Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2022-09-01
2026-12-31
Brief Summary
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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.
Detailed Description
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Endoscopic thyroid surgery is a relatively new approach to thyroid surgery that was first developed in the 1990s. In 1996, Dr. Hiischer, an Italian surgeon, performed the first endoscopic right thyroid lobectomy. Recently, with the advent of intraoperative neuromonitoring (IONM), a technique for monitoring recurrent laryngeal nerve (RLN) function during surgery, complications of RLN injury have been effectively reduced. The introduction of high-definition endoscopy and robotic surgery in endoscopic thyroid procedures has significantly enhanced visual precision, enabling surgeons to perform complex maneuvers with increased accuracy, thereby minimizing the risk of complications and tissue injury. With the advancement of these technologies, various endoscopic thyroidectomy techniques have been developed, including chest-breast, transoral, and transaxillary approaches.
However, in comparison to COT, endoscopic thyroid surgery incurs greater trauma. This is primarily attributed to the absence of initial spaces in the neck, unlike the thoracic and abdominal cavities. Previous endoscopic procedures required creating a cavity from a distance before extending it to the neck, leading to a direct increase in the surgical trauma area. Consequently, patients undergoing endoscopic thyroid surgery may endure more substantial surgical trauma, exacerbated postoperative pain, and prolonged hospitalization. Hence, some scholars argue that the transformation of endoscopic thyroid surgery into a genuinely 'minimally invasive procedure'; necessitates further refinement.
To address the aforementioned issue, the investigators propose a pioneering approach: Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS) . DTS has the following advantages: 1) The investigators employed two 1cm puncture holes, thereby reducing the incision-related trauma to the skin and subcutaneous tissues, significantly alleviating surgical trauma and postoperative pain in patients. 2) The previous endoscopic approach involves creating an additional cavity, leading to additional trauma, whereas our method is directly constructing the cavity in situ within the neck. 3) Our endoscopic visual field is well-exposed, ensuring thorough clearance of central compartment lymph node.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DTS group
Patients undergo Dual-port Trans-subclavian Thyroid Endoscopic Surgery (DTS)
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.
COT group
Patients undergo conventional open thyroidectomy (COT)
Conventional open thyroidectomy (COT)
open thyroidectomy with traditional collar incisions
Interventions
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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.
Conventional open thyroidectomy (COT)
open thyroidectomy with traditional collar incisions
Eligibility Criteria
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Inclusion Criteria
* Patients with a demand for incisional cosmetic improvement
Exclusion Criteria
* benign tumors larger than 5 cm
* Patients with severe underlying diseases
* Patients with chronic kidney disease,
* Patients with autoimmune diseases
* Patients with rheumatoid arthritis
18 Years
90 Years
ALL
No
Sponsors
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First Affiliated Hospital of Wenzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Jiashu Wu, Profe
Role: PRINCIPAL_INVESTIGATOR
The first hospital of Wenzhou Medical University
Locations
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First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Chun Jin, Professor
Role: primary
Other Identifiers
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YLJS-2022036-01
Identifier Type: -
Identifier Source: org_study_id