Drains should be abandoned following thyroid surgery

ISRCTN	ISRCTN94715414
DOI	https://doi.org/10.1186/ISRCTN94715414
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Paul Redmond
Scientific

Department of Surgery
Cork University Hospital
Wilton
Cork
-
Ireland

Study design	Double-blinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	Drain insertion routinely inserted following thyroid surgery does not benefit patient outcome.
Ethics approval(s)	Ethics Committee of University College Cork (Ireland) approved on the 2nd January 2008 (ref: ECM 3 (dd) 05/02/08)
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2008
Completion date	31/12/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	93
Key inclusion criteria	1. Patients aged 18 - 79 years, either sex 2. Undergoing thyroidectomy
Key exclusion criteria	1. Sternotomy 2. Neck dissection 3. Less than 18 years 4. History of bleeding disorders
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2009

Department of Surgery

Cork
-
Ireland

Cork University Hospital (Ireland)
Not defined

c/o Professor Paul Redmond
Department of Academic Surgery
University College Cork
Wilton
-
Ireland

Website	http://www.cuh.hse.ie/
"ROR"	https://ror.org/04q107642

Other

Investigator initiated and funded (Ireland)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/04/2012		Yes	No