Is the routine Pressure Dressing After Thyroidectomy necessary? A prospective randomised controlled study
| ISRCTN | ISRCTN52660978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52660978 |
| ClinicalTrials.gov (NCT) | NCT00400465 |
| Protocol serial number | N/A |
| Sponsor | Khon Kaen University (Thailand) |
| Funder | Khon Kaen University (Thailand) - Faculty of Medicine (internally funded) |
- Submission date
- 12/11/2006
- Registration date
- 13/12/2006
- Last edited
- 01/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Patorn Piromchai
Scientific
Scientific
Department of Otolaryngology
Faculty of Medicine
Khon Kaen University
Khon Kaen
40000
Thailand
| Phone | +66 (081) 5444463 |
|---|---|
| patorn@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single-blind controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Is the routine Pressure Dressing After Thyroidectomy necessary? A prospective randomised controlled study |
| Study acronym | PDAT |
| Study objectives | 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(s) | Approval was gained from the ethics committee of Khon Kaen University on the 22nd November 2006 (ref: HE491009). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Amount of fluids collected in the thyroid bed by ultrasonography |
| Key secondary outcome measure(s) |
1. Days retained drains |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 114 |
| Key inclusion criteria | Patients undergoing thyroidectomy in Srinagarind Hospital (Thailand) |
| Key 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 |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Department of Otolaryngology
Khon Kaen
40000
Thailand
40000
Thailand
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/03/2008 | 01/02/2019 | Yes | No |
Editorial Notes
01/02/2019: Publication reference added
