- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04970875
Partial Modified Blair Incision on Benign Tumor Parotidectomy Scar's Characteristics (MiniBlair)
April 25, 2023 updated by: Ronen Ohad, Western Galilee Hospital-Nahariya
Effect of Parotid Mass Location on Benign Tumor Parotidectomy Scar's Characteristics
Parotidectomy is the treatment of choice for tumors in the parotid gland, with the modified Blair is the most common incision used.
In our medical center, the incision is tailored to the size and location of the specific parotid tumor.
This retrospective analysis aims to determine the incidence of complications and to assess the relation between the mass and scar characteristics in patients who had undergone parotidectomy.
Study Overview
Detailed Description
The scar characteristics of patient who had undergone parotidectomy for benign neoplasms at our medical center between 2013 and 2019 will be evaluated.
Patients will complete a questionnaire regarding the occurrence of complications.
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nahariya, Israel
- Galilee Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The scar characteristics of patient who had undergone parotidectomy for benign neoplasms at our medical center between 2013 and 2019
Description
Inclusion Criteria:
- Age above 18 years during the surgery
- Clinical diagnosis of a benign parotid pathology
Exclusion Criteria:
- A malignant pathology of the parotid gland
- Unavailable data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events as assessed by a questionnaire.
Time Frame: 1 Year
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The Warmald Parotidectomy Complications Questionnaire consists of five items, each addressing a complication common to parotidectomy: numbness of the ear on the operated side, Frey's syndrome, facial depression or deformity, noticeable scar, and pain or discomfort in the scar.
Subjects are asked to indicate the extent to which they were disturbed by each of these complications on a scale ranging from 1 (never) to 10 (always).
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1 Year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
June 15, 2021
Study Completion (Actual)
June 15, 2021
Study Registration Dates
First Submitted
June 20, 2021
First Submitted That Met QC Criteria
July 11, 2021
First Posted (Actual)
July 21, 2021
Study Record Updates
Last Update Posted (Actual)
April 27, 2023
Last Update Submitted That Met QC Criteria
April 25, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHR010619
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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