INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery (INTRA)

Insel Gruppe AG, University Hospital Bern

Status: Active, not recruiting

Conditions: Surgical Site Infection

Treatments: Other: No Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05775341

2022-01054

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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