Drains should be abandoned following thyroid surgery

ISRCTN	ISRCTN94715414
DOI	https://doi.org/10.1186/ISRCTN94715414
Protocol serial number	N/A
Sponsor	Cork University Hospital (Ireland)
Funder	Investigator initiated and funded (Ireland)

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

Primary study design	Interventional
Study design	Double-blinded randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Fluid accumulation in thyroid bed 24 hours post-operatively
Key secondary outcome measure(s)	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
Completion date	31/12/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes