A Novel Technique for Endoscopic Transaxillary Thyroidectomy Comparison

Thyroid Diseases Clinical Trial

Official title:

A Novel Technique for Endoscopic Transaxillary Thyroidectomy: a Preliminary Report and Comparison With the Open Procedure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05735054
• Other study ID #: 202303
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The clinical data from all except the first 20 cases who underwent our novel transaxillary thyroidectomy were collected retrospectively, while the data from patients who underwent conventional open thyroid lobectomy by same surgeon during the same period were used as a control.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. The patients with benign or malignant thyroid disease require lobe thyroidectomy;

2. The patient had cosmetic requirements and agreed with transaxillary thyroidectomy;

3. Benign lesions with the largest diameter =5 cm;

4. Differentiated thyroid cancer(DTC) meets the following conditions at the same time:

?The maximum diameter of the primary lesion is <2.5 cm; ?There is no extraglandular invasion or only minimal external invasion of the anterior thyroid capsule or minor invasion of the sternum thyroid muscle;

Exclusion Criteria:

1. the patients had poor compliance and could not be reexamined regularly;

2. There was a history of neck or thyroid surgery;

3. The patients require total thyroidectomy or lateral neck dissection.

Related Conditions & MeSH terms

• Thyroid Diseases

Intervention

Procedure:
• endoscopic thyroidectomy
the patients who underwent endoscopic transaxillary thyroidectomy

Locations

Country	Name	City	State
China	Department of General Surgery , Second Af?liated Hospita l, Xi'an Jiaotong Universi ty School of Medicine	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operation time (OT)	The time will be reported as minutes.	during the operation
Primary	bleeding	intraoperatively bleeding volume. The intraoperative blood lose volume will be reported as ml.	during the operation
Primary	complications	any complications after operation	6 moths after oepration
Secondary	hospital stay	How many days will the patients stay in the hospital. The index will be reported as days.	1 week
Secondary	drainage days.	This index will record how many days does the drainage tube keep in the paitients. It will reported as days.	1 week
Secondary	drainage volume	This index will record the total volume from drainage tube after operation. It will reported as ml.	1 week