Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT06014619
Collaborator
(none)
500
1
10
49.9

Study Details

Study Description

Brief Summary

Mohs micro-graphic surgery (Mohs) is a tissue-sparing, surgical treatment for different types of skin cancer (e.g. basal cell carcinoma, squamous cell carcinoma, lentigo maligna (melanoma). It is a procedure performed with frozen sections. Slow Mohs, a variant of micro-graphic surgery, is performed by formalin fixation and paraffin-embedded sections. Both in Mohs and Slow Mohs tumor margins are assessed to achieve complete removal. This study aims to investigate the clinical presentation and outcomes (i.e. complications and recurrence rates) in patients treated with Mohs or Slow Mohs in the dermatology department of the Maastricht University Medical Center+ in Maastricht, the Netherlands.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Clinical Presentation and Surgical Outcomes in Patients With Skin Disorders Treated With Mohs Micrographic Surgery and Slow Mohs.
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Mohs Micrographic Surgery

Patients treated with Mohs Micrographic Surgery in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands

Procedure: Mohs surgery
Treatment of a skin disease by Mohs micrographic surgery technique (frozen sections).
Other Names:
  • Mohs micrographic surgery
  • MMS
  • Mohs
  • Slow Mohs

    Patients treated with Slow Mohs in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands

    Procedure: Slow Mohs surgery
    Treatment of a skin disease by Slow Mohs technique (formalin fixation and paraffin-embedded sections).
    Other Names:
  • Slow Mohs
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of complications [Within 1 month after completion of the surgical intervention.]

      The incidence of complications after Mohs and Slow Mohs, expressed as absolute numbers and percentages.

    2. Incidence of recurrence [Up to 5 year after completion of the surgical intervention.]

      The incidence of complications after Mohs and Slow Mohs, expressed as absolute numbers and percentages. Recurrence is defined as disease relapse after completion of treatment.

    Secondary Outcome Measures

    1. Hazard ratio of predisposing factors for complications [Within 1 month after completion of the surgical intervention.]

      Predisposing factors (patient- and tumor characteristics) for complications after Mohs and Slow Mohs, expressed in Hazard Ratio's and 95% confidence intervals. It is not possible to define the predisposing factors in advance, because this is currently unknown. We hypothesize the presence of diabetes, tobacco use and medication use to be predisposing factors for complications.

    2. Hazard ratio of predisposing factors for recurrence [Up to 5 year after completion of the surgical intervention.]

      Predisposing factors (patient- and tumor characteristics) for recurrences after Mohs and Slow Mohs, expressed in Hazard Ratio's and 95% confidence intervals. It is not possible to define the predisposing factors in advance, because this is currently unknown. We hypothesize incomplete treatment, worse prognostic tumor factors (Stage III of IV, presence of perineural invasion or lymphovascular invasion) to be predisposing factors for recurrence.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients with a cutaneous lesion with an indication for Mohs micrographic surgery or Slow Mohs

    • patients who received a treatment with either Mohs or Slow Mohs between 1 july 2017 and 1 july 2023 at the dermatology department of the Maastricht University Medical Center+.

    Exclusion Criteria:
    • None.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maastricht University Medical Center+ Maastricht Netherlands

    Sponsors and Collaborators

    • Maastricht University Medical Center

    Investigators

    • Principal Investigator: K Mosterd, MD, PhD, Maastricht University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Maastricht University Medical Center
    ClinicalTrials.gov Identifier:
    NCT06014619
    Other Study ID Numbers:
    • 2023-0043
    First Posted:
    Aug 28, 2023
    Last Update Posted:
    Aug 28, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maastricht University Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 28, 2023