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NCT Number: NCT06014619

Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Skin Cancer Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Complication Complication of Surgical Procedure Complication,Postoperative Cutaneous Squamous Cell Carcinoma Disease Attributes Hutchinson's Melanotic Freckle Lentigo Maligna Lentigo Maligna Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Recurrence Recurrent Disease Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center+

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mohs surgery

Procedure

Treatment of a skin disease by Mohs micrographic surgery technique (frozen sections).

Other names: Mohs micrographic surgery, MMS, Mohs

Slow Mohs surgery

Procedure

Treatment of a skin disease by Slow Mohs technique (formalin fixation and paraffin-embedded sections).

Other names: Slow Mohs

Primary outcomes

  1. Incidence of complications

    Time frame: 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

    Time frame: 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 outcomes

  1. Hazard ratio of predisposing factors for complications

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Clinical Presentation and Surgical Outcomes in Patients With Skin Disorders Treated With Mohs Micrographic Surgery and Slow Mohs.

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 28, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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