INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery

Surgical Site Infection Clinical Trial

— INTRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05775341
• Other study ID #: 2022-01054
• Status: Recruiting
• Start date: February 27, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Guido Beldi, MD, Prof
• Phone: +41 31 632 48 18
• Email: guido.beldi[@]insel.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysbiosis
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Other:
• No Intervention
This is purely an observational study.

Locations

Country	Name	City	State
Switzerland	Beldi Guido	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 (Day of Surgery)
Secondary	Bacterial taxonomy in the intestine	Bacterial taxonomy in the intestine at start (T1) and end (T2) of surgery	Day 0 (Day of Surgery)
Secondary	Bacterial taxonomy MLN	Bacterial taxonomy MLN end (T2) of surgery	Day 0 (Day of Surgery)
Secondary	Bacterial taxonomy mucosal swabs	Bacterial taxonomy mucosal swabs at start (T1) and end (T2) of surgery	Day 0 (Day of Surgery)
Secondary	Bacterial taxonomy in the blood	Bacterial taxonomy in the blood at start (T1) and end (T2) of surgery	Day 0 (Day of Surgery)