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

NCT ID: NCT01620151

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Post-operative Pain

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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No extended neck

Patient will not undergo thyroid surgery with extended neck

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Extended neck with standard support or pillow

Intervention Type PROCEDURE

Patient will undergo thyroid surgery with an extended neck

Interventions

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Extended neck with standard support or pillow

Patient will undergo thyroid surgery with an extended neck

Intervention Type PROCEDURE

Other Intervention Names

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neck extension neck hyper-extension

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Lang Hung Hin, Brian

Honorary Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hung Hin, Brian Lang, Dr.

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Tung Wah Hospital

Sheung Wan, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type BACKGROUND
PMID: 19199002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15933531 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11510599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14616561 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9707207 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16105529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17479325 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12807591 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 7431615 (View on PubMed)

Other Identifiers

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RCTECS001

Identifier Type: -

Identifier Source: org_study_id