Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03201484 |
| Other study ID # |
221947 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
June 26, 2017 |
| Last updated |
June 27, 2017 |
| Start date |
October 2017 |
| Est. completion date |
October 2019 |
Study information
| Verified date |
June 2017 |
| Source |
Guy's and St Thomas' NHS Foundation Trust |
| Contact |
Lolade Giwa, MBBS |
| Phone |
07943864023 |
| Email |
Lolagiwa[@]doctors.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A study correlating patient reported outcomes measured by a validated tool with physical
measurements recorded by 3d photography of patients undergoing parotid resections
Description:
The studies primary aim is to use the FACE-Q (a validated patient reported outcome (PRO)
scale) for patients undergoing parotidectomy to subjectively measure the functional and
aesthetic impact of the surgery1. It is hypothesized that patients undergoing parotidectomy
have long-standing under-reported functional and cosmetic issues. Currently most parotid
defects are not reconstructed. A secondary aim is to objectively analyse the volume of the
parotid gland pre- and post-operatively to guide reconstructive surgery in patient with
parotid tumours.
Head and neck tumours are common. Most salivary gland tumours arise from the parotid gland
and 80% are benign. Tumour resection can be limited/partial, superficial, total or radical
depending upon the pathology2. This can lead to a cosmetic deformity in the pre-auricular
/cheek region, infra-auricular region causing a superior cervical depression (especially if
combined with a neck dissection) and retromandibular regions2,3. More than 50% of patients
report being affected by facial contour abnormalities after parotidectomy and their
deformity can be both visible on direct and lateral facial views4. The cosmetic defect
following parotidectomy has been rated from moderate to severe disgurement5. Facial
disfigurement experienced by head and neck cancer patients has a strong impact on their
quality of life6,7 (both in function and cosmesis). This is accentuated by the central role
of the face in social communication and expression. Despite these facts there is little
evidence on PRO measures post parotidectomies.
PRO's are essential in current medical practice to view success of an intervention from a
patient's perspective. Two types of questionnaires are available- generic (e.g. SF-36) and
disease specific (e.g. FACE- Q). Generic assess the disease effect on the whole person
irrespective of the medical condition. Disease specific assess interventions in a particular
disease. They are more sensitive to detect changes due to focused questions. The FACE-Q
questionnaire is a recently designed gold standard PRO that is disease specific. The FACE-Q
measures 4 domains- satisfaction with facial appearance, adverse effects (both of these
highlight the effects on a specific facial area e.g. lips, eye etc), health-relate quality
of life and process of care (both of these are relevant to al facial patients). It achieves
this as it has over 40 scales each with a series of questions around one central concept.
Patient responses are graded on a 4 point scale and then converted to a score on a scale
from 0-100. A higher score means improved quality of life. There is no overall score, only
scores for each independent scale. As scales are independent only the scales most relevant
to a specific research objective or patient population need be administered. Patients can
complete the questionnaire pre and post operatively to view the impact of the intervention.
An advantage is that it only takes a few minutes to complete. The dis-advantage of the
FACE-Q could be perceived that it was initially developed for aesthetic facial procedures
however the questions are directly applicable for reconstructive facial procedures. Also
research is still undergoing regarding the clinical meaning/clinical significance of the
FACE-Q but it still allows PRO quantitative data pre and post procedure to aid evaluation
There is little reconstruction post parotidectomy. However, the goals of reconstruction are
both functional (e.g. management of weakness of the lower lip or oral continence,
reconstruction of the facial nerve and prevention of Gustatory sweating) and aesthetic2. A
few possible methods have been described for reconstruction. Primary reconstruction of small
defects are usually with local fascial flaps2 e.g. SMAS flaps5 and large defects with muscle
flaps2 e.g. Sternocleidomastoid8. Secondary reconstruction involves fat grafting5 or
correction of lip asymmetry. The main method of reconstruction involves the defect being
analysed and subjectively "compared" to the contralateral side2. Recent papers have
attempted to improve accuracy. Some have reported abnormal volumes i.e. tumour size.
However, they have not reported normal volumes (i.e. size of defect)5.MRI has been used to
measure volume of defects left behind, however this is not totally accurate as it only
measured the largest transverse dimension and requires further expensive imaging5. Therefore
to improve outcomes improved accuracy on the dimensions of the defect is required before
reconstruction.
Furthermore, although some reconstruction outcomes have been measured by subjective
methods8, there is none by a validated questionnaire e.g. the FACE-Q. End points such as
morbidity and mortality and recurrence rates are only one measure of treatment success. In
addition, there are few objective outcomes reported e.g. using a visual analogue scale9 has
been mentioned but this is less accurate than using pre and post op 3D photography.
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). A range of adults from 18-80 years old with
capacity and of any gender or ethnicity will be assessed. 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
3 months up to 1 year post surgery using the FACE-Q and a non-invasive 3D camera.
There is no obvious risk to the patient as a validated questionnaire will be used and a
non-invasive investigation tool. The patient will not be subject to any extra treatment or
time in hospital for this particular group of patients.
No previous trials have been performed that are relevant to this study.
