Tests a keyhole thyroid surgery through the collarbone area in people with thyroid tumors
Compares a keyhole collarbone-area surgery with open surgery in adults with thyroid tumors.
Plain-language title generated from the registry record
Registry title: Dual-port Trans-subclavian Thyroid Endoscopic Surgery
Key facts
- Where
- Wenzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT06398795, who can take part
Where in China
- First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First Affiliated Hospital of Wenzhou Medical University
- Trial code
- NCT06398795
- Record updated
- 31 December 2024
- Original description
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.Read full original descriptionShow less
Dual-port Trans-subclavian Thyroid Endoscopic Surgery - an Exploration of Cavity Construction in Situ Heralds a New Approach Choice
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.
Inclusion: Thyroid cancer or benign thyroid tumors; Patients with a demand for incisional cosmetic improvement.
Exclusion: Patients with thyroid cancer larger than 2 cm; Patients with severe underlying diseases; Patients with chronic kidney disease,; Patients with autoimmune diseases; benign tumors larger than 5 cm; Patients with rheumatoid arthritis.