Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID06398795

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

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Thyroid cancer or benign thyroid tumors
  • Patients who want better cosmetic results from surgery
Not Eligible

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

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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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