From the Endoscope to the Robot, the Initial Experience of Robotic Thyroidectomy is Summarized
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- recurrent laryngeal nerve palsy
Study Overview
Brief Summary
Comparison of endoscopic thyroidectomy, robotic thyroidectomy and conventional open surgery, the safety of the operation, the timing of the operation and the complications.
Detailed Description
With the further development of endoscopic technique, thyroid surgery of the robot has emerged, which may become a trend of endoscopic technology due to its convenience and accuracy.In this study, the advantages and disadvantages of endoscopic thyroidectomy and robotic thyroid surgery were compared, and the experience in the transition stage of thyroid surgery in robotic and endoscopic thyroidectomy was summarized.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Thyroid papillary carcinoma.
- •The tumor diameter is less than or equal to 1cm.
- •The lymph nodes are limited to the VI level.
- •Voluntary choice of endoscopy or robotic surgery.
Exclusion Criteria
- •Patients without beauty needs.
- •There is lateral neck or mediastinal lymph node metastasis.
- •The tumor invades the nerve and surrounding organs.
Arms & Interventions
conventional open surgery
Patients who met the inclusion criteria were selected for a conventional open surgery procedure for a conventional neck incision for thyroid surgery.
Intervention: conventional open surgery (Procedure)
endoscopic thyroidectomy
Patients who met the inclusion criteria were selected to undergo thyroid surgery via endoscopic thyroidectomy
Intervention: endoscopic thyroidectomy (Procedure)
robotic thyroidectomy
Patients who met the inclusion criteria chose the Da Vinci robot for thyroid surgery.
Intervention: robotic thyroidectomy (Device)
Outcomes
Primary Outcomes
recurrent laryngeal nerve palsy
Time Frame: 2 months post operation
the number of recurrent laryngeal nerve palsy
operation time
Time Frame: The first day after surgery
Assess the operation time
Secondary Outcomes
- cosmetic effect(2 months post operation)
- thyroid volume(The day before the operation)
Investigators
Bo Wang,MD
clinical professor
Fujian Medical University