Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy

Thyroid Cancer Clinical Trial

Official title:

Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03411187
• Other study ID #: exhaust
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: September 2018
• Source: Fujian Medical University
• Contact: Wen-xin ZHAO, MD
• Phone: 8613365910359
• Email: zhaowx[@]fjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endoscopic thyroidectomy developed rapidly in recent years, and the most popular surgical approach was endoscopic thyroidectomy by bilateral areola approach, but some operative steps was required optimization. One of the most annoying problem was the smog blurring endoscopic lens during surgery. The researcher summarized a set of convenient foot-control exhaust method and carried out this prospective study.

Description:

The patients with papillary thyroid microcarcinoma were included according to the inclusive criteria and randomly divided them into two groups (foot-control exhaust group and direct exhaust group). The foot-control exhaust group used the foot-control exhaust method by the way of adjustable Pressure to intermittent exhaust, while direct exhaust group exhaust through the Trocar hole. Comparison of operation time, times of wiping the endoscopic lens, volume of postoperative drainage, and number of identified parathyroid gland between two groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients with maximum tumor diameter =1 cm;

2. patients without lateral neck lymph node metastases;

3. patients without distant metastases;

4. patients who only needed unilateral surgery following the guidelines;

5. patients with strong cosmetic requirement.

Exclusion criteria:

1. Patients with maximum tumor diameter >1 cm;

2. patients who needed complement total thyroidectomy according to the guidelines, including tumor extrathyroidal extension as well as large amount of neck lymph node metastases and distant metastases;

3. patients without cosmetic requirements.

Related Conditions & MeSH terms

• Carcinoma
• Endoscopy
• Papillary Thyroid Carcinoma
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroidectomy

Intervention

Device:
• used of the Pressure adjustable foot-control method
Whether The Pressure adjustable foot-control method is used.
• direct exhaust
direct exhaust through the trocar.

Locations

Country	Name	City	State
China	Wen-xin ZHAO	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Bo Wang,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flap separation time	Flap separation time was acquired from endoscopic video was the period from endoscopy into the body to building up operation space.	1 day after surgery
Primary	Glandular excision time	Glandular excision time was defined from incising cervical white line to removing Berry ligament.	1 day after surgery
Primary	Central lymph node dissection time	Central lymph node dissection time: was from separating central lymph node to the specimen removed.	1 day after surgery
Secondary	Times of wiping lens	Times of wiping lens calculated from endoscopic video after operation was defined the times of wiping lens from endoscopy into the body to central lymph node removed.	1 day after surgery
Secondary	Volume of intraoperative blood loss	Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss.	1 day after surgery
Secondary	Volume of Postoperative drainage	Volume of Postoperative drainage was accurately calculated the total volume while the drainage tube removed after operation.	1 day,2 day,3 day after surgery
Secondary	The number of identifying parathyroid glands	The number of identifying parathyroid glands was evaluated at postoperation while parathyroid glands was identified during surgery.	1 day after surgery
Secondary	Blood PTH level	measurement of PTH level in blood	preoperative, first day after operation, one week after surgery, two months after surgery.
Secondary	Blood calcium level	to measure the blood calcium level in the blood	before surgery, the first day after surgery, one week after surgery, two months after surgery.