Thyroid CancerNCT03411187
Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy
A study testing direct exhaust in people with Thyroid Cancer and Papillary Thyroid Carcinoma, run by Bo Wang,MD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Cancer, Papillary Thyroid Carcinoma, Thyroidectomy
- What is being tested?
- direct exhaust
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wen-xin ZHAO
Fuzhou, Fujian, 350001
Wen-xin ZHAO, MD, 8613365910359, zhaowx@fjmu.edu.cn
Bo WANG, MD, 8613705947900, wangbo@fjmu.edu.cn
About this study
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.
Read the 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
- Being tested
- used of the Pressure adjustable foot-control method, direct exhaust
- Keywords
- Endoscopy, Thyroidectomy, Thyroid Cancer
- Medical subject headings
- Thyroid Neoplasms, Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
used of the Pressure adjustable foot-control methodDevice
Whether The Pressure adjustable foot-control method is used.
direct exhaustDevice
direct exhaust through the trocar.
| Study group | Role | What they receive |
|---|---|---|
| foot-control exhaust group | Active comparator | The foot-control exhaust group used of the Pressure adjustable foot-control method by the way of adjustable Pressure to intermittent exhaust Receives: Device: used of the Pressure adjustable foot-control method |
| direct exhaust group | Placebo comparator | direct exhaust group exhaust through the Trocar hole.and without use of the Pressure adjustable foot-control method Receives: Device: direct exhaust |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap separation time
Flap separation time was acquired from endoscopic video was the period from endoscopy into the body to building up operation space.
Measured: 1 day after surgery
Glandular excision time
Glandular excision time was defined from incising cervical white line to removing Berry ligament.
Measured: 1 day after surgery
Central lymph node dissection time
Central lymph node dissection time: was from separating central lymph node to the specimen removed.
Measured: 1 day after surgery
Secondary outcomes (6)
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.
Measured: 1 day after surgery
Volume of intraoperative blood loss
Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss.
Measured: 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.
Measured: 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.
Measured: 1 day after surgery
Blood PTH level
measurement of PTH level in blood
Measured: 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
Measured: before surgery, the first day after surgery, one week after surgery, two months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Jan 2018
- Primary completion30 Jun 2018
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bo Wang,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bo Wang,MD, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411187
- Sponsor's protocol ID
- exhaust
- Status last verified
- Sep 2018
- First submitted
- 19 Jan 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy
- ClinicalTrials.gov ID
- NCT03411187
- Acronym / sponsor ID
- exhaust
- Conditions
- Thyroid Cancer, Papillary Thyroid Carcinoma, Thyroidectomy, Endoscopy
- Keywords
- Endoscopy, Thyroidectomy, Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bo Wang,MDUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| foot-control exhaust group | Active comparator | Device: used of the Pressure adjustable foot-control methodThe foot-control exhaust group used of the Pressure adjustable foot-control method by the way of adjustable Pressure to intermittent exhaust |
| direct exhaust group | Placebo comparator | Device: direct exhaustdirect exhaust group exhaust through the Trocar hole.and without use of the Pressure adjustable foot-control method |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| used of the Pressure adjustable foot-control methodWhether The Pressure adjustable foot-control method is used. | Device | foot-control exhaust group |
| direct exhaustdirect exhaust through the trocar. | Device | direct exhaust group |
Primary outcome
Flap separation time
Time frame: 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
Time frame: 1 day after surgery
Glandular excision time was defined from incising cervical white line to removing Berry ligament.
Central lymph node dissection time
Time frame: 1 day after surgery
Central lymph node dissection time: was from separating central lymph node to the specimen removed.
6 secondary outcomes
Times of wiping lens
Time frame: 1 day after surgery
Volume of intraoperative blood loss
Time frame: 1 day after surgery
Volume of Postoperative drainage
Time frame: 1 day，2 day，3 day after surgery
The number of identifying parathyroid glands
Time frame: 1 day after surgery
Blood PTH level
Time frame: preoperative, first day after operation, one week after surgery, two months after surgery.
Blood calcium level
Time frame: before surgery, the first day after surgery, one week after surgery, two months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct exhaust in people with Thyroid Cancer and Papillary Thyroid Carcinoma, run by Bo Wang,MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-xin ZHAO, MD (8613365910359, zhaowx@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flap separation time (time frame: 1 day after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.