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

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.

Study Overview

• Status: Unknown
• Conditions: Endoscopy; Papillary Thyroid Carcinoma; Thyroid Cancer; Thyroidectomy
• Intervention / Treatment: Device: used of the Pressure adjustable foot-control method; Device: direct exhaust

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Wen-xin ZHAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flap separation time	Flap separation time was acquired from endoscopic video was the period from endoscopy into the body to building up operation space.	1 day after surgery
Glandular excision time	Glandular excision time was defined from incising cervical white line to removing Berry ligament.	1 day after surgery
Central lymph node dissection time	Central lymph node dissection time: was from separating central lymph node to the specimen removed.	1 day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Times of wiping lens	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.	1 day after surgery
Volume of intraoperative blood loss	Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss.	1 day after surgery
Volume of Postoperative drainage	Volume of Postoperative drainage was accurately calculated the total volume while the drainage tube removed after operation.	1 day，2 day，3 day after surgery
The number of identifying parathyroid glands	The number of identifying parathyroid glands was evaluated at postoperation while parathyroid glands was identified during surgery.	1 day after surgery
Blood PTH level	measurement of PTH level in blood	preoperative, first day after operation, one week after surgery, two months after surgery.
Blood calcium level	to measure the blood calcium level in the blood	before surgery, the first day after surgery, one week after surgery, two months after surgery.

Collaborators and Investigators

• Sponsor: Bo Wang,MD

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Endoscopy; Thyroidectomy; Thyroid Cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Adenocarcinoma, Papillary; Thyroid Diseases; Thyroid Neoplasms; Thyroid Cancer, Papillary
• Other Study ID Numbers: exhaust

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No