Open Thyroid Surgery With Pillow Versus no Pillow for Better Post-operative Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial Comparing Post-operative Pain & Outcomes of Open Thyroidectomy; Extended Neck vs No Extended Neck

Conditions
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Post-operative Pain

Intervention / Treatment
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* Procedure: Extended neck with standard support or pillow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who will be undergoing thyroid surgery in Queen Mary Hospital and Tung Wah Hospital. Age from 18 till 80 years old. Exclusion Criteria: Patients with history of bleeding disorder and tendency. Patients with history of cervical spine surgery and disease. Patients with history of RLN injury and underlying cause of hypocalcemia. Patient with mental disorder and subnormal intelligence. Pregnant and lactating women. Patients who is having other surgical problem that needed other surgical procedure performed at the same setting.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No extended neck<br>Patient will not undergo thyroid surgery with extended neck | |
| Experimental: Extended neck<br>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<br>* Patient will undergo thyroid surgery with an extended neck<br>* Other names: neck hyper-extension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain score | 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' | First postoperative week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgically related complications | Neck exposure, duration of operation, skin incision length, intra-operative blood loss, RLN injury, post-operative hypocalcaemia | Immediate and after 6 months | 
| Postoperative pain scores | 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' | Day 0, day 1 and after two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-operative pain, Wound bleeding requiring exploration, PTH, RLN complication, Hypocalcaemia complication