Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT06398795

Dual-port Trans-subclavian Thyroid Endoscopic Surgery

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

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.

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

CONTACT

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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