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

Bo Wang,MD

Status: Unknown

Conditions: Papillary Thyroid Carcinoma; Thyroid Cancer; Thyroidectomy; Endoscopy

Treatments: Device: used of the Pressure adjustable foot-control method; Device: direct exhaust

Study type: Interventional

Funder types: Other

Identifiers

NCT03411187

exhaust

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

foot-control exhaust group

Active Comparator group

Description:

The foot-control exhaust group used of the Pressure adjustable foot-control method by the way of adjustable Pressure to intermittent exhaust

Treatment:

Device: used of the Pressure adjustable foot-control method

direct exhaust group

Placebo Comparator group

Description:

direct exhaust group exhaust through the Trocar hole.and without use of the Pressure adjustable foot-control method

Treatment:

Device: direct exhaust