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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03411187
Enrollment
100
Registered
2018-01-26
Start date
2018-01-01
Completion date
2018-12-30
Last updated
2018-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopy, Papillary Thyroid Carcinoma, Thyroid Cancer, Thyroidectomy

Keywords

Endoscopy, Thyroidectomy, Thyroid Cancer

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.

Interventions

DEVICEused of the Pressure adjustable foot-control method

Whether The Pressure adjustable foot-control method is used.

DEVICEdirect exhaust

direct exhaust through the trocar.

Sponsors

Bo Wang,MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Central lymph node dissection time1 day after surgeryCentral lymph node dissection time: was from separating central lymph node to the specimen removed.
Flap separation time1 day after surgeryFlap separation time was acquired from endoscopic video was the period from endoscopy into the body to building up operation space.
Glandular excision time1 day after surgeryGlandular excision time was defined from incising cervical white line to removing Berry ligament.

Secondary

MeasureTime frameDescription
The number of identifying parathyroid glands1 day after surgeryThe number of identifying parathyroid glands was evaluated at postoperation while parathyroid glands was identified during surgery.
Times of wiping lens1 day after surgeryTimes 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.
Blood calcium levelbefore surgery, the first day after surgery, one week after surgery, two months after surgery.to measure the blood calcium level in the blood
Blood PTH levelpreoperative, first day after operation, one week after surgery, two months after surgery.measurement of PTH level in blood
Volume of intraoperative blood loss1 day after surgeryVolume of intraoperative blood loss was estimated the volume of intraoperative blood loss.
Volume of Postoperative drainage1 day,2 day,3 day after surgeryVolume of Postoperative drainage was accurately calculated the total volume while the drainage tube removed after operation.

Countries

China

Contacts

Primary ContactWen-xin ZHAO, MD
zhaowx@fjmu.edu.cn8613365910359

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026