Clinical trial NCT01620151: Open Thyroid Surgery With Pillow Versus no Pillow for Better Post-operative Outcomes
Official title: A Randomized Controlled Trial Comparing Post-operative Pain & Outcomes of Open Thyroidectomy; Extended Neck vs No Extended Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Keywords: Post-operative pain
Wound bleeding requiring exploration
PTH
RLN complication
Hypocalcaemia complication
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative pain score
timeFrame: First postoperative week
Secondary outcomes:
measure: Surgically related complications
timeFrame: Immediate and after 6 months
measure: Postoperative pain scores
timeFrame: Day 0, day 1 and after two weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Sheung Wan
country: Hong Kong
facility: Tung Wah Hospital
Study officials:
affiliation: The University of Hong Kong
name: Hung Hin, Brian Lang, Dr.
role: PRINCIPAL_INVESTIGATOR
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