MiniBlair: Partial Modified Blair Incision on Benign Tumor Parotidectomy Scar's Characteristics

• Sponsor: Western Galilee Hospital-Nahariya (Other)
• Overall Status: Completed
• CT.gov ID: NCT04970875
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Days): 14
• Patients Per Site Per Month: 108.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Salivary Gland Tumor	Other: Questionnaire

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 Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Effect of Parotid Mass Location on Benign Tumor Parotidectomy Scar's Characteristics
• Actual Study Start Date: Jun 1, 2021
• Actual Primary Completion Date: Jun 15, 2021
• Actual Study Completion Date: Jun 15, 2021

Outcome Measures

Primary Outcome Measures

1. Incidence of Treatment-Emergent Adverse Events as assessed by a questionnaire. [1 Year]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galilee Medical Center	Nahariya		Israel

Sponsors and Collaborators

• Western Galilee Hospital-Nahariya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Western Galilee Hospital-Nahariya
• ClinicalTrials.gov Identifier: NCT04970875
• Other Study ID Numbers: NHR010619
• First Posted: Jul 21, 2021
• Last Update Posted: Jul 21, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Salivary Gland Neoplasms

Study Results

No Results Posted as of Jul 21, 2021