [ Time Frame: 30 days ]
    Predictive value of somatic genomic variations for surgical site infections

  5. Informed Consent [ Time Frame: 3 years ]
    Rate of inclusion for informed consenting

  6. Biobanking [ Time Frame: 3 years ]
    Rate of inclusion for full biobanking


Other Outcome Measures:
  1. Intraoperative metabolomic Response to surgery [ Time Frame: 8 weeks ]
    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.

  2. Disease-free survival after surgery [ Time Frame: 3 years ]
    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. Recurrence-free survival after surgery [ Time Frame: 3 years ]
    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.

  4. Overall survival after surgery [ Time Frame: 3 years ]
    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.


Biospecimen Retention:   Samples With DNA
Blood, urine and stool samples pre- and post-operative for microbiota, genomic and metabolomic analysis


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing surgery at the Department of Visceral Surgery and Medicine, Inselspital, University Hospital Bern
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096885


Contacts
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Contact: Guido Beldi 031 632 82 75 Guido.Beldi@insel.ch

Locations
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Switzerland
Beldi Guido Recruiting
Bern, Switzerland, 3010
Contact: Beldi Guido    +41316322326    guido.beldi@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Guido Beldi University Hospital Inselspital, Berne

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04096885     History of Changes
Other Study ID Numbers: 2019-00576
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
cohort
visceral surgery
biobank
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes