About this trial
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.
Eligibility criteria
Qualifiers
Thyroid cancer or benign thyroid tumors
Patients with a demand for incisional cosmetic improvement
Disqualifiers
Patients with thyroid cancer larger than 2 cm
benign tumors larger than 5 cm
Patients with severe underlying diseases
Patients with chronic kidney disease,
Trial design
Treatments tested in this trial
- Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS).
- Conventional open thyroidectomy (COT)