Retrospective Clinical Outcome of Parotid Tumor Surgery | NCT01983176

Studies
Retrospective Clinical Outcome of Parotid Tumor Surgery

NCT01983176

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Nov 26, 2013Estimated

Enrollment

767Actual

Phase

Not provided

Conditions

Parotid Tumors
Postoperative Complications

Interventions

Not provided

Countries

Taiwan

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

Nov 2013

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

Oct 2013

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Oct 27, 2013

First Submission Date that Met QC Criteria

Nov 6, 2013

First Posted Date

Nov 13, 2013Estimated

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

Nov 25, 2013

Last Update Posted Date

Nov 26, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim of this study was to determine the histopathological results of parotid tumors and postoperative complications after partial superficial or total parotidectomy with facial nerve dissection and superficial musculoaponeurotic system reconstruction.

Detailed Description

Not provided

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

767Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Facial palsy	Record the grade of facial palsy in patients receiving the surgery of parotid tumor	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Clinical diagnosis of parotid tumor
Patients received the surgery of parotid tumor at NTUH by single surgeon ( Prof. Lou) from 2004/01 to 2012/12

Exclusion criteria:

-Inflammation or infection disease of parotid gland

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

84 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All patients who underwent parotid surgery by a single operator in National Taiwan University Hospital from January 2004 to December 2012 were assessed for histopathological results and postoperative complications.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pei-Jen Lou, MD, Ph.D	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei	Taiwan	100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D010307	Parotid Neoplasms
D011183	Postoperative Complications
D005158	Facial Paralysis

Ancestor Terms

ID	Term
D012468	Salivary Gland Neoplasms
D009062	Mouth Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided