ThyroidectomyORCNCT01171079
Use of an Oxidized Regenerated Cellulose After Thyroid Surgery: A Prospective, Randomized Study
A study testing application of oxidized regenerated cellulose in people with Thyroidectomy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effects and safety of oxidized, regenerated cellulose as an absorbable adhesion barrier after thyroidectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroidectomy
- What is being tested?
- application of oxidized regenerated cellulose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- operable thyroid neoplasm
Who cannot join
- a history of previous neck surgeries or uncontrolled medical diseases such as hyperthyroidism, diabetes, and hypertension
- administration of non-steroidal anti-inflammatory drugs (NSAIDs) or anti-platelet agents within 1 week before surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University College of Medicine
Seoul, 110-744
About this study
The purpose of this study is to evaluate the effects and safety of oxidized, regenerated cellulose as an absorbable adhesion barrier after thyroidectomy.
- Conditions
- Thyroidectomy
- Being tested
- application of oxidized regenerated cellulose
- Keywords
- postoperative adhesion after thyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of oxidized regenerated celluloseDevice
| Study group | Role | What they receive |
|---|---|---|
| Interceed | Experimental | Not described Receives: Device: application of oxidized regenerated cellulose |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171079
- Sponsor's protocol ID
- ORC-100
- Acronym
- ORC
- Status last verified
- Jul 2010
- First submitted
- 26 Jul 2010
- Last updated
- 28 Jul 2010
- Results posted
- No
Publications
Yigit O, Uslu Coskun B, Coskun H, Yilmaz B, Alkan S, Cinar U, Dadas B. Efficacy of anti-adhesive barriers in secondary thyroidectomy: an experimental study. Laryngoscope. 2004 Sep;114(9):1668-73. doi: 10.1097/00005537-200409000-00031.
PubMed 15475802Yilmaz O, Genc A, Taneli F, Demireli P, Deliaga H, Taneli C. Assessment of the efficacy of absorbable adhesion barriers on dissection in esophagus operations. Int J Pediatr Otorhinolaryngol. 2007 Mar;71(3):409-14. doi: 10.1016/j.ijporl.2006.11.010. Epub 2006 Dec 11.
PubMed 17161874
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Oxidized Regenerated Cellulose After Thyroid Surgery: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT01171079
- Acronym / sponsor ID
- ORC / ORC-100
- Conditions
- Thyroidectomy
- Keywords
- postoperative adhesion after thyroidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- First posted
- 28 Jul 2010 (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.
The purpose of this study is to evaluate the effects and safety of oxidized, regenerated cellulose as an absorbable adhesion barrier after thyroidectomy.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interceed | Experimental | Device: application of oxidized regenerated cellulose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- operable thyroid neoplasm
Key exclusion criteria (2 listed)
- a history of previous neck surgeries or uncontrolled medical diseases such as hyperthyroidism, diabetes, and hypertension
- administration of non-steroidal anti-inflammatory drugs (NSAIDs) or anti-platelet agents within 1 week before surgery
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 |
|---|---|---|
| application of oxidized regenerated cellulose | Device | Interceed |
Primary outcome
Not reported in the source record.
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 28 Jul 2010.
- Background: PubMed 15475802Yigit O, Uslu Coskun B, Coskun H, Yilmaz B, Alkan S, Cinar U, Dadas B. Efficacy of anti-adhesive barriers in secondary thyroidectomy: an experimental study. Laryngoscope. 2004 Sep;114(9):1668-73. doi: 10.1097/00005537-200409000-00031.
- Background: PubMed 17161874Yilmaz O, Genc A, Taneli F, Demireli P, Deliaga H, Taneli C. Assessment of the efficacy of absorbable adhesion barriers on dissection in esophagus operations. Int J Pediatr Otorhinolaryngol. 2007 Mar;71(3):409-14. doi: 10.1016/j.ijporl.2006.11.010. Epub 2006 Dec 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of oxidized regenerated cellulose in people with Thyroidectomy, run by Seoul National University Hospital at 1 site in South Korea.
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 2 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 28 Jul 2010. 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 South Korea. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01171079, which also lists 2 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 28 Jul 2010.