Clinical trial NCT00400465: Is the Routine Pressure Dressing After Thyroidectomy Necessary?
Official title: Is the Routine Pressure Dressing After Thyroidectomy Necessary? A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thyroid Neoplasms
Thyroid Nodules
Graves Disease
Goiter
Keywords: thyroid
thyroidectomy
dressing
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2006-11-16
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: amount of fluids collected in the operative bed by ultrasonography
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary outcomes:
measure: Days retained drains
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 days
measure: days of hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 days
measure: complication (bruise,bleeding,wound dehiscence)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 days
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Deapartment of Otolaryngology, Srinagarind Hospital, Khonkaen University
state: Khonkaen
Study officials:
affiliation: Khonkaen University
name: Patorn Piromchai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: FALCAO P. [Use of compensated pressure dressing in thyroid surgery]. Rev Paul Med. 1951 Jul;39(1):64-6. No abstract available. Undetermined Language.
citation: FALCAO P. [Use of a compressive-compensed dressing in thyroid surgery]. Rev Bras Otorrinolaringol. 1951 May-Jun;19(3A):88-90. No abstract available. Undetermined Language.
citation: Abbas G, Dubner S, Heller KS. Re-operation for bleeding after thyroidectomy and parathyroidectomy. Head Neck. 2001 Jul;23(7):544-6. doi: 10.1002/hed.1076.
citation: 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.
citation: Cichon S, Anielski R, Orlicki P, Krzesiwo-Stempak K. [Post-thyroidectomy hemorrhage]. Przegl Lek. 2002;59(7):489-92. Polish.
citation: 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.
citation: Shaha AR, Jaffe BM. Practical management of post-thyroidectomy hematoma. J Surg Oncol. 1994 Dec;57(4):235-8. doi: 10.1002/jso.2930570406.
citation: Piromchai P, Vatanasapt P, Reechaipichitkul W, Phuttharak W, Thanaviratananich S. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study. BMC Ear Nose Throat Disord. 2008 Mar 20;8:1. doi: 10.1186/1472-6815-8-1.