Partial Modified Blair Incision on Benign Tumor Parotidec... | NCT04970875

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

NCT04970875

Sponsor

Western Galilee Hospital-Nahariya

Status

Completed

Last Update Posted

Apr 27, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Salivary Gland Tumor

Interventions

Questionnaire

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Jun 15, 2021Actual

Completion Date

Jun 15, 2021Actual

First Submitted Date

Jun 20, 2021

First Submission Date that Met QC Criteria

Jul 11, 2021

First Posted Date

Jul 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2023

Last Update Posted Date

Apr 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ronen Ohad, Director Head and Neck Surgery Unit, Western Galilee Hospital-NahariyaPrincipal Investigator

Lead Sponsor

Western Galilee Hospital-NahariyaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	QoL questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Galilee Medical Center		Nahariya			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012468	Salivary Gland Neoplasms

Ancestor Terms

ID	Term
D009062	Mouth Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided