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

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ClinicalTrials.gov Identifier: NCT03411187
Recruitment Status : Unknown
Verified September 2018 by Bo Wang,MD, Fujian Medical University.
Recruitment status was:  Recruiting
First Posted : January 26, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bo Wang,MD, Fujian Medical University

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.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Papillary Thyroid Carcinoma Thyroidectomy Endoscopy Device: used of the Pressure adjustable foot-control method Device: direct exhaust Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. Glandular excision time [ Time Frame: 1 day after surgery ]
    Glandular excision time was defined from incising cervical white line to removing Berry ligament.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. Volume of intraoperative blood loss [ Time Frame: 1 day after surgery ]
    Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss.

  3. 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.

  4. 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.

  5. Blood PTH level [ Time Frame: preoperative, first day after operation, one week after surgery, two months after surgery. ]
    measurement of PTH level in blood

  6. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411187


Contacts
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Contact: Wen-xin ZHAO, MD 8613365910359 zhaowx@fjmu.edu.cn

Locations
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China, Fujian
Wen-xin ZHAO Recruiting
Fuzhou, Fujian, China, 350001
Contact: Wen-xin ZHAO, MD    8613365910359    zhaowx@fjmu.edu.cn   
Contact: Bo WANG, MD    8613705947900    wangbo@fjmu.edu.cn   
Sponsors and Collaborators
Bo Wang,MD
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Responsible Party: Bo Wang,MD, Clinical Professor, Fujian Medical University
ClinicalTrials.gov Identifier: NCT03411187    
Other Study ID Numbers: exhaust
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bo Wang,MD, Fujian Medical University:
Endoscopy
Thyroidectomy
Thyroid Cancer
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Adenocarcinoma, Papillary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type