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

Sponsor

Bo Wang,MD (Other)

Overall Status

Unknown status

CT.gov ID

NCT03411187

Collaborator

(none)

100

Enrollment

Location

Arms

11.9

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Cancer Papillary Thyroid Carcinoma Thyroidectomy Endoscopy	Device: used of the Pressure adjustable foot-control method Device: direct exhaust	N/A

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

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jun 30, 2018

Anticipated Study Completion Date :

Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Device: used of the Pressure adjustable foot-control method Whether The Pressure adjustable foot-control method is used.
Placebo Comparator: direct exhaust group direct exhaust group exhaust through the Trocar hole.and without use of the Pressure adjustable foot-control method	Device: direct exhaust direct exhaust through the trocar.

Arm

Intervention/Treatment

Active Comparator: 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

Device: used of the Pressure adjustable foot-control method

Whether The Pressure adjustable foot-control method is used.

Placebo Comparator: direct exhaust group

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

Device: direct exhaust

direct exhaust through the trocar.

Outcome Measures

Primary Outcome Measures

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.
Glandular excision time [1 day after surgery]
Glandular excision time was defined from incising cervical white line to removing Berry ligament.
Central lymph node dissection time [1 day after surgery]
Central lymph node dissection time: was from separating central lymph node to the specimen removed.

Secondary Outcome Measures

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 intraoperative blood loss [1 day after surgery]
Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss.
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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.