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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
|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|
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.
- 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.
- 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.
- Volume of intraoperative blood loss [ Time Frame: 1 day after surgery ]Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss.
- 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.
- 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.
- Blood PTH level [ Time Frame: preoperative, first day after operation, one week after surgery, two months after surgery. ]measurement of PTH level in blood
- 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
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
|Contact: Wen-xin ZHAO, MDemail@example.com|