Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385983
Status:
UNKNOWN
Last Update Posted:
2006-10-11
First Post:
2006-10-10
Brief Title:
Total Thyroidectomy With Harmonic Scalpel
Sponsor:
Brazilian Society of Head and Neck Surgery
Organization:
Brazilian Society of Head and Neck Surgery
Study Overview
Official Title:
Total Thyroidectomy With Harmonic Scalpel Versus Standard Surgery Open Multicentric Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Harmonic scalpel is a new surgical instrument Its use has been recommended in patients submitted to total thyroidectomy Few randomized controlled trials has been published However they had small sample sizes used intermediate outcomes and included different surgical procedures
Our objective is to asses the use of Harmonic scalpel in patients submitted to total thyroidectomy using surgical complications operative time drainage volume postoperative pain length of stay and costs as outcomes Our hypothesis is that Harmonic scalpel decreases operative timedrainage volume postoperative pain length of stay and costs without increasing surgical complications
Our objective is to asses the use of Harmonic scalpel in patients submitted to total thyroidectomy using surgical complications operative time drainage volume postoperative pain length of stay and costs as outcomes Our hypothesis is that Harmonic scalpel decreases operative timedrainage volume postoperative pain length of stay and costs without increasing surgical complications
Detailed Description:
This is a multicentric open phase IV randomized controlled trial comparing patients submitted to total thyroidectomy comparing standard surgical procedure versus Harmonic scalpel assisted procedure Adult patients with benign or malignant thyroid disease and normal function will be included Patients with giant goiter hyperthyroidism non differentiated thyroid carcinoma locally invasive tumors neck dissection previous neck radiotherapy or chemotherapy video assisted surgery and severe comorbidities will be excluded calculated sample size was 280 patients Outcomes will be assessed by an independent monitor All centers will made a previous standardization of surgical procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None