Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy
From the Endoscope to the Robot, the Initial Experience of Robotic Thyroidectomy is Summarized
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 7, 2018
CompletedFirst Posted
Study publicly available on registry
March 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedSeptember 18, 2018
September 1, 2018
8 months
February 7, 2018
September 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
operation time
Assess the operation time
The first day after surgery
recurrent laryngeal nerve palsy
the number of recurrent laryngeal nerve palsy
2 months post operation
Secondary Outcomes (2)
thyroid volume
The day before the operation
cosmetic effect
2 months post operation
Study Arms (3)
conventional open surgery
EXPERIMENTALPatients who met the inclusion criteria were selected for a conventional open surgery procedure for a conventional neck incision for thyroid surgery.
endoscopic thyroidectomy
EXPERIMENTALPatients who met the inclusion criteria were selected to undergo thyroid surgery via endoscopic thyroidectomy
robotic thyroidectomy
EXPERIMENTALPatients who met the inclusion criteria chose the Da Vinci robot for thyroid surgery.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients without beauty needs.
- There is lateral neck or mediastinal lymph node metastasis.
- The tumor invades the nerve and surrounding organs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wen-xin ZHAO
Fuzhou, Fujian, 350001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
February 7, 2018
First Posted
March 6, 2018
Study Start
February 1, 2018
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
September 18, 2018
Record last verified: 2018-09