A Novel Technique for Endoscopic Transaxillary Thyroidectomy Comparison

February 27, 2023 updated by: Second Affiliated Hospital of Xi'an Jiaotong University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Xi'an, China, 710004
        • Department of General Surgery , Second Affiliated Hospita l, Xi'an Jiaotong Universi ty School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

the patient who required thyroidectomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital stay
Time Frame: 1 week
How many days will the patients stay in the hospital. The index will be reported as days.
1 week
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.
1 week
drainage volume
Time Frame: 1 week
This index will record the total volume from drainage tube after operation. It will reported as ml.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Investigators

  • Principal Investigator: Yang Liu, Xi'an Jiaotong University Second Affiliated Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 30, 2022

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thyroid Diseases

Clinical Trials on endoscopic thyroidectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe