Thyroid NeoplasmsPhase 4NCT00400465
Is the Routine Pressure Dressing After Thyroidectomy Necessary?
A Phase 4 study testing Normal dressing and Pressure dressing in people with Thyroid Neoplasms and Thyroid Nodules, run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Neoplasms, Thyroid Nodules, Graves Disease
- What is being tested?
- Normal dressing and Pressure dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2006to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients underwent thyroidectomy in Srinagarind hospital, Khonkaen University
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Deapartment of Otolaryngology, Srinagarind Hospital, Khonkaen University
Muang, Khonkaen, 40000
About this study
Official title: Is the Routine Pressure Dressing After Thyroidectomy Necessary? A Prospective Randomized Controlled Study
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.
Read the 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.
- Conditions
- Thyroid Neoplasms, Thyroid Nodules, Graves Disease, Goiter
- Being tested
- Normal dressing, Pressure dressing
- Keywords
- thyroid, thyroidectomy, dressing
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule, Graves Disease, Goiter, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal dressingProcedure or surgery
Normal dressing
Pressure dressingProcedure or surgery
Pressure dressing
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Pressure dressing Receives: Procedure: Pressure dressing |
| Experimental group | Experimental | Normal dressing Receives: Procedure: Normal dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of fluids collected in the operative bed by ultrasonography
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary outcomes (3)
Days retained drains
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
days of hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
complication (bruise,bleeding,wound dehiscence)
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startDec 2006
- Primary completionAug 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patorn Piromchai, Khon Kaen University
- Investigators
- Patorn Piromchai, MD, Principal investigator, Khonkaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400465
- Sponsor's protocol ID
- HE49-1009
- Other IDs
- ISRCTN52660978
- Status last verified
- Mar 2015
- First submitted
- 14 Nov 2006
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
FALCAO P. [Use of compensated pressure dressing in thyroid surgery]. Rev Paul Med. 1951 Jul;39(1):64-6. No abstract available. Undetermined Language.
PubMed 14865291FALCAO 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.
PubMed 14876034Abbas 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.
PubMed 11400242Palestini 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.
PubMed 15902052Cichon S, Anielski R, Orlicki P, Krzesiwo-Stempak K. [Post-thyroidectomy hemorrhage]. Przegl Lek. 2002;59(7):489-92. Polish.
PubMed 12516234Agarwal 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.
PubMed 9425841Shaha AR, Jaffe BM. Practical management of post-thyroidectomy hematoma. J Surg Oncol. 1994 Dec;57(4):235-8. doi: 10.1002/jso.2930570406.
PubMed 7990478Piromchai 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.
PubMed 18366712
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Routine Pressure Dressing After Thyroidectomy Necessary? A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00400465
- Acronym / sponsor ID
- HE49-1009
- Conditions
- Thyroid Neoplasms, Thyroid Nodules, Graves Disease, Goiter
- Keywords
- thyroid, thyroidectomy, dressing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 16 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Pressure dressingPressure dressing |
| Experimental group | Experimental | Procedure: Normal dressingNormal dressing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients underwent thyroidectomy in Srinagarind hospital, Khonkaen University
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal dressingNormal dressing | Procedure or surgery | Experimental group |
| Pressure dressingPressure dressing | Procedure or surgery | Control group |
Primary outcome
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
3 secondary outcomes
Days retained drains
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
days of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
complication (bruise,bleeding,wound dehiscence)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Background: PubMed 14865291FALCAO P. [Use of compensated pressure dressing in thyroid surgery]. Rev Paul Med. 1951 Jul;39(1):64-6. No abstract available. Undetermined Language.
- Background: PubMed 14876034FALCAO 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.
- Background: PubMed 11400242Abbas 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.
- Background: PubMed 15902052Palestini 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.
- Background: PubMed 12516234Cichon S, Anielski R, Orlicki P, Krzesiwo-Stempak K. [Post-thyroidectomy hemorrhage]. Przegl Lek. 2002;59(7):489-92. Polish.
- Background: PubMed 9425841Agarwal 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.
- Background: PubMed 7990478Shaha AR, Jaffe BM. Practical management of post-thyroidectomy hematoma. J Surg Oncol. 1994 Dec;57(4):235-8. doi: 10.1002/jso.2930570406.
- Derived from this study: PubMed 18366712Piromchai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patorn Piromchai, MD principal investigator
Khonkaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal dressing and Pressure dressing in people with Thyroid Neoplasms and Thyroid Nodules, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00400465, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.