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

Primary Purpose

Thyroid Cancer, Endoscopy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
high position space group
low position space group
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with endoscopic thyroid surgery
  • No previous neck surgery

Exclusion Criteria:

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

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

high position space group

low position space group

Arm Description

The left and right Trocar meet at the level of the sternum angle and begin to establish the operating space.

The left and right Trocar meet under the sternum angle and begin to establish the operating space.

Outcomes

Primary Outcome Measures

Intercostal arterial bleeding
The number of intercostal artery bleeding
Thyroidectomy time
Time to complete removal of thyroid gland specimens starting from the establishment of the operating space (minutes)

Secondary Outcome Measures

Thyroid volume
Thyroid volume calculated by preoperative ultrasound
Patient's BMI
BMI equals body weight divided by height squared
Assessment of skin sensory abnormalities
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.

Full Information

First Posted
June 24, 2018
Last Updated
September 17, 2018
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03577951
Brief Title
Comparing the Establishment of Operation Space Between High Position and Low Position in Endoscopic Thyroid Surgery
Official Title
Comparing the Two Ways of Creating a High Position and Low Position Operating Space in Endoscopic Thyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Endoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high position space group
Arm Type
Experimental
Arm Description
The left and right Trocar meet at the level of the sternum angle and begin to establish the operating space.
Arm Title
low position space group
Arm Type
Experimental
Arm Description
The left and right Trocar meet under the sternum angle and begin to establish the operating space.
Intervention Type
Procedure
Intervention Name(s)
high position space group
Intervention Description
The left and right Trocar meet at the level of the sternum angle and begin to establish the operating space.
Intervention Type
Procedure
Intervention Name(s)
low position space group
Intervention Description
The left and right Trocar meet under the sternum angle and begin to establish the operating space.
Primary Outcome Measure Information:
Title
Intercostal arterial bleeding
Description
The number of intercostal artery bleeding
Time Frame
During surgery
Title
Thyroidectomy time
Description
Time to complete removal of thyroid gland specimens starting from the establishment of the operating space (minutes)
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Thyroid volume
Description
Thyroid volume calculated by preoperative ultrasound
Time Frame
Before surgery
Title
Patient's BMI
Description
BMI equals body weight divided by height squared
Time Frame
Before surgery
Title
Assessment of skin sensory abnormalities
Description
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.
Time Frame
two months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with endoscopic thyroid surgery No previous neck surgery Exclusion Criteria: Patients undergoing lateral neck lymph node dissection during the same period
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
FuZhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
bo wang, md
Phone
13705947900
Email
wangbo@fjmu.edu.cn

12. IPD Sharing Statement

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

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