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

September 17, 2018 updated by: Bo Wang,MD
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day after surgery
Glandular excision time
Time Frame: 1 day after surgery
Glandular excision time was defined from incising cervical white line to removing Berry ligament.
1 day after surgery
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.
1 day after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Times of wiping lens
Time Frame: 1 day after surgery
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
Time Frame: 1 day after surgery
Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss.
1 day after surgery
Volume of Postoperative drainage
Time Frame: 1 day，2 day，3 day after surgery
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
Time Frame: 1 day after surgery
The number of identifying parathyroid glands was evaluated at postoperation while parathyroid glands was identified during surgery.
1 day after surgery
Blood PTH level
Time Frame: preoperative, first day after operation, one week after surgery, two months after surgery.
measurement of PTH level in blood
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bo Wang,MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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