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Is the Routine Pressure Dressing After Thyroidectomy Necessary?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400465
First Posted: November 16, 2006
Last Update Posted: April 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patorn Piromchai, Khon Kaen University
  Purpose

Thyroidectomy is an operation that is commonly performed. After an operation a pressure dressing by Hypafix is usually used due to the belief that it will help to reduce complications such as post-operative bleeding or haematoma. However, the practice is uncomfortable to patients and makes it hard to detect early haematomas.

We carried out a prospective randomised study to study the role of pressure dressing after thyroid surgery by evaluating the amount of fluids collected in the operative bed by ultrasonography compared with normal dressing.


Condition Intervention Phase
Thyroid Neoplasms Thyroid Nodules Graves Disease Goiter Procedure: Normal dressing Procedure: Pressure dressing Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is the Routine Pressure Dressing After Thyroidectomy Necessary? A Prospective Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Patorn Piromchai, Khon Kaen University:

Primary Outcome Measures:
  • amount of fluids collected in the operative bed by ultrasonography [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days ]

Secondary Outcome Measures:
  • Days retained drains [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days ]
  • days of hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days ]
  • complication (bruise,bleeding,wound dehiscence) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days ]

Enrollment: 116
Study Start Date: December 2006
Study Completion Date: September 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control group
Pressure dressing
Procedure: Pressure dressing
Pressure dressing
Experimental: Experimental group
Normal dressing
Procedure: Normal dressing
Normal dressing

Detailed Description:

Thyroidectomy is an operation that is commonly performed. In Department of Otolaryngology, Khonkaen University was performed this operation about 200 cases per years. After an operation a pressure dressing by Hypafix is usually used due to the belief that it will help to reduce complications such as post-operative bleeding or haematoma. However, the practice is uncomfortable to patients and makes it hard to detect early haematomas.

We carried out a prospective randomised study to study the role of pressure dressing after thyroid surgery by evaluating the amount of fluids collected in the operative bed by ultrasonography compared with normal dressing.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients underwent thyroidectomy in Srinagarind hospital, Khonkaen University

Exclusion Criteria:

  • Patients with cervical lymph nodes metastases requiring neck dissection
  • Patients that tissue pathology shown anaplastic carcinoma
  • Patients with clinical or laboratory indicators of coagulation disorders
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400465


Locations
Thailand
Deapartment of Otolaryngology, Srinagarind Hospital, Khonkaen University
Muang, Khonkaen, Thailand, 40000
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Patorn Piromchai, MD Khonkaen University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patorn Piromchai, Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University
ClinicalTrials.gov Identifier: NCT00400465     History of Changes
Other Study ID Numbers: HE49-1009
ISRCTN52660978 ( Registry Identifier: ISRCTN Registry )
First Submitted: November 14, 2006
First Posted: November 16, 2006
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Patorn Piromchai, Khon Kaen University:
thyroid
thyroidectomy
dressing

Additional relevant MeSH terms:
Graves Disease
Thyroid Diseases
Thyroid Nodule
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases