Clinical trial NCT04552496: Cryptic Bacteria of the Thyroid Tissue as a Possible Cause of the Pathology of This Organ
Official title: The Thyroidectomy Wound Inflammation Can be Caused by Microbes Present in the Thyroid Parenchyma - Observational Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacteria Infection Mechanism
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with thyroid disease who require surgery. Preoperative clinical diagnosis: 1) non-toxic multinodular goiter, 2) toxic multinodular goiter, 3) Graves disease, 4) single adenoma, 5) Hashimoto's disease, 6) thyroid cancer and 7) recurrent thyroid disease.

Brief summary: The presence of cryptic microbes has been widely documented in animal healthy deep tissues.

The thyroid gland is an organ specifically exposed to the microbial environment due to its close location to the mouth microbiome. A number of bacterial phenotypes has been detected in the inflamed thyroid gland. A question raises as to whether bacteria have not already been present in the thyroid gland before the clinical symptoms of goiter became evident.

A problem in thyroid surgery, relatively uncommon but difficult for control, is prolonged thyroidectomy wound healing with skin flap, gland bed inflammation and fibrosis. The causative bacteria may belong to the strains persistently present in the thyroid gland parenchyma. Our objective is to answer questions: a) do the goiter tissue structures contain bacteria, b) if so, which bacterial phenotypes can be identified, c) what are the genetic similarities of the thyroid and periodontal bacterial strains.

Studies are carried out in patients with non-toxic multinodular goiter, toxic multinodular goiter, Graves' disease, single adenoma, Hashimoto's disease, thyroid cancer and recurrent thyroid disease. Tissue harvested during surgery is dissected immediately after thyroidectomy into fragments of parenchyma, arteries, veins and lymph nodes and cultured on Columbia blood agar base for up to 3 weeks. In this method bacteria present in the tissue grow in their natural environment, slowly proliferate and then form the on-plate colonies. It enables detection of even single bacteria usually difficult to be identified in planktonic media. Identification of the isolated bacteria is performed. Their DNA patterns are also compared.


Eligibility criteria: Inclusion Criteria:

* thyroid disease requiring surgery

Exclusion Criteria:

* acute or chronic infection at remote sites
* treated with antibiotics over the last 3 months

Primary outcomes:
measure: In vivo transferred to ex vivo bacteria culturing in thyroid tissue fragments. The percentage of positive bacterial growth
timeFrame: 30 days
measure: In vivo transferred to ex vivo bacteria culturing in thyroid tissue fragments. Time lapse to the first bacterial colonies appearance
timeFrame: 30 days
measure: Identification of bacterial strains isolated from cultured thyroid tissue fragments
timeFrame: 3 days
measure: Antibiotic sensitivity of bacterial strains isolated from cultured thyroid tissue fragments
timeFrame: 4 days
measure: Isolated bacteria Polymerase Chain Reaction Melting Profiles (PCR MP)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of General, Oncological and Gastrointestinal Surgery, Centre of Postgraduate Medical Education
city: Warsaw
country: Poland
facility: Department of Applied Physiology, Mossakowski Medical Research Centre, Polish Academy of Sciences
Study officials:
affiliation: Centre of Postgraduate Medical Education, Warsaw, Poland
name: Sergiusz Durowicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland
name: Marzanna Zaleska, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Clinical Hospital Ministry Interior Administration, Warsaw, Poland
name: Waldemar L. Olszewski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre of Postgraduate Medical Education, Warsaw, Poland
name: Wiesław Tarnowski, Md, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Warsaw, Warsaw, Poland
name: Ewa Swoboda-Kopeć, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: