Parotid TumorsNCT01983176
Retrospective Clinical Outcome of Parotid Tumor Surgery
An observational study of Parotid Tumors and Postoperative Complications, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The aim of this study was to determine the histopathological results of parotid tumors and postoperative complications after partial superficial or total parotidectomy with facial nerve dissection and superficial musculoaponeurotic system reconstruction. Read more about this study
- Who is it for?
- Ages 10 to 84 years
- Conditions the study is for
- Parotid Tumors, Postoperative Complications
- How many people
- 767 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Nov 2013
- Phase
- Observational
- 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 10 to 84 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who underwent parotid surgery by a single operator in National Taiwan University Hospital from January 2004 to December 2012 were assessed for histopathological results and postoperative complications.
Who may be able to join
- Clinical diagnosis of parotid tumor
- Patients received the surgery of parotid tumor at NTUH by single surgeon ( Prof. Lou) from 2004/01 to 2012/12
Who cannot join
- -Inflammation or infection disease of parotid gland
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to determine the histopathological results of parotid tumors and postoperative complications after partial superficial or total parotidectomy with facial nerve dissection and superficial musculoaponeurotic system reconstruction.
- Conditions
- Parotid Tumors, Postoperative Complications
- Keywords
- Parotid tumor, Partial superficial parotidectomy, Facial palsy
- Medical subject headings
- Parotid Neoplasms, Postoperative Complications, Facial Paralysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial palsy
Record the grade of facial palsy in patients receiving the surgery of parotid tumor
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid TumorsStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 767 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Jen Lou, MD, Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983176
- Sponsor's protocol ID
- 201307054RIND
- Status last verified
- Nov 2013
- First submitted
- 27 Oct 2013
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Clinical Outcome of Parotid Tumor Surgery
- ClinicalTrials.gov ID
- NCT01983176
- Acronym / sponsor ID
- 201307054RIND
- Conditions
- Parotid Tumors, Postoperative Complications
- Keywords
- Parotid tumor, Partial superficial parotidectomy, Facial palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 767 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 13 Nov 2013 (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 aim of this study was to determine the histopathological results of parotid tumors and postoperative complications after partial superficial or total parotidectomy with facial nerve dissection and superficial musculoaponeurotic system reconstruction.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent parotid surgery by a single operator in National Taiwan University Hospital from January 2004 to December 2012 were assessed for histopathological results and postoperative complications.
Key inclusion criteria (2 listed)
- Clinical diagnosis of parotid tumor
- Patients received the surgery of parotid tumor at NTUH by single surgeon ( Prof. Lou) from 2004/01 to 2012/12
Key exclusion criteria (1 listed)
- -Inflammation or infection disease of parotid gland
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Facial palsy
Time frame: 6 months
Record the grade of facial palsy in patients receiving the surgery of parotid tumor
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 26 Nov 2013.
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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.
Pei-Jen Lou, MD, Ph.D principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parotid Tumors and Postoperative Complications, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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 26 Nov 2013. 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 Taiwan. 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.
What does the primary outcome measure?
Facial palsy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2013.