Actively Recruiting
Dual-port Trans-subclavian Thyroid Endoscopic Surgery An Evaluation of a New Approach Compared to Conventional Open Thyroidectomy for Thyroid Tumors
Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2024-12-31
300
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new surgical method called Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS) for patients with thyroid tumors. This study compares DTS, a less invasive endoscopic technique, with the traditional open thyroidectomy (COT) to explore its effectiveness and safety. The study is open-label, non-randomized, and conducted at a single center, aiming to gather real-world evidence on this novel approach. Thyroid cancer and benign thyroid tumors are the conditions being studied, with an emphasis on improving incision appearance and reducing surgical trauma. The study involves two groups of 150 patients each: one group receives the DTS technique, which uses two small 1 cm puncture holes to reduce surgical trauma and postoperative pain by creating the surgical cavity directly in the neck area. The other group undergoes the traditional open thyroid surgery with collar incisions. DTS offers better visual exposure for lymph node clearance and aims to shorten hospital stays. Both groups will have their laboratory and medical data collected at specified follow-up points, with detailed recording of any adverse events. Participants will be monitored for surgical complications from the time they are assigned to a group until the first relapse of disease progression or death, with follow-up lasting up to 100 months. Secondary measures include immune and hormone levels before and after surgery, pain scores, surgery duration, hospital stay length, treatment costs, drainage volume, and wound satisfaction assessed at three months. Safety assessments include adverse events, vital signs, and pathology exams to ensure thorough evaluation of both techniques.
CONDITIONS
Official Title
Dual-port Trans-subclavian Thyroid Endoscopic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Thyroid cancer or benign thyroid tumors
- Patients who want better cosmetic results from surgery
You will not qualify if you...
- Thyroid cancer larger than 2 cm
- Benign tumors larger than 5 cm
- Severe underlying diseases
- Chronic kidney disease
- Autoimmune diseases
- Rheumatoid arthritis
AI-Screening
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Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
C
Chun Jin, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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