A Novel Technique for Endoscopic Transaxillary Thyroidectomy Comparison

Active, not recruiting

• Conditions: Thyroid Diseases
• Interventions: Procedure: endoscopic thyroidectomy

• Registration Number: NCT05735054
• Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-30
• Status Verified: 2023-02
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-21
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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: ①The maximum diameter of the primary lesion is <2.5 cm; ②There 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
open group	endoscopic thyroidectomy	the patients who underwent open thyroidectomy
endoscopic group	endoscopic thyroidectomy	the patients who underwent endoscopic transaxillary thyroidectomy

Primary Outcome Measures

Name	Time	Method
operation time (OT)	during the operation	The time will be reported as minutes.
bleeding	during the operation	intraoperatively bleeding volume. The intraoperative blood lose volume will be reported as ml.
complications	6 moths after oepration	any complications after operation

Secondary Outcome Measures

Name	Time	Method
hospital stay	1 week	How many days will the patients stay in the hospital. The index will be reported as days.
drainage days.	1 week	This index will record how many days does the drainage tube keep in the paitients. It will reported as days.
drainage volume	1 week	This index will record the total volume from drainage tube after operation. It will reported as ml.

Trial Locations

Locations (1)

Department of General Surgery , Second Affiliated Hospita l, Xi'an Jiaotong Universi ty School of Medicine; 🇨🇳 Xi'an, China