Is the Routine Pressure Dressing After Thyroidectomy Necessary? - Tabular View

Tracking Information

First Received Date ^ICMJE

November 14, 2006

Last Updated Date

October 2, 2007

Start Date ^ICMJE

December 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

amount of fluids collected in the operative bed by ultrasonography

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00400465 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Days retained drains
days of hospital stay
complication (bruise,bleeding,wound dehiscence)

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Is the Routine Pressure Dressing After Thyroidectomy Necessary?

Official Title ^ICMJE

Is the Routine Pressure Dressing After Thyroidectomy Necessary? A Prospective Randomized Controlled Study

Brief Summary

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.

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Investigator, Outcomes Assessor)
Primary Purpose:  Treatment

Condition ^ICMJE

Thyroid Neoplasms
Thyroid Nodules
Graves Disease
Goiter

Intervention ^ICMJE

Procedure: Pressure dressing
Procedure: Normal dressing

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

116

Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT ID ^ICMJE

NCT00400465

Responsible Party

Study ID Numbers ^ICMJE

HE49-1009, ISRCTN52660978

Study Sponsor ^ICMJE

Khon Kaen University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Patorn Piromchai, MD

Khonkaen University

Information Provided By

Khon Kaen University

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP