Clinical trial · Interventional
Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy
Randomized Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy
NCT01320813CI-TRIAL-00017247terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to find enough patients who accept randomization of surgical procedures.
Summary
Brief summary (as posted)
The main objective is to compare 12 month complication rates between a new surgical method for thyroidectomy (robot-assisted endoscopic thyroidectomy via a sub-clavical approach) and open thyroidectomy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Goiter | — | UNRESOLVED | — |
| Graves Disease | — | UNRESOLVED | — |
| Thyroiditis | — | UNRESOLVED | — |
| Thyroid Nodule | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Open thyroidectomy | Procedure | — | UNRESOLVED |
| Robot-assisted thyroidectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robot arm
- description
- Patients in this arm will have a thyroidectomy performed using a robot-assisted endoscopic technique.
- interventionNames
- Procedure: Robot-assisted thyroidectomy
- type
- ACTIVE_COMPARATOR
- label
- Open surgery
- description
- Patients in this arm will have a thyroidectomy using an open surgical technique.
- interventionNames
- Procedure: Open thyroidectomy
Primary outcomes (1)
- measure
- Presence/absence of complications (composite score)
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 12 months of follow-up * The patient is a candidate for total thyroidectomy because of a nodular pathology, a diffuse goiter, thyroiditis, or Basedow's disease * Patient has calcitoninemia \< 9 ng/pl * Patient has normal calcemia * Patient has PTH level between 5 ng/l and 75 ng/l * The subject has a normal laryngeal mobility Exclusion Criteria: * The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant * The patient is breastfeeding * The patient is not available for 12 months of follow-up * Subject has a preoperative diagnosis of cancer on fine needle aspiration biopsy of the thyroid or cervical lymph node * Lymph node metastasis strongly suspected clinically and/or sonographically * The subject has an extension of substernal thyroid (diving goiter) * Family history of medullary thyroid cancer * The subject has a history of neck surgery * Contraindication for general anesthesia
References
Publications (0)
Data not yet available
No reference posted for this study.