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Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy

Primary Purpose

Thyroid Nodule, Goiter, Thyroiditis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Robot-assisted thyroidectomy
Open thyroidectomy
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Nodule focused on measuring da vinci robot, Thyroidectomy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot arm

Open surgery

Arm Description

Patients in this arm will have a thyroidectomy performed using a robot-assisted endoscopic technique.

Patients in this arm will have a thyroidectomy using an open surgical technique.

Outcomes

Primary Outcome Measures

Presence/absence of complications (composite score)
The per or post-operative occurrence of at least one of the following: postoperative hemorrhage requiring reintervention; cervical infection requiring antibiotics and/or surgical intervention; transient or persistent laryngeal paralysis; transient or persistent hypoparathyroidy (calcemia < 1.9 µmol/l). Transiient means < than and persistent means >= 12 months.

Secondary Outcome Measures

Incision size (mm)
Length of incision in the open group, and sum of incision lengths in the robot group.
Patient satisfaction score
Patient satisfaction as regards the incision scar measured using a visual analog scale from 0.0 to 10.0.
Presence/absence of conversion to open technique
For patients in the robot arm: presence/absence of conversion to open technique.
Operating room prep time (min)
Time in minutes necessary to prep the operating room
Presence/absence of per-operative complications
Presence/absence of per-operative complications
Hospital stay (d)
Length of hospitalization in days required after thyroidectomy
Change in thyroglobulinemia (ng/l)
Thyroglobulinemia at 12 months - Thryoglobulinemia as baseline
Change in calcemia (mg/l)
Calcemia on Day 1 - Calcemia at inclusion
Change in calcemia (mg/l)
Calcemia at the control visit (days 7 to 15) - Calcemia at inclusion
Change in calcemia (mg/l)
Calcemia at 12 months - Calcemia at inclusion
Change in phosphoremia (mg/l)
Phosphoremia at 1 day postop - Phosphoremia at inclusion
Change in phosphoremia (mg/l)
Phosphoremia at control visit (days 7 to 15) - Phosphoremia at inclusion
Change in phosphoremia (mg/l)
Phosphoremia at 12 months - Phosphoremia at inclusion
Change in parathormonemia (ng/l)
Parathormonemia on Day 1 post-op - parathormonemia at inclusion
Change in parathormonemia (ng/l)
Parathormonemia at control visit (days 7 to 15) - parathormonemia at inclusion
Change in parathormonemia (ng/l)
Parathormonemia at 12 months - parathormonemia at inclusion
Visual Analog Pain Score
Visual Analog Scale for pain (0.0 to 10.0)
Visual Analog Pain Score
Visual Analog Scale for pain (0.0 to 10.0)
Visual Analog Pain Score
Visual Analog Scale for pain (0.0 to 10.0)
Direct medical costs (€)
Indirect medical costs (€)

Full Information

First Posted
March 22, 2011
Last Updated
March 24, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01320813
Brief Title
Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy
Official Title
Randomized Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Unable to find enough patients who accept randomization of surgical procedures.
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule, Goiter, Thyroiditis, Graves Disease
Keywords
da vinci robot, Thyroidectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot arm
Arm Type
Experimental
Arm Description
Patients in this arm will have a thyroidectomy performed using a robot-assisted endoscopic technique.
Arm Title
Open surgery
Arm Type
Active Comparator
Arm Description
Patients in this arm will have a thyroidectomy using an open surgical technique.
Intervention Type
Procedure
Intervention Name(s)
Robot-assisted thyroidectomy
Intervention Description
Patients will have a thyroidectomy via a robot-assisted (da Vinci robot) endoscopic (subclavical entry)surgical technique.
Intervention Type
Procedure
Intervention Name(s)
Open thyroidectomy
Intervention Description
Patients will have a conventional (non-endoscopic) thyroidectomy using an open surgical technique
Primary Outcome Measure Information:
Title
Presence/absence of complications (composite score)
Description
The per or post-operative occurrence of at least one of the following: postoperative hemorrhage requiring reintervention; cervical infection requiring antibiotics and/or surgical intervention; transient or persistent laryngeal paralysis; transient or persistent hypoparathyroidy (calcemia < 1.9 µmol/l). Transiient means < than and persistent means >= 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incision size (mm)
Description
Length of incision in the open group, and sum of incision lengths in the robot group.
Time Frame
12 months
Title
Patient satisfaction score
Description
Patient satisfaction as regards the incision scar measured using a visual analog scale from 0.0 to 10.0.
Time Frame
12 months
Title
Presence/absence of conversion to open technique
Description
For patients in the robot arm: presence/absence of conversion to open technique.
Time Frame
1 day
Title
Operating room prep time (min)
Description
Time in minutes necessary to prep the operating room
Time Frame
1 day
Title
Presence/absence of per-operative complications
Description
Presence/absence of per-operative complications
Time Frame
1 day
Title
Hospital stay (d)
Description
Length of hospitalization in days required after thyroidectomy
Time Frame
7 to 15 days post-op
Title
Change in thyroglobulinemia (ng/l)
Description
Thyroglobulinemia at 12 months - Thryoglobulinemia as baseline
Time Frame
12 months
Title
Change in calcemia (mg/l)
Description
Calcemia on Day 1 - Calcemia at inclusion
Time Frame
Day 1
Title
Change in calcemia (mg/l)
Description
Calcemia at the control visit (days 7 to 15) - Calcemia at inclusion
Time Frame
Day 7 to 15
Title
Change in calcemia (mg/l)
Description
Calcemia at 12 months - Calcemia at inclusion
Time Frame
12 months
Title
Change in phosphoremia (mg/l)
Description
Phosphoremia at 1 day postop - Phosphoremia at inclusion
Time Frame
Day 1
Title
Change in phosphoremia (mg/l)
Description
Phosphoremia at control visit (days 7 to 15) - Phosphoremia at inclusion
Time Frame
Days 7 to 15
Title
Change in phosphoremia (mg/l)
Description
Phosphoremia at 12 months - Phosphoremia at inclusion
Time Frame
12 months
Title
Change in parathormonemia (ng/l)
Description
Parathormonemia on Day 1 post-op - parathormonemia at inclusion
Time Frame
Day 1
Title
Change in parathormonemia (ng/l)
Description
Parathormonemia at control visit (days 7 to 15) - parathormonemia at inclusion
Time Frame
Days 7 to 15
Title
Change in parathormonemia (ng/l)
Description
Parathormonemia at 12 months - parathormonemia at inclusion
Time Frame
12 months
Title
Visual Analog Pain Score
Description
Visual Analog Scale for pain (0.0 to 10.0)
Time Frame
Day 1
Title
Visual Analog Pain Score
Description
Visual Analog Scale for pain (0.0 to 10.0)
Time Frame
Days 7 to 15
Title
Visual Analog Pain Score
Description
Visual Analog Scale for pain (0.0 to 10.0)
Time Frame
12 months
Title
Direct medical costs (€)
Time Frame
12 months
Title
Indirect medical costs (€)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Lallemant, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
State/Province
Gard
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy

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