Is the Routine Pressure Dressing After Thyroidectomy Necessary? - Full Text View

Sponsored by:	Khon Kaen University
Information provided by:	Khon Kaen University
ClinicalTrials.gov Identifier:	NCT00400465

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: Pressure dressing Procedure: Normal dressing	Phase IV

MedlinePlus related topics: Cancer Thyroid Cancer Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Is the Routine Pressure Dressing After Thyroidectomy Necessary? A Prospective Randomized Controlled Study

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:

amount of fluids collected in the operative bed by ultrasonography

Secondary Outcome Measures:

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

Enrollment:	116
Study Start Date:	December 2006
Study Completion Date:	September 2007

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

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400465

Locations

Thailand, Khonkaen
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:

FALCAO P. [Use of compensated pressure dressing in thyroid surgery.] Rev Paul Med. 1951 Jul;39(1):64-6. Undetermined Language. No abstract available.

FALCAO P. [Use of a compressive-compensed dressing in thyroid surgery.] Rev Bras Otorinolaringol. 1951 May-Jun;19(3A):88-90. Undetermined Language. No abstract available.

Abbas G, Dubner S, Heller KS. Re-operation for bleeding after thyroidectomy and parathyroidectomy. Head Neck. 2001 Jul;23(7):544-6.

Palestini N, Tulletti V, Cestino L, Durando R, Freddi M, Sisti G, Robecchi A. [Post-thyroidectomy cervical hematoma] Minerva Chir. 2005 Feb;60(1):37-46. Italian.

Cichon S, Anielski R, Orlicki P, Krzesiwo-Stempak K. [Post-thyroidectomy hemorrhage] Przegl Lek. 2002;59(7):489-92. Polish.

Agarwal A, Mishra SK. Post-thyroidectomy haemorrhage: an analysis of critical factors in successful management. J Indian Med Assoc. 1997 Jul;95(7):418-9, 433.

Shaha AR, Jaffe BM. Practical management of post-thyroidectomy hematoma. J Surg Oncol. 1994 Dec;57(4):235-8.

Study ID Numbers:	HE49-1009, ISRCTN52660978
Study First Received:	November 14, 2006
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00400465 History of Changes
Health Authority:	Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:

thyroid
thyroidectomy
dressing

Study placed in the following topic categories:

Goiter
Autoimmune Diseases
Thyroid Neoplasms
Thyroid Nodule
Eye Diseases
Graves Disease
Endocrine System Diseases

Head and Neck Neoplasms
Graves' Disease
Endocrinopathy
Orbital Diseases
Thyroid Diseases
Hyperthyroidism
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Goiter
Autoimmune Diseases
Immune System Diseases
Thyroid Neoplasms
Thyroid Nodule
Eye Diseases
Graves Disease
Endocrine System Diseases

Exophthalmos
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Orbital Diseases
Hyperthyroidism
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009