Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Lang Hung Hin, Brian, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01620151
First received: March 8, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Post-operative Pain
Procedure: Extended neck with standard support or pillow

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 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'


Secondary Outcome Measures:
  • 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'


Enrollment: 180
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • neck extension
  • neck hyper-extension

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620151

Locations
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Tung Wah Hospital
Sheung Wan, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Hung Hin, Brian Lang, Dr. The University of Hong Kong
  More Information

Publications:
Responsible Party: Dr. Lang Hung Hin, Brian, Honorary Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01620151     History of Changes
Other Study ID Numbers: RCTECS001
Study First Received: March 8, 2012
Last Updated: December 18, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Post-operative pain
Wound bleeding requiring exploration
PTH
RLN complication
Hypocalcaemia complication

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014