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| Tracking Information | |||||
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| First Received Date ICMJE | July 21, 2007 | ||||
| Last Updated Date | July 25, 2007 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00506103 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study | ||||
| Official Title ICMJE | |||||
| Brief Summary | To investigate the safety and efficacy of the no-tie technique using the harmonic scalpel (HS) in terms of the operating time and complications in total thyroidectomy with central neck dissection (CND). Recently, the HS has been used as an alternative to conventional hand-tied ligation for hemostasis in thyroid surgery, which is a time-consuming procedure. Very limited data have been published on evidence of its safety in total thyroidectomy accompanied by CND without supplementary hand-tied ligation. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History, Longitudinal, Defined Population, Prospective Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | Cordon C, Fajardo R, Ramirez J, Herrera MF. A randomized, prospective, parallel group study comparing the Harmonic Scalpel to electrocautery in thyroidectomy. Surgery. 2005 Mar;137(3):337-41. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | June 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00506103 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | SCHHN | ||||
| Study Sponsor ICMJE | Soonchunhyang University Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Soonchunhyang University Hospital | ||||
| Verification Date | July 2007 | ||||
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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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