Dual-port Trans-subclavian Thyroid Endoscopic Surgery

Recruiting now · Not applicable

Conditions studied: Thyroid Neoplasms, Endoscopic Surgery

In brief

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.

Key facts

Study ID

NCT06398795

Run by

First Affiliated Hospital of Wenzhou Medical University

People needed

300

Starts

2022-09-01

Expected to finish

2026-12-31

Last updated by the study team

2024-12-31

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Patients with thyroid cancer larger than 2 cm
• benign tumors larger than 5 cm
• Patients with severe underlying diseases
• Patients with chronic kidney disease,
• Patients with autoimmune diseases
• Patients with rheumatoid arthritis

Where it is running

• First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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