NCT04970875

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

14 days

First QC Date

June 20, 2021

Last Update Submit

April 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

QoL questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The scar characteristics of patient who had undergone parotidectomy for benign neoplasms at our medical center between 2013 and 2019

You may qualify if:

  • Age above 18 years during the surgery
  • Clinical diagnosis of a benign parotid pathology

You may not qualify if:

  • A malignant pathology of the parotid gland
  • Unavailable data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Galilee Medical Center

Nahariya, Israel

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Head and Neck Surgery Unit

Study Record Dates

First Submitted

June 20, 2021

First Posted

July 21, 2021

Study Start

June 1, 2021

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations