NCT05735054

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

February 9, 2023

Last Update Submit

February 27, 2023

Conditions

Keywords

endoscopythyroidectomytransaxillaryopen

Outcome Measures

Primary Outcomes (3)

  • operation time (OT)

    The time will be reported as minutes.

    during the operation

  • bleeding

    intraoperatively bleeding volume. The intraoperative blood lose volume will be reported as ml.

    during the operation

  • complications

    any complications after operation

    6 moths after oepration

Secondary Outcomes (3)

  • hospital stay

    1 week

  • drainage days.

    1 week

  • drainage volume

    1 week

Study Arms (2)

endoscopic group

the patients who underwent endoscopic transaxillary thyroidectomy

Procedure: endoscopic thyroidectomy

open group

the patients who underwent open thyroidectomy

Procedure: endoscopic thyroidectomy

Interventions

the patients who underwent endoscopic transaxillary thyroidectomy

endoscopic groupopen group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the patient who required thyroidectomy

You may qualify if:

  • The patients with benign or malignant thyroid disease require lobe thyroidectomy;
  • The patient had cosmetic requirements and agreed with transaxillary thyroidectomy;
  • Benign lesions with the largest diameter ≤5 cm;
  • 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;

You may not qualify if:

  • the patients had poor compliance and could not be reexamined regularly;
  • There was a history of neck or thyroid surgery;
  • The patients require total thyroidectomy or lateral neck dissection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Xi'an, 710004, China

Location

Related Publications (1)

  • Liu Y, Wang J, Chen S, Lv H, Yu S, Ran X, Gao N, Sun Y, Cao G. Preliminary report on a novel technique for endoscopic transaxillary thyroidectomy: a case-control study. Int J Surg. 2024 Feb 1;110(2):654-659. doi: 10.1097/JS9.0000000000000885.

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Yang Liu

    Xi'an Jiaotong University Second Affiliated Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 21, 2023

Study Start

January 1, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2024

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations