Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient Reported Outcomes Following Parotid Resections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201484
Recruitment Status : Unknown
Verified June 2017 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:
A study correlating patient reported outcomes measured by a validated tool with physical measurements recorded by 3d photography of patients undergoing parotid resections

Condition or disease Intervention/treatment
Parotidectomy, Patient-reported Outcomes Other: FACE-Q questionnaire, 3D photography

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Reported Outcomes Following Parotid Resections: Version 2
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 2019

Intervention Details:
  • Other: FACE-Q questionnaire, 3D photography
    FACE-Q questionnaire, 3D photography


Primary Outcome Measures :
  1. Patient Reported Outcomes as measured by the validated FACE-Q questionnaire [ Time Frame: 1 year ]
    Patient Reported Outcomes as measured by the validated FACE-Q questionnaire

  2. Physical cheek defect as measured with 3D photography [ Time Frame: 1 year ]
    Patient Reported Outcomes as measured by the validated FACE-Q questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will look at prospective analysis of 50 consecutive patients undergoing parotidectomy by consultant head and neck surgeons (ENT and maxillofacial surgeons) at 1 academic tertiary centre (Guy's Hospital). It is expected all patients will be recruited within 1 year (based on previous hospital data). A range of adults from 18-80 years old and of any gender or ethnicity will be recruited from the Head and Neck cancer MDT clinic. Patients having both benign and malignant parotid resection with either partial or superficial or total parotidectomy or neck dissection will be included. Data to be collected includes pre-operative FACE-Q analysis and non-invasive 3D camera measurements, demographic data, tumour pathology, tumour size, defect size, postoperative radiation and duration of follow-up. Follow up will be from 6 weeks up to 1 year post surgery using the FACE-Q and a non-invasive 3D camera. No previous trials have been performed that are relevant to this study.
Criteria

Inclusion Criteria:

- Adults 18-80 years old. Any gender. Any ethnicity. Capacity to participate in the study. Patients having both benign and malignant parotid tumours for resection including having a neck dissection.

Patients having both primary superficial or total parotidectomy.

Exclusion Criteria:

  • Children (< 18 years old). Adults > 80 years old i.e. too old for surgery/follow up Patients without capacity. Primary parotid surgery (not secondary procedures). Patients having radical parotidectomy with additional facial nerve sacrifice. Patients have immediate reconstruction (e.g. with free flap). Previous/current facial surgery/co-morbidity e.g. facial palsy Co-morbidity precluding surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201484


Contacts
Layout table for location contacts
Contact: Lolade Giwa, MBBS 07943864023 Lolagiwa@doctors.org
Contact: William Townley, MD 02071887188 William.townley@gstt.org.uk

Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Layout table for additonal information
Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03201484    
Other Study ID Numbers: 221947
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017