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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00400465
Other study ID # HE49-1009
Secondary ID ISRCTN52660978
Status Completed
Phase Phase 4
First received November 14, 2006
Last updated March 31, 2015
Start date December 2006
Est. completion date September 2007

Study information

Verified date March 2015
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority Thailand: Khon Kaen University Ethics Committee for Human Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date September 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

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


Intervention

Procedure:
Normal dressing
Normal dressing
Pressure dressing
Pressure dressing

Locations

Country Name City State
Thailand Deapartment of Otolaryngology, Srinagarind Hospital, Khonkaen University Muang Khonkaen

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

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

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

FALCAO P. [Use of a compressive-compensed dressing in thyroid surgery]. Rev Bras Otorrinolaringol. 1951 May-Jun;19(3A):88-90. Undetermined Language. — View Citation

FALCAO P. [Use of compensated pressure dressing in thyroid surgery]. Rev Paul Med. 1951 Jul;39(1):64-6. Undetermined Language. — View 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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary amount of fluids collected in the operative bed by ultrasonography participants will be followed for the duration of hospital stay, an expected average of 4 days No
Secondary Days retained drains participants will be followed for the duration of hospital stay, an expected average of 4 days No
Secondary days of hospital stay participants will be followed for the duration of hospital stay, an expected average of 4 days No
Secondary complication (bruise,bleeding,wound dehiscence) participants will be followed for the duration of hospital stay, an expected average of 4 days Yes
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