Condition category
Surgery
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
07/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.diakonessenhuis.nl/

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

  1. 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.

Additional files

Editorial Notes