Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04968704 |
| Other study ID # |
299483 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
October 1, 2022 |
Study information
| Verified date |
July 2021 |
| Source |
Royal Free Hospital NHS Foundation Trust |
| Contact |
Prateush Singh, MBBChir |
| Phone |
07825877070 |
| Email |
singh.prateush[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of this study is to improve patient satisfaction and outcomes in facial
reconstructive surgery by using 3D clinical photography and computer modelling to help
illustrate and plan the patients' reconstructive journey.
It will be conducted at the Royal Free Hospital department of Plastic and Reconstructive
Surgery, where patients with facial deformities or suspected diagnoses of skin cancer will be
referred from their GP or dermatology services. As is routine standard of care, they will be
reviewed in outpatient settings and the next management steps initiated. Our study will
introduce compulsory 2D and 3D photography and patient satisfaction questionnaires. The
photographs will be used to sit down with the participant and illustrate the intended
surgical reconstruction, keeping them up to date and fully informed of the surgical plan. The
questionnaire, FACE-Q, already validated for facial skin cancer surgery and reconstruction,
will be used to assess their satisfaction at each stage of their reconstructive journey.
The results of the study will benefit each participant and illustrate an improvement in
satisfaction so that such 3D photography, surgical planning with computer models produced by
these 3D images will become a routine part of future patients with facial disfigurement or
cancer requiring reconstruction.
This study will form part of a PhD academic qualification at UCL for one of the research
registrars.
Description:
Setting: Royal Free Hospital, London. Single site. Study Population: Adult patients aged over
18 presenting with;
• Facial defects resulting from cancer or trauma
Consent from the patients will be obtained as soon as possible, during outpatient
consultation.
Study design: observational case series, feasibility study. As this is an open observational
study, there will be no randomization. As numbers of participant's attending with facial skin
cancer defects requiring reconstruction is small, there will not be any sampling.
Expected number of participants: 10. Number determined after discussion with Chief
Investigators as adequate to determine feasibility or incorporating 3D photography, computer
modelling and questionnaires to improve satisfaction. Statistical input from supervisor and
chief investigator, Professor Eva Krumhuber, department of experimental psychology.
Duration of study: 12 months Methodology: Clinic Consultation Patients will be referred to
our craniofacial clinic with either pre-defect or pre-biopsy lesions suspicious of being skin
malignancies, or following biopsy or defect resulting from excision, trauma or Mohs surgery.
If the lesion is suspicious for cancer but has not been diagnosed, this is discussed with the
patient and a biopsy booked. During the consultation the patient is sent for clinical 2D and
3D photography in the Royal Free Hospital Department of Clinical Photography.
If the patient presents to clinic with the defect, multiple pre-defect 2D photographs are
requested from the patient and stored on the hospital protected plastic surgery department
shared drive.
Photography All patients will undergo outpatient 2D and 3D photography in the Royal Free
Hospital Department of Clinical Photography.
Computer modelling All images will be processed using the Vectra XT software from Canfield
Imaging Scientific, inc. used at the Royal Free Hospital Department of Clinical Photography.
From this, 3D images can be layered, accurate calculations made and the size of defects
accurately measured and templated. 3D models can be manipulated to illustrate each stage of
the reconstruction.
Treatment modality Treatment modalities will involve standard of care surgical management,
pre-assessment and post-operative care. This includes skin cancer and craniofacial MDT
multidisciplinary team discussions to plan and decide treatment. This will all take place at
Royal Free Hospital, London.
Patient questionnaires Patients will be asked to complete FACE-Q questionnaires at each
consultation and after each stage of their reconstruction at initial consultation, 6 weeks
post op, 3 months, 6 months and 1 year follow up.
FACE-Q is a validated questionnaire patient reported outcome measure including measures for
satisfaction with facial appearance, health-related quality of life, recovery, early life
impact, adverse effects and satisfaction with process of care (Klassen et al. 2010).
Follow up For patient who have undergone biopsy, they will be reviewed in the plastic surgery
dressings clinic 1 week post op to review the wound; their histology will be discussed in the
skin MDT 4-6 weeks later and the patient informed in a consultation of the results.
If further excision or reconstruction is required, the patient will undergo the required
imaging and computer modelling and undergo the operative procedure. They will then be
reviewed a week later in our dressings clinic and at the next stage of their procedure in 3-4
weeks if staged reconstruction is required. After the final reconstruction, they will be
reviewed in outpatient clinic at 6 weeks, 3 months, 6 months and 1 year follow up.
Data collection and storage:
Data will be collected from source (medical notes, questionnaires, and images), and collected
on a case record form (CRF) and then transferred to an electronic database. The master
database will be recorded by code and will hence be anonymized. Some parts of the medical
records and the data collected for the study will be looked at by authorised persons such as
the members of the research team, regulatory authorities, the Trust, and the sponsors of this
study. They may also be looked at by authorised people to check that the study is being
carried out correctly. All will have a duty of confidentiality.
Anonymised extracts of the database may be transferred securely to UCL for analysis.
Anonymised images may be shared with researchers in the department of surgery and
interventional sciences at UCL.
In some circumstances the data in an anonymous form may be used for preparation of the trial
report, and for submission to Government agencies as part of the procedures.
The data may be required for further studies, in which case further Research Ethics Committee
approval will be sought. Access to personal data is strictly controlled and limited to
authorised personnel only.
Personal data will be stored on paper forms held in a secure, locked office accessible to
authorised personnel only. At the end of the study, personal data in paper form (completed
Case Record Forms) will be archived securely.
The dataset will be used for the sole purpose set out in this protocol. Anonymised raw data
will not be shared with any other organisation or named individual.
In the study, data will be collected from patients in accordance with the patient consent
form, patient information sheet and as described in this protocol.
The data will be appropriately maintained by authorised members of the research team for
statistical analysis.
The Chief Investigator will nominate an individual to process, store and dispose of study
data in accordance with all applicable legal and regulatory requirements, including the Data
Protection Act 1998 and any amendments thereto.
Non anonymised data will not be transferred to any party not identified in the protocol and
will not be processed and/or transferred other than in accordance with the patients' consent.
