Contact information
Type
Scientific
Primary contact
Dr A Schiphorst
ORCID ID
Contact details
Diakonessenhuis Utrecht
Department of Surgery
P.O. Box 80250
Utrecht
3508 TG
Netherlands
+31 (0)30 256 6242
aschiphorst@diakhuis.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Use of a vessel sealing system (ligasure) in thyroid surgery reduces operation time.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Thyroidectomy
Intervention
Use of vessel sealing system (ligasure) versus conventional knotting for ligation of blood vessels during thyroid surgery.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Length of operation.
Secondary outcome measures
1. Bleeding complications
2. Nerve damage
Overall trial start date
01/09/2005
Overall trial end date
01/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Indication for total hemithryeoidectomy
2. Age greater than 18 years
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
1. American Society of Anaesthesiologists (ASA) IV and V patients
Recruitment start date
01/09/2005
Recruitment end date
01/04/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Diakonessenhuis Utrecht
Utrecht
3508 TG
Netherlands
Sponsor information
Organisation
Diakonessenhuis Hospital Utrecht (The Netherlands)
Sponsor details
Department of Surgery
P.O. Box 80250
Utrecht
3508 TG
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Diakonessenhuis Utrecht (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22257756
Publication citations
-
Results
Schiphorst AH, Twigt BA, Elias SG, van Dalen T, Randomized clinical trial of LigaSure versus conventional suture ligation in thyroid surgery., Head Neck Oncol, 2012, 4, 2, doi: 10.1186/1758-3284-4-2.