Actively Recruiting

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

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

Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2024-12-31

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are exploring a new surgical method called Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS) for patients with thyroid tumors. This open-label, non-randomized study compares DTS with the traditional open thyroidectomy (COT) to assess safety and effectiveness. The trial aims to build evidence on how this new approach may improve surgery outcomes and reduce complications for thyroid cancer and benign tumors. The study involves two groups: one undergoing the innovative DTS technique using two small puncture holes to minimize trauma and improve cosmetic results, and the other receiving the standard open thyroid surgery with collar incisions. DTS creates a surgical cavity directly in the neck, potentially reducing tissue damage, pain, and hospital stay compared to the conventional method. Both groups receive surgery as per their treatment choice, and detailed medical data are collected throughout. Participants will be monitored before and after surgery through laboratory tests measuring immune and hormonal markers, pain assessments, and tracking of surgical outcomes like hospital stay length and wound satisfaction over three months. Safety is carefully observed through recording adverse events, vital signs, and pathology exams. The primary measure is the rate of postoperative complications, with follow-up extending up to 100 months to evaluate long-term results.

CONDITIONS

Brief Title

Dual-port Trans-subclavian Thyroid Endoscopic Surgery

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 90 years
  • Diagnosed with thyroid cancer or benign thyroid tumors
  • Patients seeking improved cosmetic results from surgery
Not Eligible

You will not qualify if you...

  • Thyroid cancer larger than 2 cm
  • Benign tumors larger than 5 cm
  • Presence of severe underlying diseases
  • Chronic kidney disease
  • Autoimmune diseases
  • Rheumatoid arthritis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to discharge from hospital

Participants undergo either Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS) or conventional open thyroidectomy (COT), followed by immediate post-operative care to monitor recovery and manage any complications.

1 surgical procedure and approximately 1 hospital stay

Post-operative Follow-up

Duration - Up to 100 months

Participants receive follow-up visits to assess recovery, monitor for postoperative complications, and evaluate surgical outcomes.

Scheduled visits as determined by the clinical team over the follow-up period

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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