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NCT Number: NCT05775341

INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beldi Guido

Bern, 3008, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This is purely an observational study.

Primary outcomes

  1. Changes of the intestinal microbiome between start and end of surgery

    Time frame: Day 0 (Day of Surgery)

    Score between PCA (principal components analysis) in the intestine between start (T1) and end (T2) of surgery.

    • Sampling: An intestinal specimen is dissected at start and end of elective pancreatic resections.
    • Processing: Samples are immediately processed for storage at -80° in glycerol.
    • Analysis: Quantification of total Biomass, DNA extraction, preparation of Bacterial DNA libraries, sequencing with Illumina system, downstream analysis, statistical analysis, principal components analysis (PCA) with all the samples is performed and the score is defined based on the distance between the two centers in PC1 and PC2 of T1 versus T2.

Secondary outcomes

  1. Bacterial taxonomy in the intestine

    Time frame: Day 0 (Day of Surgery)

    Bacterial taxonomy in the intestine at start (T1) and end (T2) of surgery

  2. Bacterial taxonomy MLN

    Time frame: Day 0 (Day of Surgery)

    Bacterial taxonomy MLN end (T2) of surgery

  3. Bacterial taxonomy mucosal swabs

    Time frame: Day 0 (Day of Surgery)

    Bacterial taxonomy mucosal swabs at start (T1) and end (T2) of surgery

  4. Bacterial taxonomy in the blood

    Time frame: Day 0 (Day of Surgery)

    Bacterial taxonomy in the blood at start (T1) and end (T2) of surgery

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Analysis of INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Abdominal Surgery

Acronym: INTRA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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