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Photographic Rhinometry Following Derm/Mohs Surgery for Skin Cancers

Sponsor
NHS Grampian (Other)
Overall Status
Recruiting
CT.gov ID
NCT05313711
Collaborator
(none)
68
Enrollment
2
Locations
21.5
Anticipated Duration (Months)
34
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Dermatological surgeons and patients routinely notice alterations in nasal shape and size following surgery and reconstruction. There is no uniform approach to objectively measure these changes. Anthropometric measurements are routinely used in rhinoplasty to assess outcomes, but they are time consuming and have not been reported as being used by dermatological surgeons. Soft-tissue measurements in profile photographs have been demonstrated to be useful for objective measurement of nasal change following surgery. This is a follow up study of the pilot study to assess the feasibility of photographic rhinometry as an objective tool, and (ii) to quantify changes following common dermatological surgical procedures on the nose. This follow-up study will aim to recruit a larger population sample to better quantify some of the changes occurring post-operatively.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    68 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study of Use of 'Photographic Rhinometry' Following Derm and Mohs Micrographic Surgery for Skin Cancers: A Follow-up Study
    Actual Study Start Date :
    Nov 17, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcome is to quantify changes following common dermatological surgical procedures on the nose. ["baseline, pre-intervention/procedure/surgery" and "immediately after the intervention/procedure/surgery"]

      Photographs will be taken with a camera in fixed zoom setting with a ruler placed in different anatomical sites before and after surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Gender: Male and female participants

    • Type of cancer: Undergoing surgery for removal of Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC))

    Exclusion Criteria:

    • Cases unable to consent to participation in the study

    • Patients who are unable to complete the study assessments

    • Patients below 18 years of age

    • Patients undergoing surgery for other types of skin cancer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Burnside House, Foresterhill Health Campus, Cornhill Road, Aberdeen United Kingdom AB25 2ZR
    2 The Hillingdon Hospitals NHS Foundation Trust Uxbridge United Kingdom UB8 3NN

    Sponsors and Collaborators

    • NHS Grampian

    Investigators

    • Principal Investigator: Sanjay Rajpara, MD, NHS Grampian

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NHS Grampian
    ClinicalTrials.gov Identifier:
    NCT05313711
    Other Study ID Numbers:
    • 1-075-21
    First Posted:
    Apr 6, 2022
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Skin Neoplasms

    Study Results

    No Results Posted as of Apr 6, 2022