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

Not Applicable

• Conditions: Papillary Thyroid Carcinoma; Thyroidectomy; Endoscopy; Thyroid Cancer
• Interventions: Device: direct exhaust; Device: used of the Pressure adjustable foot-control method

• Registration Number: NCT03411187
• Lead Sponsor: Bo Wang,MD

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-01-26
• Primary Completion: 2018-06-30
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
direct exhaust group	direct exhaust	direct exhaust group exhaust through the Trocar hole.and without use of the Pressure adjustable foot-control method
foot-control exhaust group	used of the Pressure adjustable foot-control method	The foot-control exhaust group used of the Pressure adjustable foot-control method by the way of adjustable Pressure to intermittent exhaust

Primary Outcome Measures

Name	Time	Method
Flap separation time	1 day after surgery	Flap separation time was acquired from endoscopic video was the period from endoscopy into the body to building up operation space.
Central lymph node dissection time	1 day after surgery	Central lymph node dissection time: was from separating central lymph node to the specimen removed.
Glandular excision time	1 day after surgery	Glandular excision time was defined from incising cervical white line to removing Berry ligament.

Secondary Outcome Measures

Name	Time	Method
The number of identifying parathyroid glands	1 day after surgery	The number of identifying parathyroid glands was evaluated at postoperation while parathyroid glands was identified during surgery.
Blood PTH level	preoperative, first day after operation, one week after surgery, two months after surgery.	measurement of PTH level in blood
Blood calcium level	before surgery, the first day after surgery, one week after surgery, two months after surgery.	to measure the blood calcium level in the blood
Times of wiping lens	1 day after surgery	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.
Volume of Postoperative drainage	1 day，2 day，3 day after surgery	Volume of Postoperative drainage was accurately calculated the total volume while the drainage tube removed after operation.
Volume of intraoperative blood loss	1 day after surgery	Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss.

Trial Locations

Locations (1)

Wen-xin ZHAO; 🇨🇳 Fuzhou, Fujian, China