RecruitingNot ApplicableNCT06398795

Dual-port Trans-subclavian Thyroid Endoscopic Surgery

Dual-port Trans-subclavian Thyroid Endoscopic Surgery - an Exploration of Cavity Construction in Situ Heralds a New Approach Choice


Sponsor

First Affiliated Hospital of Wenzhou Medical University

Enrollment

300 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a minimally invasive surgical technique for removing the thyroid gland through two small incisions under the collarbone (subclavian area), which avoids leaving a scar on the neck. The goal is to see if this approach is safe and provides good cosmetic results. **You may be eligible if...** - You have been diagnosed with thyroid cancer or a non-cancerous thyroid tumor - You are concerned about visible neck scarring from surgery **You may NOT be eligible if...** - Your thyroid cancer is larger than 2 cm - Your benign (non-cancerous) thyroid tumor is larger than 5 cm - You have severe underlying health conditions - You have chronic kidney disease - You have an autoimmune disease - You have rheumatoid arthritis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS).

An 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.

PROCEDUREConventional open thyroidectomy (COT)

open thyroidectomy with traditional collar incisions


Locations(1)

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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NCT06398795


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