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Is the Routine Pressure Dressing After Thyroidectomy Necessary?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patorn Piromchai, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00400465
First received: November 14, 2006
Last updated: March 31, 2015
Last verified: March 2015
  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 Blind (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

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
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: 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 )
Study First Received: November 14, 2006
Last Updated: March 31, 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

ClinicalTrials.gov processed this record on July 24, 2017