| - candidate number | 2507 |
| - NTR Number | NTR927 |
| - ISRCTN | ISRCTN82389535 |
| - Date ISRCTN created | 11-apr-2007 |
| - date ISRCTN requested | 24-mrt-2007 |
| - Date Registered NTR | 6-mrt-2007 |
| - Secondary IDs | N/A |
| - Public Title | Use of vessel sealing system (ligasure) thyroid surgery: time saving? A prospective randomized study. |
| - Scientific Title | Use of vessel sealing system (ligasure) thyroid surgery: time saving? A prospective randomized study. |
| - ACRONYM | N/A |
| - hypothesis | Use of a vessel sealing system (ligasure) in thyroid surgery reduces operation-time. |
| - Healt Condition(s) or Problem(s) studied | Thyroidectomy |
| - Inclusion criteria | 1. Indication for total hemithryeoidectomy; 2. age > 18 years; 3. informed consent. |
| - Exclusion criteria | 1. ASA IV and V patients. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Not applicable |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-sep-2005 |
| - planned closingdate | 1-apr-2007 |
| - Target number of participants | 20 |
| - Interventions | Use of vessel sealing system (ligasure) versus conventional knotting for ligation of blood vessels during thyroid surgery. |
| - Primary outcome | 1. Length of operation. |
| - Secondary outcome | 1. Bleeding complications; 2. Nerve damage. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | A. Schiphorst |
| - CONTACT for SCIENTIFIC QUERIES | Th. Dalen, van |
| - Sponsor/Initiator | Diakonessenhuis Utrecht, Department of Surgery |
| - Funding (Source(s) of Monetary or Material Support) | Diakonessenhuis Utrecht, Department of Surgery |
| - Publications | N/A |
| - Brief summary | This study investigates the use of a vessel sealing system (LigaSure) for vessel ligation in thyroid surgery. Patients eligible for hemithyreoidectomy are randomised to either use of LigaSure during surgery or conventional knot-tying. It is hypothysed that the use of LigaSure significanlty reduces operation time and is also safe. |
| - Main changes (audit trail) | |
| - RECORD | 6-mrt-2007 - 16-nov-2009 |
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