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临床试验/NCT01620151
NCT01620151已完成不适用

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

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2012年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
2
主要终点
Post-operative pain score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All patients who will be undergoing thyroid surgery in Queen Mary Hospital and Tung Wah Hospital.
  • •Age from 18 till 80 years old.

排除标准

  • •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.

研究组 & 干预措施

No extended neck

No Intervention

Patient will not undergo thyroid surgery with extended neck

Extended neck

Experimental

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.

干预措施: Extended neck with standard support or pillow (Procedure)

结局指标

主要结局

Post-operative pain score

时间窗: First postoperative week

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'

次要结局

  • Surgically related complications(Immediate and after 6 months)
  • Postoperative pain scores(Day 0, day 1 and after two weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Lang Hung Hin, Brian

Honorary Clinical Associate Professor

The University of Hong Kong

研究点 (2)

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