Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT01620151
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2012-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Thyroid Surgery With Pillow Versus no Pillow for Better Post-operative Outcomes
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Post-operative Pain & Outcomes of Open Thyroidectomy; Extended Neck vs No Extended Neck
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: