Surgical Site InfectionINTRANCT05775341
INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery
An observational study of Surgical Site Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Feb 2023to 31 Dec 2026
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective abdominal surgery
Who may be able to join
- Patients undergoing laparoscopic colorectal resection with anastomosis or patients undergoing duodeno-pancreatectomy.
- Elective surgery
- Informed consent
- Age > 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Abdominal 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:
Read more
- 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
- Conditions
- Surgical Site Infection
- Being tested
- No Intervention
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is purely an observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the intestinal microbiome between start and end 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.
Measured: Day 0 (Day of Surgery)
Secondary outcomes (4)
Bacterial taxonomy in the intestine
Bacterial taxonomy in the intestine at start (T1) and end (T2) of surgery
Measured: Day 0 (Day of Surgery)
Bacterial taxonomy MLN
Bacterial taxonomy MLN end (T2) of surgery
Measured: Day 0 (Day of Surgery)
Bacterial taxonomy mucosal swabs
Bacterial taxonomy mucosal swabs at start (T1) and end (T2) of surgery
Measured: Day 0 (Day of Surgery)
Bacterial taxonomy in the blood
Bacterial taxonomy in the blood at start (T1) and end (T2) of surgery
Measured: Day 0 (Day of Surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start27 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Beldi, Principal investigator, Department of Visceral Surgery and Medicine, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775341
- Sponsor's protocol ID
- 2022-01054
- Acronym
- INTRA
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05775341
- Acronym / sponsor ID
- INTRA / 2022-01054
- Conditions
- Surgical Site Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective abdominal surgery
Key inclusion criteria (4 listed)
- Patients undergoing laparoscopic colorectal resection with anastomosis or patients undergoing duodeno-pancreatectomy.
- Elective surgery
- Informed consent
- Age > 18 years
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is purely an observational study. | Other | – |
Primary outcome
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.
4 secondary outcomes
Bacterial taxonomy in the intestine
Time frame: Day 0 (Day of Surgery)
Bacterial taxonomy MLN
Time frame: Day 0 (Day of Surgery)
Bacterial taxonomy mucosal swabs
Time frame: Day 0 (Day of Surgery)
Bacterial taxonomy in the blood
Time frame: Day 0 (Day of Surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Beldi principal investigator
Department of Visceral Surgery and Medicine, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the intestinal microbiome between start and end of surgery (time frame: Day 0 (Day of Surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.