Condition category
Surgery
Date applied
18/03/2010
Date assigned
25/03/2010
Last edited
21/01/2013
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

Prof Paul Redmond

ORCID ID

Contact details

Department of Surgery
Cork University Hospital
Wilton
Cork
-
Ireland

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 measures

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

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

http://www.cuh.hse.ie/

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22540955

Publication citations

  1. 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.

Additional files

Editorial Notes