Is the Routine Pressure Dressing After Thyroidectomy Necessary?

• Sponsor: Khon Kaen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00400465
• Collaborator: (none)
• Enrollment: 116
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 12.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Neoplasms; Thyroid Nodules; Graves Disease; Goiter	Procedure: Normal dressing; Procedure: Pressure dressing	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Is the Routine Pressure Dressing After Thyroidectomy Necessary? A Prospective Randomized Controlled Study
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group Pressure dressing	Procedure: Pressure dressing; Pressure dressing
Experimental: Experimental group Normal dressing	Procedure: Normal dressing; Normal dressing

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. Days retained drains [participants will be followed for the duration of hospital stay, an expected average of 4 days]

2. days of hospital stay [participants will be followed for the duration of hospital stay, an expected average of 4 days]

3. complication (bruise,bleeding,wound dehiscence) [participants will be followed for the duration of hospital stay, an expected average of 4 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Abbas G, Dubner S, Heller KS. Re-operation for bleeding after thyroidectomy and parathyroidectomy. Head Neck. 2001 Jul;23(7):544-6.
• 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.
• Cichoń S, Anielski R, Orlicki P, Krzesiwo-Stempak K. [Post-thyroidectomy hemorrhage]. Przegl Lek. 2002;59(7):489-92. Polish.
• FALCAO P. [Use of a compressive-compensed dressing in thyroid surgery]. Rev Bras Otorrinolaringol. 1951 May-Jun;19(3A):88-90. Undetermined Language.
• FALCAO P. [Use of compensated pressure dressing in thyroid surgery]. Rev Paul Med. 1951 Jul;39(1):64-6. Undetermined Language.
• 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.
• Shaha AR, Jaffe BM. Practical management of post-thyroidectomy hematoma. J Surg Oncol. 1994 Dec;57(4):235-8.

• Responsible Party: Patorn Piromchai, Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University
• ClinicalTrials.gov Identifier: NCT00400465
• Other Study ID Numbers: HE49-1009; ISRCTN52660978
• First Posted: Nov 16, 2006
• Last Update Posted: Apr 1, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Patorn Piromchai, Department of Otorhinolaryngology, Faculty of Medicine, Khon Kaen University: thyroid; thyroidectomy; dressing
• Additional relevant MeSH terms: Thyroid Nodule; Thyroid Neoplasms; Graves Disease; Thyroid Diseases

Study Results

No Results Posted as of Apr 1, 2015