Back to resultsStudy on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy
Primary Purpose
Thyroid Cancer, Papillary Thyroid Carcinoma, Thyroidectomy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
used of the Pressure adjustable foot-control method
direct exhaust
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Cancer focused on measuring Endoscopy, Thyroidectomy, Thyroid Cancer
Eligibility Criteria
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.
Sites / Locations
- Wen-xin ZHAORecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
foot-control exhaust group
direct exhaust group
Arm Description
The foot-control exhaust group used of the Pressure adjustable foot-control method by the way of adjustable Pressure to intermittent exhaust
direct exhaust group exhaust through the Trocar hole.and without use of the Pressure adjustable foot-control method
Outcomes
Primary Outcome Measures
Flap separation time
Flap separation time was acquired from endoscopic video was the period from endoscopy into the body to building up operation space.
Glandular excision time
Glandular excision time was defined from incising cervical white line to removing Berry ligament.
Central lymph node dissection time
Central lymph node dissection time: was from separating central lymph node to the specimen removed.
Secondary Outcome Measures
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.
Volume of intraoperative blood loss
Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss.
Volume of Postoperative drainage
Volume of Postoperative drainage was accurately calculated the total volume while the drainage tube removed after operation.
The number of identifying parathyroid glands
The number of identifying parathyroid glands was evaluated at postoperation while parathyroid glands was identified during surgery.
Blood PTH level
measurement of PTH level in blood
Blood calcium level
to measure the blood calcium level in the blood
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03411187
Brief Title
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
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bo Wang,MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Papillary Thyroid Carcinoma, Thyroidectomy, Endoscopy
Keywords
Endoscopy, Thyroidectomy, Thyroid Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
foot-control exhaust group
Arm Type
Active Comparator
Arm Description
The foot-control exhaust group used of the Pressure adjustable foot-control method by the way of adjustable Pressure to intermittent exhaust
Arm Title
direct exhaust group
Arm Type
Placebo Comparator
Arm Description
direct exhaust group exhaust through the Trocar hole.and without use of the Pressure adjustable foot-control method
Intervention Type
Device
Intervention Name(s)
used of the Pressure adjustable foot-control method
Intervention Description
Whether The Pressure adjustable foot-control method is used.
Intervention Type
Device
Intervention Name(s)
direct exhaust
Intervention Description
direct exhaust through the trocar.
Primary Outcome Measure Information:
Title
Flap separation time
Description
Flap separation time was acquired from endoscopic video was the period from endoscopy into the body to building up operation space.
Time Frame
1 day after surgery
Title
Glandular excision time
Description
Glandular excision time was defined from incising cervical white line to removing Berry ligament.
Time Frame
1 day after surgery
Title
Central lymph node dissection time
Description
Central lymph node dissection time: was from separating central lymph node to the specimen removed.
Time Frame
1 day after surgery
Secondary Outcome Measure Information:
Title
Times of wiping lens
Description
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.
Time Frame
1 day after surgery
Title
Volume of intraoperative blood loss
Description
Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss.
Time Frame
1 day after surgery
Title
Volume of Postoperative drainage
Description
Volume of Postoperative drainage was accurately calculated the total volume while the drainage tube removed after operation.
Time Frame
1 day，2 day，3 day after surgery
Title
The number of identifying parathyroid glands
Description
The number of identifying parathyroid glands was evaluated at postoperation while parathyroid glands was identified during surgery.
Time Frame
1 day after surgery
Title
Blood PTH level
Description
measurement of PTH level in blood
Time Frame
preoperative, first day after operation, one week after surgery, two months after surgery.
Title
Blood calcium level
Description
to measure the blood calcium level in the blood
Time Frame
before surgery, the first day after surgery, one week after surgery, two months after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-xin ZHAO, MD
Phone
8613365910359
Email
zhaowx@fjmu.edu.cn
Facility Information:
Facility Name
Wen-xin ZHAO
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-xin ZHAO, MD
Phone
8613365910359
Email
zhaowx@fjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Bo WANG, MD
Phone
8613705947900
Email
wangbo@fjmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy
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