Clinical trial NCT03411187: Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy
Official title: Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Papillary Thyroid Carcinoma
Thyroidectomy
Endoscopy
Keywords: Endoscopy
Thyroidectomy
Thyroid Cancer
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a prospective randomized controlled study to select a continuous case of thyroid surgery in the fujian medical university union hospital from January 2017 to June 2017.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Flap separation time
timeFrame: 1 day after surgery
measure: Glandular excision time
timeFrame: 1 day after surgery
measure: Central lymph node dissection time
timeFrame: 1 day after surgery
Secondary outcomes:
measure: Times of wiping lens
timeFrame: 1 day after surgery
measure: Volume of intraoperative blood loss
timeFrame: 1 day after surgery
measure: Volume of Postoperative drainage
timeFrame: 1 day，2 day，3 day after surgery
measure: The number of identifying parathyroid glands
timeFrame: 1 day after surgery
measure: Blood PTH level
timeFrame: preoperative, first day after operation, one week after surgery, two months after surgery.
measure: Blood calcium level
timeFrame: before surgery, the first day after surgery, one week after surgery, two months after surgery.
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Wen-xin ZHAO
state: Fujian
Study officials:
References: