Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398795
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-22
Brief Title:
Dual-port Trans-subclavian Thyroid Endoscopic Surgery
Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Organization:
First Affiliated Hospital of Wenzhou Medical University
Study Overview
Official Title:
Dual-port Trans-subclavian Thyroid Endoscopic Surgery - an Exploration of Cavity Construction in Situ Heralds a New Approach Choice
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DTS
Brief 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
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:
In the past years the prevalence of thyroid cancer TC has increased markedly across numerous regions and nations 94 of TC are differentiated thyroid carcinomas DTC and thyroidectomyis widely accepted as the most optimal therapeutic option for patients diagnosed with DTC The conventional method for performing thyroidectomy is through an open approach known as collar incision thyroidectomy or conventional open thyroidectomy COT which is commonly recognized as the standard technique
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None