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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03577951
• Other study ID #: Space H and L
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: September 2018
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with endoscopic thyroid surgery

• No previous neck surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Endoscopy
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	FuZhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intercostal arterial bleeding	The number of intercostal artery bleeding	During surgery
Primary	Thyroidectomy time	Time to complete removal of thyroid gland specimens starting from the establishment of the operating space (minutes)	During surgery
Secondary	Thyroid volume	Thyroid volume calculated by preoperative ultrasound	Before surgery
Secondary	Patient's BMI	BMI equals body weight divided by height squared	Before surgery
Secondary	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.	two months after surgery