NCT06693258

Brief Summary

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress91%
Nov 2024Jul 2026

First Submitted

Initial submission to the registry

November 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

November 25, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

November 12, 2024

Last Update Submit

January 2, 2026

Conditions

Carpal Tunnel Surgery

Outcome Measures

Primary Outcomes (1)

  • Evaluate the post-operative quality of life at D30 between the two groups

    thyca-Qol

    day 30

Secondary Outcomes (3)

  • Total dysphagia score between the two groups

    Day7, Day30 and 3 months

  • Quality of the scar between the two groups

    day 30

  • Assess the functional recovery of the vocal cords

    day 7 and day 30

Study Arms (2)

Experimental group

EXPERIMENTAL

thyroidectomy by robotic surgery via axillary approach

Procedure: thyroidectomy by robotic surgery via axillary approach

Control group

ACTIVE COMPARATOR

thyroidectomy by standard conventional surgery

Procedure: thyroidectomy by standard conventional surgery

Interventions

thyroidectomy by robotic surgery via axillary approachPROCEDURE

thyroidectomy

Experimental group
thyroidectomy by standard conventional surgeryPROCEDURE

thyroidectomy by standard conventional surgery

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

clinique Bizet

Paris, 75116, France

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective, Comparative, Monocentric Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 18, 2024

Study Start

November 25, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)