INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery (NCT05775341) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery
Switzerland120 participantsStarted 2023-02-27
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Patients undergoing laparoscopic colorectal resection with anastomosis or patients undergoing duodeno-pancreatectomy.
* Elective surgery
* Informed consent
* Age \> 18 years
Exclusion criteria:
* Emergency surgery
* Other surgery 30 days prior to surgery
* BMI \<18 or \>50kg/m2
* Planed simultaneous second procedure with involvement of the intestinal tract
* Cholestasis with cholangitis, hepatic disease (defined as cirrhosis Child B or C) or renal disease (acute or chronic renal failure defined as eGFR≤ 30ml/min)
* Severe active enteritis or colitis, malabsorption, enteric infections
* Pancreatitis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes of the intestinal microbiome between start and end of surgery