Total Thyroidectomy With Harmonic Scalpel®
Recruitment status was Not yet recruiting
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| First Received Date ICMJE | October 10, 2006 | ||||||||
| Last Updated Date | October 10, 2006 | ||||||||
| Start Date ICMJE | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Postoperative complications | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Total Thyroidectomy With Harmonic Scalpel® | ||||||||
| Official Title ICMJE | Total Thyroidectomy With Harmonic Scalpel® Versus Standard Surgery. Open Multicentric Randomized Controlled Trial | ||||||||
| 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 time,drainage volume, postoperative pain, length of stay and costs without increasing surgical complications |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Harmonic Scalpel | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Enrollment ICMJE | 280 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00385983 | ||||||||
| Other Study ID Numbers ICMJE | CP005 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Brazilian Society of Head and Neck Surgery | ||||||||
| Collaborators ICMJE | Johnson & Johnson | ||||||||
| Investigators ICMJE |
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| Information Provided By | Brazilian Society of Head and Neck Surgery | ||||||||
| Verification Date | October 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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