Is the Routine Pressure Dressing After Thyroidectomy Necessary?

NCT ID: NCT00400465

Last Updated: 2015-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Thyroid Neoplasms Thyroid Nodules Graves Disease Goiter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control group

Pressure dressing

Group Type ACTIVE_COMPARATOR

Pressure dressing

Intervention Type PROCEDURE

Pressure dressing

Experimental group

Normal dressing

Group Type EXPERIMENTAL

Normal dressing

Intervention Type PROCEDURE

Normal dressing

Interventions

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Normal dressing

Normal dressing

Intervention Type PROCEDURE

Pressure dressing

Pressure dressing

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Patorn Piromchai

Department of Otorhinolaryngology, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patorn Piromchai, MD

Role: PRINCIPAL_INVESTIGATOR

Khonkaen University

Locations

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Deapartment of Otolaryngology, Srinagarind Hospital, Khonkaen University

Muang, Khonkaen, Thailand

Site Status

Countries

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Thailand

References

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Shaha AR, Jaffe BM. Practical management of post-thyroidectomy hematoma. J Surg Oncol. 1994 Dec;57(4):235-8. doi: 10.1002/jso.2930570406.

Reference Type BACKGROUND
PMID: 7990478 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18366712 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 14865291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14876034 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11400242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15902052 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12516234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9425841 (View on PubMed)

Other Identifiers

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ISRCTN52660978

Identifier Type: REGISTRY

Identifier Source: secondary_id

HE49-1009

Identifier Type: -

Identifier Source: org_study_id

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