Understanding gut bacteria changes in surgery patients
Analysis of INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Abdominal Surgery
Insel Gruppe AG, University Hospital Bern · NCT05775341
This study looks at how gut bacteria change in patients having abdominal surgery to see if these changes are linked to the risk of infections after the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT05775341 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the changes in intestinal microbial composition in patients undergoing elective abdominal surgery and how these changes may relate to the occurrence of surgical site infections. It will collect various health data and biological samples from patients before, during, and after surgery to analyze the relationship between transient intestinal dysbiosis and infection risk. The study will focus on patients undergoing laparoscopic colorectal resection or duodeno-pancreatectomy, gathering comprehensive perioperative data to enhance understanding of microbial dynamics in surgical contexts.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old scheduled for elective laparoscopic colorectal resection or duodeno-pancreatectomy.
Not a fit: Patients undergoing emergency surgery or those with significant comorbidities affecting gut health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing surgical site infections in patients undergoing abdominal surgery.
How similar studies have performed: While the specific approach of this study is observational and may be novel, similar studies have shown that understanding gut microbiota can influence infection outcomes in surgical patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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 colorectal 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
Where this trial is running
Bern
- Beldi Guido — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Guido Beldi — Department of Visceral Surgery and Medicine, Bern University Hospital
- Study coordinator: Guido Beldi, MD, Prof
- Email: guido.beldi@insel.ch
- Phone: +41 31 632 48 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Surgical Site Infection