Clinical trial

Analysis of Mechanism on the Efficacy of Oral Antibiotic Prophylaxis in Elective Colon and Rectal Surgery With Primary Anastomosis

Name
Surgi-Comics_01
Description
The microbiome, the collection of microorganisms that live in our gut, plays an important role in maintaining our health, proper nutrient absorption, nutrient turnover and immunity. After birth, a symbiotic relationship develops with the strains of bacteria that colonise our gut, and the presence and proportion of bacteria is individualised and highly variable. A healthy bacterial flora is essential for the cells of the intestinal mucosa. Glycoproteins in the cell surface mucus coat are important nutrients for bacteria, while some bacterial strains supply mucosal cells with nutrient molecules (e.g. short-chain fatty acids) that are their essential energy source. An abnormal change in the proportion of bacterial strains that make up the microbiome, dysbacteriosis, in which pathogenic bacteria proliferate at the expense of members of the normal flora, can cause a number of pathologies. Nutrient supply to the cells of the mucosa is reduced, making them more vulnerable and leading to various pathological conditions. The microbiome and the essential nutrients they produce have also been found to play an important role in wound healing. A decrease in the diversity of the microbiome, an increase in the relative number of pathogenic bacteria and a decrease in the proportion of 'beneficial' bacteria increases the risk of surgical complications of infection and suture failure.
Trial arms
Trial start
2023-02-01
Estimated PCD
2025-01-31
Trial end
2026-01-31
Status
Recruiting
Treatment
Neomycin Sulfate
Postoperative day-1 Oral Antibiotic Prophylaxis + patients get po. 3x1000mg Neomycin sulfate and 3x500 mg Metronidazole
Arms:
Oral Antibiotic Prophylaxis +
Other names:
Metronidazole
Size
100
Primary endpoint
Microbiome
postoperative 30 days
Eligibility criteria
Inclusion Criteria: * Circular stapled anastomosis * Planned surgery with colo-colic anastomosis * No passage disorder, as it is confirmed at the first medical examination * Not allergic to antibiotics * Can receive a bowel preparation * No proximal excluded intestine, i.e., the bowel preparation may be successful (ileostomy) Exclusion Criteria: * treated with antibiotics within 2 weeks before randomisation * allergic to any of the medicines used * under 18 years of age * have suffered from abdominal sepsis within 6 months prior to recruitment * pregnancy or breastfeeding * been treated with steroids * any form of chronic immunosuppression
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Anastomotic ring full thickness colonic wall'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-03-22

1 organization

1 product

2 indications

Organization
Uzsoki Hospital
Product
Neomycin