Comparing the Establishment of Operation Space Between High Position and Low Position in Endoscopic Thyroid Surgery

September 17, 2018 updated by: Bo Wang,MD, Fujian Medical University

Comparing the Two Ways of Creating a High Position and Low Position Operating Space in Endoscopic Thyroid Surgery

Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group. The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group.The sternum angle level is used as the dividing line between the two groups。The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

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
    • Fujian
      • FuZhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with endoscopic thyroid surgery
  • No previous neck surgery

Exclusion Criteria:

  • Patients undergoing lateral neck lymph node dissection during the same period

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high position space group
The left and right Trocar meet at the level of the sternum angle and begin to establish the operating space.
Procedure: high position space group
The left and right Trocar meet at the level of the sternum angle and begin to establish the operating space.
Experimental: low position space group
The left and right Trocar meet under the sternum angle and begin to establish the operating space.
Procedure: low position space group
The left and right Trocar meet under the sternum angle and begin to establish the operating space.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intercostal arterial bleeding
Time Frame: During surgery
The number of intercostal artery bleeding
During surgery
Thyroidectomy time
Time Frame: During surgery
Time to complete removal of thyroid gland specimens starting from the establishment of the operating space (minutes)
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thyroid volume
Time Frame: Before surgery
Thyroid volume calculated by preoperative ultrasound
Before surgery
Patient's BMI
Time Frame: Before surgery
BMI equals body weight divided by height squared
Before surgery
Assessment of skin sensory abnormalities
Time Frame: two months after surgery
According to the visual scoring method, it was divided into 1-10 points and evaluated by the patient two months after surgery. The score of 10 points was the same as before surgery, and 0 points showed serious discomfort.
two months after surgery

Collaborators and Investigators

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

Sponsor

Fujian Medical University

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)

June 1, 2018

Primary Completion (Actual)

August 31, 2018

Study Completion (Anticipated)

October 31, 2018

Study Registration Dates

First Submitted

June 24, 2018

First Submitted That Met QC Criteria

June 24, 2018

First Posted (Actual)

July 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Space H and L

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.

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