Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A prospective double-blinded randomised clinical trial evaluating the impact of drain insertion versus no drain insertion following thyroid surgery on patient outcome
Acronym
Study hypothesis
Drain insertion routinely inserted following thyroid surgery does not benefit patient outcome.
Ethics approval
Ethics Committee of University College Cork (Ireland) approved on the 2nd January 2008 (ref: ECM 3 (dd) 05/02/08)
Study design
Double-blinded randomised controlled 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
Thyroid surgery
Intervention
Patients are randomised to drain or no drain insertion at the end of surgery. Patients undergo ultrasound 24 and 48 hours post-operatively.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Fluid accumulation in thyroid bed 24 hours post-operatively
Secondary outcome measures
1. Length of post-operative stay
2. Pain using a visual analogue scale
3. Analgesia requirements at 24 hours
4. Fluid accumulated on ultrasound at 48 hours
Overall trial start date
01/01/2008
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged 18 - 79 years, either sex
2. Undergoing thyroidectomy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
93
Participant exclusion criteria
1. Sternotomy
2. Neck dissection
3. Less than 18 years
4. History of bleeding disorders
Recruitment start date
01/01/2008
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Ireland
Trial participating centre
Department of Surgery
Cork
-
Ireland
Sponsor information
Organisation
Cork University Hospital (Ireland)
Sponsor details
c/o Professor Paul Redmond
Department of Academic Surgery
University College Cork
Wilton
-
Ireland
Sponsor type
Not defined
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Ireland)
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22540955
Publication citations
-
Results
Neary PM, O'Connor OJ, Shafiq A, Quinn EM, Kelly JJ, Juliette B, Cahill RA, Barry J, Redmond HP, The impact of routine open nonsuction drainage on fluid accumulation after thyroid surgery: a prospective randomised clinical trial., World J Surg Oncol, 2012, 10, 72, doi: 10.1186/1477-7819-10-72.