Extended neck with standard support or pillow
ProcedurePatient will undergo thyroid surgery with an extended neck
Other names: neck extension, neck hyper-extension
NCT Number: NCT01620151
Primary: To compare the post-operative pain in patients with neck extension and without neck extension.
Secondary: To determine the benefit of neck exposure and peri-operative complications, which include duration of operation, intra-operative blood loss, recurrent nerve (RLN) injury and hypocalcaemia in both groups.
Hypothesis: Patients who undergoing thyroidectomy without neck extension will have less post-operative pain and there are no significant difference of post-operation complications between both groups.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Queen Mary Hospital, Hong Kong
Conventional open thyroid surgery is still one of the most common operations performed globally. Traditionally, patients who undergoing thyroid surgeries are usually positioned with extended neck by using pillow under shoulder in order to facilitate neck exposure and make the surgery easier. However, the degree of benefit from the extended neck is doubtful and there is little objective evidence that suggest extended neck thyroid surgery offers better outcomes. On the the hand, over-extension of the neck should be avoided because of it is associated with post-operative pain, vomiting, spinal damage and stroke. The objective of the present study is to compare the post-operative pain in patients with neck extension and without neck extension. In addition to that, we also like to determine the benefit of neck exposure and peri-operative complications, which include duration of operation, intra-operative blood loss, recurrent nerve (RLN) injury and hypocalcaemia in both groups. This is a prospective randomized controlled trial, which will be conducted from 1st of March 2012 till 30th September 2012. Given that approximately 300 to 400 patients would undergo thyroid surgery in each year, we estimated 180 patients will be recruited and randomly divided into 2 groups (neck extension and no neck extension) before undergoing open thyroid surgery for this trial. Visual analogue scale (VAS) is used to determine the post-operative pain. Primary end point and other peri-operative variables are then analyzed with SPSS software.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient will undergo thyroid surgery with an extended neck
Other names: neck extension, neck hyper-extension
Time frame: First postoperative week
Post-operative pain ranges from 0 to 10 according to the Visual Analogue pain scale (VAS), and which 0 is 'No pain' and 10 is 'Worst possible pain'
Time frame: Immediate and after 6 months
Neck exposure, duration of operation, skin incision length, intra-operative blood loss, RLN injury, post-operative hypocalcaemia
Time frame: Day 0, day 1 and after two weeks
Post-operative pain ranges from 0 to 10 according to the Visual Analogue pain scale (VAS), and which 0 is 'No pain' and 10 is 'Worst possible pain'
The University of Hong Kong
Other
A Randomized Controlled Trial Comparing Post-operative Pain & Outcomes of Open Thyroidectomy; Extended Neck vs No Extended Neck
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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