Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy: Prospective, Comparative Single-Center Study (CARTO)

January 2, 2026 updated by: Clinique Bizet

A Comparative Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy

The aim of our study is to evaluate the two surgical approaches, standard thyroidectomy and robotic thyroidectomy, in terms of postoperative pain management, scar quality, quality of life, as well as the occurrence of postoperative complications (hypocalcemia, compressive cervical hematoma and nerve stimulation)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75116
        • Recruiting
        • Clinique Bizet
        • Contact:
        • Principal Investigator:
          • Patrick AIDAN, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject aged over 20 years
  • Referred for a thyroidectomy (total or partial)
  • Absence of participation in another clinical study
  • Subject affiliated to a social security scheme or beneficiary of such a scheme
  • Accepts the completion of the various study questionnaires

Exclusion Criteria:

  • Patient under 20 years of age.
  • Patients who have undergone combined radical cervical lymph node dissection
  • Patient with a postoperative wound problem
  • Patient with an underlying systemic disease that may influence the wound healing process
  • Unable to undergo medical follow-up for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
thyroidectomy by robotic surgery via axillary approach
Procedure: thyroidectomy by robotic surgery via axillary approach
thyroidectomy
Active Comparator: Control group
thyroidectomy by standard conventional surgery
Procedure: thyroidectomy by standard conventional surgery
thyroidectomy by standard conventional surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the post-operative quality of life at D30 between the two groups
Time Frame: day 30
thyca-Qol
day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total dysphagia score between the two groups
Time Frame: Day7, Day30 and 3 months
EAT-10 scale
Day7, Day30 and 3 months
Quality of the scar between the two groups
Time Frame: day 30
Vancouver scale
day 30
Assess the functional recovery of the vocal cords
Time Frame: day 7 and day 30
fibroscopy
day 7 and day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Bizet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A01697-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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