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

Inclusion Criteria2

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

Exclusion Criteria6

  • 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

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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