Computer Modelling to Plan Surgical Reconstruction

NCT04968704 | Unknown DMC

• 1 other identifier: 299483
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Surgery; Cancer of Skin

Keywords

facial reconstruction; computer modeling; plastic surgery; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• To determine if increasing utilisation of 3D photography and computer modelling in facial reconstructive surgery changes patient satisfaction during their reconstructive journey.

  using the validated FACE-Q questionnaire for patients with skin cancer

  at start of study at at 6 months

Study Arms (1)

patients undergoing facial reconstructive surgery

Patients with facial cancer or disfigurement who require reconstructive surgery will be offered participation in this study.

Other: 3D photography and computer modelling

Interventions

3D photography and computer modelling OTHER

3D photography is available at our unit department of clinical photography. Photos will be taken and the associated NHS software (Canfield Imaging scientific, inc) used to sit down with the patients and model their reconstruction, thereby reducing anxiety and improving awareness of their treatment plan.

patients undergoing facial reconstructive surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with facial skin cancer or disfigurement as a result of trauma or congenital abnormality requiring reconstructive surgery

You may qualify if:

• Participants requiring to undergo facial reconstructive surgery as a result of defects from cancer, trauma or congenital abnormality.
• Participants aged 18 years old or over

You may not qualify if:

• If unable to provide written informed consent.
• Younger than 18 years.
• Patients with lesions or defects on the scalp, ears or neck

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead

Biospecimen

Retention: SAMPLES WITH DNA

facial skin cancers must be excised- this tissue will be sent to the Royal Free Hospital department of histopathology for review as is standard of care for these patients.

MeSH Terms

Conditions

Skin Neoplasms; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• prateush singh, mbbchir

  royal free hospital ACF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prateush Singh, MBBChir

CONTACT

07825877070; singh.prateush@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NIHR Academic Clinical Fellow

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 20, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share