Is the Routine Pressure Dressing After Thyroidectomy Necessary?

Thyroid Neoplasms Clinical Trial

Official title:

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

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

Related Conditions & MeSH terms

• Goiter
• Graves Disease
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule
• Thyroid Nodules

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