Dual-port Trans-subclavian Thyroid Endoscopic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorFirst Affiliated Hospital of Wenzhou Medical University
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS).
Procedure/SurgeryAn innovative surgical approach, Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS), presents a unique dual-port endoscopic technique for thyroidectomy. DTS significantly reduces postoperative hospital stay, emphasizing its potential for accelerated patient recovery compared to COT.
Conventional open thyroidectomy (COT)
Procedure/Surgeryopen thyroidectomy with traditional collar incisions
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: DTS groupExperimental treatment 1 intervention
Group B: COT groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of postoperative complications
The incidence of postoperative complications including recurrent laryngeal nerve injury, hypoparathyroidism, chyle leakage, infection and so on.
Time frame
From the date of grouping to the first recorded progression of relapse or the date of death due to any cause, whichever came first, assessed up to 100 months.Sponsors and contacts
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Source ClinicalTrials.gov