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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Thyroid cancer or benign thyroid tumors

• Patients with a demand for incisional cosmetic improvement

Locations
Other Locations
China
First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
Chun Jin, Professor
845095442@qq.com
86-13858707259
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 300
Treatments
Experimental: DTS group
Patients undergo Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS)
Active_comparator: COT group
Patients undergo conventional open thyroidectomy (COT)
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Wenzhou Medical University

This content was sourced from clinicaltrials.gov