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

NCT01620151 | Completed

• 1 other identifier: RCTECS001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-operative Pain

Keywords

Post-operative pain; Wound bleeding requiring exploration; PTH; RLN complication; Hypocalcaemia complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Surgically related complications

  Immediate and after 6 months

• Postoperative pain scores

  Day 0, day 1 and after two weeks

Study Arms (2)

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.

Procedure: Extended neck with standard support or pillow

Interventions

Extended neck with standard support or pillow PROCEDURE

Patient will undergo thyroid surgery with an extended neck

Also known as: neck extension, neck hyper-extension

Extended neck

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Tung Wah Hospital

Sheung Wan, Hong Kong

Location

Related Publications (9)

• Bae JS, Park WC, Song BJ, Jung SS, Kim JS. Endoscopic thyroidectomy and sentinel lymph node biopsy via an anterior chest approach for papillary thyroid cancer. Surg Today. 2009;39(2):178-81. doi: 10.1007/s00595-008-3840-5. Epub 2009 Feb 7.

  PMID: 19199002 BACKGROUND

• Terris DJ, Bonnett A, Gourin CG, Chin E. Minimally invasive thyroidectomy using the Sofferman technique. Laryngoscope. 2005 Jun;115(6):1104-8. doi: 10.1097/01.MLG.0000163761.03764.44.

  PMID: 15933531 BACKGROUND

• Park CS, Chung WY, Chang HS. Minimally invasive open thyroidectomy. Surg Today. 2001;31(8):665-9. doi: 10.1007/s005950170066.

  PMID: 11510599 BACKGROUND

• Serpell JW, Grodski SF, O'Donell C. Does neck extension elevate the thyroid gland cephalad to potentially improve access during thyroidectomy? ANZ J Surg. 2003 Nov;73(11):887-9. doi: 10.1046/j.1445-2197.2003.02845.x.

  PMID: 14616561 BACKGROUND

• Weintraub MI, Khoury A. Cerebral hemodynamic changes induced by simulated tracheal intubation: a possible role in perioperative stroke? Magnetic resonance angiography and flow analysis in 160 cases. Stroke. 1998 Aug;29(8):1644-9. doi: 10.1161/01.str.29.8.1644.

  PMID: 9707207 BACKGROUND

• Lang BH, Lo CY. Total thyroidectomy for multinodular goiter in the elderly. Am J Surg. 2005 Sep;190(3):418-23. doi: 10.1016/j.amjsurg.2005.03.029.

  PMID: 16105529 BACKGROUND

• Clements RH, Palepu R. In vivo comparison of the coagulation capability of SonoSurg and Harmonic Ace on 4 mm and 5 mm arteries. Surg Endosc. 2007 Dec;21(12):2203-6. doi: 10.1007/s00464-007-9345-2. Epub 2007 May 4.

  PMID: 17479325 BACKGROUND

• Warden V, Hurley AC, Volicer L. Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. J Am Med Dir Assoc. 2003 Jan-Feb;4(1):9-15. doi: 10.1097/01.JAM.0000043422.31640.F7.

  PMID: 12807591 BACKGROUND

• Beaver WT. Management of cancer pain with parenteral medication. JAMA. 1980 Dec 12;244(23):2653-7. No abstract available.

  PMID: 7431615 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hung Hin, Brian Lang, Dr.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Associate Professor

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: June 15, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

HK (2)