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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04970875
Other study ID # NHR010619
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date June 15, 2021

Study information

Verified date April 2023
Source Western Galilee Hospital-Nahariya
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 15, 2021
Est. primary completion date June 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
QoL questionnaire

Locations

Country Name City State
Israel Galilee Medical Center Nahariya

Sponsors (1)

Lead Sponsor Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events as assessed by a questionnaire. 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). 1 Year
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