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Status unknownNCT03454477Updated Sep 18, 2018

Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy

An interventional study of conventional open surgery and endoscopic thyroidectomy in Endoscopy, Robotics and Thyroidectomy, sponsored by Fujian Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-09-18.

Sponsored by Fujian Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Comparison of endoscopic thyroidectomy, robotic thyroidectomy and conventional open surgery, the safety of the operation, the timing of the operation and the complications.

Read the 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.

02

Conditions studied

  • Endoscopy
  • Robotics
  • Thyroidectomy
  • Papillary Thyroid Carcinoma

Keywords

  • Endoscopy
  • Robotics
  • Thyroidectomy
  • Papillary Thyroid Carcinoma
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

Exclusion Criteria:

  • Patients without beauty needs.
  • There is lateral neck or mediastinal lymph node metastasis.
  • The tumor invades the nerve and surrounding organs.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: conventional open surgery

  • Experimental
    endoscopic thyroidectomy

    Patients who met the inclusion criteria were selected to undergo thyroid surgery via endoscopic thyroidectomy

    Procedure: endoscopic thyroidectomy

  • Experimental
    robotic thyroidectomy

    Patients who met the inclusion criteria chose the Da Vinci robot for thyroid surgery.

    Device: robotic thyroidectomy

Interventions

  • Procedureconventional open surgery

    conventional open surgery

  • Procedureendoscopic thyroidectomy

    endoscopic thyroidectomy

  • Devicerobotic thyroidectomy

    robotic thyroidectomy

05

What researchers measure

Primary outcomes

  1. operation time

    Assess the operation time

    Time frame: The first day after surgery

  2. recurrent laryngeal nerve palsy

    the number of recurrent laryngeal nerve palsy

    Time frame: 2 months post operation

Secondary outcomes

  1. thyroid volume

    thyroid volume

    Time frame: The day before the operation

  2. cosmetic effect

    The satisfaction with cosmetic outcomes was analyzed quantitatively using a scoring system that ranged from 1 to 4(1, extremely; 2, fairly; 3, normal; 4: not at all) that was rated by patients at the outpatient clinic 2 months after the operation.

    Time frame: 2 months post operation

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03454477
Lead sponsor
Fujian Medical University
Responsible party
Bo Wang,MD (clinical professor, Fujian Medical University) — Principal investigator
First posted
Mar 6, 2018
Start date
Feb 1, 2018
Primary completion
Oct 1, 2018 (estimated)
Completion
Oct 1, 2018 (estimated)
Last update
Sep 18, 2018

Study contacts

bo wang, md
Contact
wangbo@fjmu.edu.cn
13705947900
wenxin zhao, md
Contact
zhaowx@fjmu.edu.cn
13365910359

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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