Condition category
Surgery
Date applied
12/11/2006
Date assigned
13/12/2006
Last edited
02/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Patorn Piromchai

ORCID ID

Contact details

Department of Otolaryngology
Faculty of Medicine
Khon Kaen University
Khon Kaen
40000
Thailand
+66 (081) 5444463
patorn@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00400465

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PDAT

Study hypothesis

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.

Ethics approval

Approval was gained from the ethics committee of Khon Kaen University on the 22nd November 2006 (ref: HE491009).

Study design

Randomised single-blind controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Post-operative bleeding, haematoma

Intervention

After the thyroidectomy was performed, patients were randomised to one of the following groups:
1. Control group: pressure dressings
2. Experimental group: normal dressings

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Amount of fluids collected in the thyroid bed by ultrasonography

Secondary outcome measures

1. Days retained drains
2. Days of hospital stay
3. Complications (bruise, bleeding, wound dehiscence)

Overall trial start date

01/12/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing thyroidectomy in Srinagarind Hospital (Thailand)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

114

Participant exclusion criteria

1. Cervical lymph node metastases requiring neck dissection
2. Tissue pathology that showed anaplastic carcinoma
3. Clinical or laboratory indicators of coagulation disorders

Recruitment start date

01/12/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Thailand

Trial participating centre

Department of Otolaryngology
Khon Kaen
40000
Thailand

Sponsor information

Organisation

Khon Kaen University (Thailand)

Sponsor details

Faculty of Medicine
Mittrapharb Road
Khon Kaen
40000
Thailand
+66 (043) 348373
watcha_b@kku.ac.th

Sponsor type

University/education

Website

http://www.kku.ac.th/eng/

Funders

Funder type

University/education

Funder name

Khon Kaen University (Thailand) - Faculty of Medicine (internally funded)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes