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Is the Routine Pressure Dressing After Thyroidectomy Necessary?

Primary Purpose

Thyroid Neoplasms, Thyroid Nodules, Graves Disease

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Normal dressing
Pressure dressing
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Neoplasms focused on measuring thyroid, thyroidectomy, dressing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deapartment of Otolaryngology, Srinagarind Hospital, Khonkaen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

Pressure dressing

Normal dressing

Outcomes

Primary Outcome Measures

amount of fluids collected in the operative bed by ultrasonography

Secondary Outcome Measures

Days retained drains
days of hospital stay
complication (bruise,bleeding,wound dehiscence)

Full Information

First Posted
November 14, 2006
Last Updated
March 31, 2015
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT00400465
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasms, Thyroid Nodules, Graves Disease, Goiter
Keywords
thyroid, thyroidectomy, dressing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Pressure dressing
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Normal dressing
Intervention Type
Procedure
Intervention Name(s)
Normal dressing
Intervention Description
Normal dressing
Intervention Type
Procedure
Intervention Name(s)
Pressure dressing
Intervention Description
Pressure dressing
Primary Outcome Measure Information:
Title
amount of fluids collected in the operative bed by ultrasonography
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary Outcome Measure Information:
Title
Days retained drains
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days
Title
days of hospital stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days
Title
complication (bruise,bleeding,wound dehiscence)
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patorn Piromchai, MD
Organizational Affiliation
Khonkaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deapartment of Otolaryngology, Srinagarind Hospital, Khonkaen University
City
Muang
State/Province
Khonkaen
ZIP/Postal Code
40000
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
14865291
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.
Results Reference
background
PubMed Identifier
14876034
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.
Results Reference
background
PubMed Identifier
11400242
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.
Results Reference
background
PubMed Identifier
15902052
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.
Results Reference
background
PubMed Identifier
12516234
Citation
Cichon S, Anielski R, Orlicki P, Krzesiwo-Stempak K. [Post-thyroidectomy hemorrhage]. Przegl Lek. 2002;59(7):489-92. Polish.
Results Reference
background
PubMed Identifier
9425841
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.
Results Reference
background
PubMed Identifier
7990478
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.
Results Reference
background
PubMed Identifier
18366712
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.
Results Reference
derived

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Is the Routine Pressure Dressing After Thyroidectomy Necessary?

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