Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775341
Status:
RECRUITING
Last Update Posted:
2023-11-24
First Post:
2023-03-07
Brief Title:
INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Analysis of INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Abdominal Surgery
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTRA
Brief Summary:
The goal of this observational study is to contribute to a better understanding of the perioperative kinetics of intestinal microbial composition and association with surgical site infections
The main question this study aims to determine if
Patients undergoing surgery develop transient intestinal dysbiosis
Such transient dysbiosis is associated with translocation to the systemic circulation and surgical site infection
Patients undergoing elective abdominal surgery will be included prospectively Informed consent will be obtained From patients the following information and samples will be collected
Perioperative Baseline health data nutrition data measurement body composition glucose monitoring
Intraoperatively
Mucosal swabs
Blood from central venous catheter and portal vein
Mesenteric lymph node
Intestinal specimen
Bile
Subcutaneous biopsy
Postoperatively
If a surgical site infection occurs samples from infected site
The main question this study aims to determine if
Patients undergoing surgery develop transient intestinal dysbiosis
Such transient dysbiosis is associated with translocation to the systemic circulation and surgical site infection
Patients undergoing elective abdominal surgery will be included prospectively Informed consent will be obtained From patients the following information and samples will be collected
Perioperative Baseline health data nutrition data measurement body composition glucose monitoring
Intraoperatively
Mucosal swabs
Blood from central venous catheter and portal vein
Mesenteric lymph node
Intestinal specimen
Bile
Subcutaneous biopsy
Postoperatively
If a surgical site infection occurs samples from infected site
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None