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

NCT ID: NCT03411187

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-12-30

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.

Conditions

Thyroid Cancer; Papillary Thyroid Carcinoma; Thyroidectomy; Endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

used of the Pressure adjustable foot-control method

Intervention Type: DEVICE

Whether The Pressure adjustable foot-control method is used.

direct exhaust group

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

Group Type: PLACEBO_COMPARATOR

direct exhaust

Intervention Type: DEVICE

direct exhaust through the trocar.

Interventions

used of the Pressure adjustable foot-control method

Whether The Pressure adjustable foot-control method is used.

Intervention Type: DEVICE

direct exhaust

direct exhaust through the trocar.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bo Wang,MD

OTHER

Sponsor Role: lead

Responsible Party

Bo Wang,MD

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Wen-xin ZHAO

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wen-xin ZHAO, MD

Role: CONTACT

zhaowx@fjmu.edu.cn

8613365910359

Facility Contacts

Wen-xin ZHAO, MD

Role: primary

zhaowx@fjmu.edu.cn

8613365910359

Bo WANG, MD

Role: backup

wangbo@fjmu.edu.cn

8613705947900

Other Identifiers

exhaust

Identifier Type: -

Identifier Source: org_study_id