Open Thyroid Surgery With Pillow Versus no Pillow for Better Post-operative Outcomes
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial Comparing Post-operative Pain & Outcomes of Open Thyroidectomy; Extended Neck vs No Extended Neck|
- Post-operative pain score [ Time Frame: First postoperative week ] [ Designated as safety issue: No ]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'
- Surgically related complications [ Time Frame: Immediate and after 6 months ] [ Designated as safety issue: No ]Neck exposure, duration of operation, skin incision length, intra-operative blood loss, RLN injury, post-operative hypocalcaemia
- Postoperative pain scores [ Time Frame: Day 0, day 1 and after two weeks ] [ Designated as safety issue: No ]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'
|Study Start Date:||February 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
No Intervention: No extended neck
Patient will not undergo thyroid surgery with extended neck
Experimental: Extended neck
Patients who undergoing thyroid surgeries are positioned with extended neck by using pillow under shoulder in order to facilitate neck exposure and make the surgery easier.
Procedure: Extended neck with standard support or pillow
Patient will undergo thyroid surgery with an extended neck
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620151
|Queen Mary Hospital|
|Hong Kong, Hong Kong|
|Tung Wah Hospital|
|Sheung Wan, Hong Kong|
|Principal Investigator:||Hung Hin, Brian Lang, Dr.||The University of Hong Kong|