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Dual-port Trans-subclavian Thyroid Endoscopic Surgery

NCT06398795 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-12-31

No results posted yet for this study

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.

Conditions

  • Thyroid Neoplasms
  • Endoscopic Surgery

Interventions

PROCEDURE

Dual-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.

PROCEDURE

Conventional open thyroidectomy (COT)

open thyroidectomy with traditional collar incisions

Sponsors & Collaborators

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Jiashu Wu, Profe · The first hospital of Wenzhou Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06398795 on ClinicalTrials.gov