|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00892164 |
|
Date of registration:
|
30/04/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer
|
|
Scientific title:
|
Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer: a Prospective Randomized Study |
|
Date of first enrolment:
|
August 2008 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00892164 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Greece
| | | | | | | |
|
Contacts
|
|
Name:
|
Andreas Manouras, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- total thyroidectomy
Exclusion Criteria:
- hemithyroidectomy or subtotal thyroidectomy
- additional surgical procedures together with the total thyroidectomy (i.e.,
parathyroidectomy or cervical lymph node dissection)
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Thyroidectomy
|
|
Intervention(s)
|
|
Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE)
|
|
Device: harmonic scalpel device (FOCUS)
|
|
Primary Outcome(s)
|
|
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
[Time Frame: postoperatively (from the day of surgery until 3-6 months postoperatively)]
|
|
Hemostasis
[Time Frame: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively)]
|
|
Operative time
[Time Frame: from skin incision to skin closure]
|
|
Secondary Outcome(s)
|
|
Length of hospital stay
[Time Frame: postoperatively (from the day of surgery until discharge)]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|