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NCT06398795Recruiting

Dual-port Trans-subclavian Thyroid Endoscopic Surgery

Dual-port Trans-subclavian Thyroid Endoscopic Surgery - an Exploration of Cavity Construction in Situ Heralds a New Approach Choice

Source: ClinicalTrials.gov · Last updated 31 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is a prospective, single-center, open-label, non-randomized controlled real-world study aimed at exploring a novel approach to cavity construction for thyroid endoscopic surgery. The study seeks to evaluate its effectiveness and safety while accumulating further evidence-based medical data. Three hundred patients with thyroid tumors were divided into an experimental group (150 cases receiving a new endoscopic thyroid surgery technique, namely, dual-port trans-subclavian thyroid endoscopic surgery) and a control group (150 cases undergoing traditional open thyroid surgery) according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events are recorded detailly. The primary efficacy endpoint is a comparison of surgical complications between the two treatment groups. Secondary endpoints include: (1) levels of IL-2, IL-4, IL-6, IL-10, TNF-α, INF-γ, renin, angiotensin II, and aldosterone preoperatively and on the second day postoperatively; (2) NRS scores on the first day postoperatively; (3) length of hospital stay, duration of surgery, total treatment cost, and postoperative drainage volume; and (4) assessment of wound satisfaction during a three-month follow-up visit. Safety assessments include adverse events, vital signs, and pathological examinations.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
300 (estimated)
First submitted
22 Apr 2024
Start date
1 Sept 2022
Primary completion date
31 Dec 2026
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
NCT number
NCT06398795

What you commit to

  • Study type: Interventional
  • Planned participants: 300
  • From 1 Sept 2022 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with thyroid cancer larger than 2 cm
  • Patients with severe underlying diseases
  • Patients with chronic kidney disease,
  • Patients with autoimmune diseases

Other

  • benign tumors larger than 5 cm
  • Patients with rheumatoid arthritis

Who the study is looking for

  • Thyroid cancer or benign thyroid tumors
  • Patients with a demand for incisional cosmetic improvement

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
First Affiliated Hospital of Wenzhou Medical University
Coordinator of this site? Confirm its status
WenzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.