NCT01983176

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
767

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

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

October 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2013

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

1 month

First QC Date

October 27, 2013

Last Update Submit

November 25, 2013

Conditions

Parotid TumorsPostoperative Complications

Keywords

Parotid tumorPartial superficial parotidectomyFacial palsy

Outcome Measures

Primary Outcomes (1)

  • Facial palsy

    Record the grade of facial palsy in patients receiving the surgery of parotid tumor

    6 months

Eligibility Criteria

Age10 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Inflammation or infection disease of parotid gland

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Parotid NeoplasmsPostoperative ComplicationsFacial Paralysis

Condition Hierarchy (Ancestors)

Salivary Gland NeoplasmsMouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesParotid DiseasesSalivary Gland DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsParalysisNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Pei-Jen Lou, MD, Ph.D

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2013

First Posted

November 13, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

TW(1)