This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Novel Technique for Endoscopic Transaxillary Thyroidectomy Comparison

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05735054
Recruitment Status : Active, not recruiting
First Posted : February 21, 2023
Last Update Posted : February 28, 2023
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Xi'an Jiaotong University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Thyroid Diseases Procedure: endoscopic thyroidectomy

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Novel Technique for Endoscopic Transaxillary Thyroidectomy: a Preliminary Report and Comparison With the Open Procedure
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
endoscopic group
the patients who underwent endoscopic transaxillary thyroidectomy
 Procedure: endoscopic thyroidectomy
the patients who underwent endoscopic transaxillary thyroidectomy
open group
the patients who underwent open thyroidectomy
 Procedure: endoscopic thyroidectomy
the patients who underwent endoscopic transaxillary thyroidectomy


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. operation time (OT) [ Time Frame: during the operation ]
    The time will be reported as minutes.

  2. bleeding [ Time Frame: during the operation ]
    intraoperatively bleeding volume. The intraoperative blood lose volume will be reported as ml.

  3. complications [ Time Frame: 6 moths after oepration ]
    any complications after operation


Secondary Outcome Measures :
  1. hospital stay [ Time Frame: 1 week ]
    How many days will the patients stay in the hospital. The index will be reported as days.

  2. drainage days. [ Time Frame: 1 week ]
    This index will record how many days does the drainage tube keep in the paitients. It will reported as days.

  3. drainage volume [ Time Frame: 1 week ]
    This index will record the total volume from drainage tube after operation. It will reported as ml.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
the patient who required thyroidectomy
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05735054


Locations
Layout table for location information
China
Department of General Surgery , Second Affiliated Hospita l, Xi'an Jiaotong Universi ty School of Medicine
Xi'an, China, 710004
Sponsors and Collaborators
Second Affiliated Hospital of Xi'an Jiaotong University
Investigators
Layout table for investigator information
Principal Investigator: Yang Liu Xi'an Jiaotong University Second Affiliated Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Second Affiliated Hospital of Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT05735054    
Other Study ID Numbers: 202303
First Posted: February 21, 2023    Key Record Dates
Last Update Posted: February 28, 2023
Last Verified: February 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital of Xi'an Jiaotong University:
endoscopy
thyroidectomy
transaxillary
open
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Diseases
Endocrine System Diseases