Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Flap separation time
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with maximum tumor diameter ≤1 cm;
- •patients without lateral neck lymph node metastases;
- •patients without distant metastases;
- •patients who only needed unilateral surgery following the guidelines;
- •patients with strong cosmetic requirement.
Exclusion Criteria
- •Patients with maximum tumor diameter >1 cm;
- •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;
- •patients without cosmetic requirements.
Arms & Interventions
foot-control exhaust group
The foot-control exhaust group used of the Pressure adjustable foot-control method by the way of adjustable Pressure to intermittent exhaust
Intervention: used of the Pressure adjustable foot-control method (Device)
direct exhaust group
direct exhaust group exhaust through the Trocar hole.and without use of the Pressure adjustable foot-control method
Intervention: direct exhaust (Device)
Outcomes
Primary Outcomes
Flap separation time
Time Frame: 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
Time Frame: 1 day after surgery
Central lymph node dissection time: was from separating central lymph node to the specimen removed.
Glandular excision time
Time Frame: 1 day after surgery
Glandular excision time was defined from incising cervical white line to removing Berry ligament.
Secondary Outcomes
- The number of identifying parathyroid glands(1 day after surgery)
- Blood PTH level(preoperative, first day after operation, one week after surgery, two months after surgery.)
- Blood calcium level(before surgery, the first day after surgery, one week after surgery, two months after surgery.)
- Times of wiping lens(1 day after surgery)
- Volume of Postoperative drainage(1 day，2 day，3 day after surgery)
- Volume of intraoperative blood loss(1 day after surgery)
Investigators
Bo Wang,MD
Clinical Professor
Fujian Medical University