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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Post-operative Pain

Treatments: Procedure: Extended neck with standard support or pillow

Study type: Interventional

Funder types: Other

Identifiers

NCT01620151

RCTECS001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

No extended neck

No Intervention group

Description:

Patient will not undergo thyroid surgery with extended neck

Extended neck

Experimental group

Description:

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.

Treatment:

Procedure: Extended neck with standard support or pillow