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Study on the migration of bacteria in transoral endoscopic thyroidectomy vestibular approach (TOETVA) and develop a comprehensive oral management process

Study on the migration of bacteria in transoral endoscopic thyroidectomy vestibular approach (TOETVA) and develop a comprehensive oral management process

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122005
Enrollment
Unknown
Registered
2026-04-08
Start date
2025-03-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid tumor

Interventions

O Group (Open Surgery):Traditional open thyroid surgery
A Group (Pre-op Cefoxitin):TOETVA surgery with preoperative prophylactic cefoxitin
B1 Group (TOETVA Pre-op No Antibiotic, Day 0):TOETVA surgery without preoperative antibiotics, immediate postoperative drainage fluid on day 0
B2 Group (TOETVA Post-op Cefoxitin Day 1):TOETVA surgery with postoperative cefoxitin, morning drainage fluid on day 1
B3 Group (TOETVA Post-op Cefoxitin Day 2):TOETVA surgery with postoperative cefoxitin, morning drainage fluid on day 2
C1 Group (TOETVA Pre-op No Antibiotic, Day 0 - Metronidazole):TOETVA surgery without preoperative antibiotics, immediate postoperative drainage fluid on day 0 (metronidazole group)
C2 Group (TOETVA Post-op Metronidazole Day 1):TOETVA surgery with postoperative metronidazole sodium chloride, morning drainage fluid on day 1
C3 Group (TOETVA Post-op Metronidazole Day 2):TOETVA surgery with postoperative metronidazole sodium chloride, morning drainage fluid on day 2
CI Group (Pre-op Skin Disinfection):III-type iodine skin disinfection at submental area before TOETVA surgery followed by swab sampling
N Group (Pre-op NaCl Rinsing):0.9% NaCl rinsing at oral vestibule before TOETVA surgery followed by swab sampling
M Group (Pre-op Mouthwash Rinsing):Mouthwash rinsing at oral vestibule before TOETVA surgery followed by swab sampling
TD Group (Pre-op Metronidazole Rinsing):Concentrated tinidazole rinsing at oral vestibule before TOETVA surgery followed by swab sampling
VI Group (Pre-op Iodine Rinsing):III-type iodine rinsing at oral vestibule before TOETVA surgery followed by swab sampling
Pus Group (Infection Pus):Pus from infected wound (bacterial culture and drug sensitivity test)

Sponsors

The First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Thyroid surgery patients who meet the TOETVA surgical indications, patients who undergo intraoral endoscopic thyroid surgery with the same surgeon, and patients who undergo open thyroid surgery; 2. The maximum surgical scope is bilateral total thyroidectomy+bilateral central lymph node dissection; 3. The operation time is less than 4 hours

Exclusion criteria

Exclusion criteria: Except for TOETVA contraindications, patients who experience other site infections during the perioperative period and use antibiotics, those who do not plan to undergo another surgery, and those who have switched to open endoscopy.

Design outcomes

Primary

MeasureTime frame
Dominant bacterial species and abundance in drainage fluid;Bacterial DNA concentration in drainage fluid;Dominant bacterial species and abundance in vestibular oral mucosa;Pathogenic bacterial species and antimicrobial susceptibility results in infected cases;Safety outcomes (including postoperative infection rate, adverse events, pathogenic bacterial species and antimicrobial susceptibility results in infected cases);

Countries

China

Contacts

Public ContactCheng Ruochuan

The First Affiliated Hospital of Kunming Medical University

cruochuan@foxmail.com+86 137 0846 7986

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 29, 2026